Trial Outcomes & Findings for Efficacy and Safety of Prepopik® in Children for Overall Colon Cleansing in Preparation for Colonoscopy (NCT NCT01928862)
NCT ID: NCT01928862
Last Updated: 2018-04-23
Results Overview
Aronchick scale is a 4-point scale that grades colon cleansing as Excellent (\>90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization), Good (\>90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization), Fair (\>90% of mucosa seen, mixture of liquid and semisolid stool, could be suctioned and/or washed) or Inadequate (\<90% of mucosa seen, mixture of semisolid and solid stool which could not be suctioned or washed). The participant is considered to be a responder if overall colon cleansing is "excellent" or "good" on this 4-point scale.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
78 participants
Primary outcome timeframe
On the day of colonoscopy
Results posted on
2018-04-23
Participant Flow
Participants were recruited at 9 investigative sites in the United States (US).
Eighty participants were screened out of which 78 participants were randomized in this trial. Two were screening failures (participant not fulfilling inclusion/exclusion criteria \[n=1\], other \[n=1\]).
Participant milestones
| Measure |
Prepopik® ½ Sachet x 2 (9-12 Years)
Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in "Split Dose" method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.
"Day Before" method was the alternative method if "Split Dose" was not appropriate. In "Day Before" method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.
The dose was ½ sachet for this subset of participants (9-12 years old).
|
Prepopik® 1 Sachet x 2 (9-12 Years)
Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in "Split Dose" method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.
"Day Before" method was the alternative method if "Split Dose" was not appropriate. In "Day Before" method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.
The dose was 1 sachet for this subset of participants (9-12 years old).
|
Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years)
Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (9-12 years old).
|
Prepopik® 1 Sachet x 2 (13-16 Years)
Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in "Split Dose" method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.
"Day Before" method was the alternative method if "Split Dose" was not appropriate. In "Day Before" method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.
The dose was 1 sachet for this subset of participants (13-16 years old).
|
Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years)
Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (13-16 years old).
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
16
|
16
|
14
|
|
Overall Study
COMPLETED
|
15
|
16
|
16
|
16
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Prepopik® ½ Sachet x 2 (9-12 Years)
Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in "Split Dose" method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.
"Day Before" method was the alternative method if "Split Dose" was not appropriate. In "Day Before" method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.
The dose was ½ sachet for this subset of participants (9-12 years old).
|
Prepopik® 1 Sachet x 2 (9-12 Years)
Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in "Split Dose" method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.
"Day Before" method was the alternative method if "Split Dose" was not appropriate. In "Day Before" method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.
The dose was 1 sachet for this subset of participants (9-12 years old).
|
Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years)
Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (9-12 years old).
|
Prepopik® 1 Sachet x 2 (13-16 Years)
Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in "Split Dose" method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.
"Day Before" method was the alternative method if "Split Dose" was not appropriate. In "Day Before" method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.
The dose was 1 sachet for this subset of participants (13-16 years old).
|
Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years)
Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (13-16 years old).
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of Prepopik® in Children for Overall Colon Cleansing in Preparation for Colonoscopy
Baseline characteristics by cohort
| Measure |
Prepopik® ½ Sachet x 2 (9-12 Years)
n=16 Participants
Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in "Split Dose" method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.
"Day Before" method was the alternative method if "Split Dose" was not appropriate. In "Day Before" method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.
The dose was ½ sachet for this subset of participants (9-12 years old).
|
Prepopik® 1 Sachet x 2 (9-12 Years)
n=16 Participants
Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in "Split Dose" method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.
"Day Before" method was the alternative method if "Split Dose" was not appropriate. In "Day Before" method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.
The dose was 1 sachet for this subset of participants (9-12 years old).
|
Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years)
n=16 Participants
Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (9-12 years old).
|
Prepopik® 1 Sachet x 2 (13-16 Years)
n=16 Participants
Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in "Split Dose" method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.
"Day Before" method was the alternative method if "Split Dose" was not appropriate. In "Day Before" method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.
The dose was 1 sachet for this subset of participants (13-16 years old).
|
Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years)
n=14 Participants
Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (13-16 years old).
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
10.8 years
STANDARD_DEVIATION 1.00 • n=5 Participants
|
10.5 years
STANDARD_DEVIATION 1.21 • n=7 Participants
|
10.4 years
STANDARD_DEVIATION 1.20 • n=5 Participants
|
15.0 years
STANDARD_DEVIATION 1.03 • n=4 Participants
|
14.9 years
STANDARD_DEVIATION 0.92 • n=21 Participants
|
12.2 years
STANDARD_DEVIATION 2.41 • n=8 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
53 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
25 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
74 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
71 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: On the day of colonoscopyPopulation: The primary efficacy analysis was based on the intention-to-treat (ITT) analysis set, which included all participants who were randomized.
Aronchick scale is a 4-point scale that grades colon cleansing as Excellent (\>90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization), Good (\>90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization), Fair (\>90% of mucosa seen, mixture of liquid and semisolid stool, could be suctioned and/or washed) or Inadequate (\<90% of mucosa seen, mixture of semisolid and solid stool which could not be suctioned or washed). The participant is considered to be a responder if overall colon cleansing is "excellent" or "good" on this 4-point scale.
Outcome measures
| Measure |
Prepopik® ½ Sachet x 2 (9-12 Years)
n=16 Participants
Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in "Split Dose" method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.
"Day Before" method was the alternative method if "Split Dose" was not appropriate. In "Day Before" method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.
The dose was ½ sachet for this subset of participants (9-12 years old).
|
Prepopik® 1 Sachet x 2 (9-12 Years)
n=16 Participants
Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in "Split Dose" method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.
"Day Before" method was the alternative method if "Split Dose" was not appropriate. In "Day Before" method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.
The dose was 1 sachet for this subset of participants (9-12 years old).
|
Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years)
n=16 Participants
Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (9-12 years old).
|
Prepopik® 1 Sachet x 2 (13-16 Years)
n=16 Participants
Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in "Split Dose" method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.
"Day Before" method was the alternative method if "Split Dose" was not appropriate. In "Day Before" method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.
The dose was 1 sachet for this subset of participants (13-16 years old).
|
Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years)
n=14 Participants
Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (13-16 years old).
|
|---|---|---|---|---|---|
|
Percentage of Participants Defined by "Excellent" or "Good" in the Aronchick Scale
|
50 percentage of participants
Interval 27.9 to 72.1
|
87.5 percentage of participants
Interval 65.6 to 97.7
|
81.3 percentage of participants
Interval 58.3 to 94.7
|
81.3 percentage of participants
Interval 58.3 to 94.7
|
85.7 percentage of participants
Interval 61.5 to 97.4
|
SECONDARY outcome
Timeframe: Up to 33 days after colonoscopyPopulation: The safety analysis set included participants who received at least one dose of the trial medication. Participants were analyzed according to actual treatment received. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
An adverse event (AE) is defined as any untoward medical occurrence in a participant taking part in a clinical trial. Proportion of participants with AE are presented.
Outcome measures
| Measure |
Prepopik® ½ Sachet x 2 (9-12 Years)
n=15 Participants
Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in "Split Dose" method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.
"Day Before" method was the alternative method if "Split Dose" was not appropriate. In "Day Before" method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.
The dose was ½ sachet for this subset of participants (9-12 years old).
|
Prepopik® 1 Sachet x 2 (9-12 Years)
n=17 Participants
Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in "Split Dose" method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.
"Day Before" method was the alternative method if "Split Dose" was not appropriate. In "Day Before" method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.
The dose was 1 sachet for this subset of participants (9-12 years old).
|
Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years)
n=15 Participants
Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (9-12 years old).
|
Prepopik® 1 Sachet x 2 (13-16 Years)
n=16 Participants
Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in "Split Dose" method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.
"Day Before" method was the alternative method if "Split Dose" was not appropriate. In "Day Before" method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.
The dose was 1 sachet for this subset of participants (13-16 years old).
|
Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years)
n=12 Participants
Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (13-16 years old).
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
|
8 participants
|
5 participants
|
6 participants
|
10 participants
|
11 participants
|
SECONDARY outcome
Timeframe: From up to 42 days prior to colonoscopy, at the day of colonoscopy, and up to 7 days post colonoscopyPopulation: The safety analysis set included participants who received at least one dose of the trial medication. Participants were analyzed according to actual treatment received. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
Proportion of participants with abnormal findings in laboratory tests are presented.
Outcome measures
| Measure |
Prepopik® ½ Sachet x 2 (9-12 Years)
n=15 Participants
Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in "Split Dose" method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.
"Day Before" method was the alternative method if "Split Dose" was not appropriate. In "Day Before" method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.
The dose was ½ sachet for this subset of participants (9-12 years old).
|
Prepopik® 1 Sachet x 2 (9-12 Years)
n=17 Participants
Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in "Split Dose" method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.
"Day Before" method was the alternative method if "Split Dose" was not appropriate. In "Day Before" method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.
The dose was 1 sachet for this subset of participants (9-12 years old).
|
Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years)
n=15 Participants
Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (9-12 years old).
|
Prepopik® 1 Sachet x 2 (13-16 Years)
n=16 Participants
Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in "Split Dose" method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.
"Day Before" method was the alternative method if "Split Dose" was not appropriate. In "Day Before" method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.
The dose was 1 sachet for this subset of participants (13-16 years old).
|
Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years)
n=12 Participants
Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (13-16 years old).
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Findings in Laboratory Tests
Basophils (ratio) ≥upper limit (≥1)
|
2 participants
|
2 participants
|
4 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Abnormal Findings in Laboratory Tests
Eosinophils (ratio) ≥upper limit (≥5)
|
4 participants
|
1 participants
|
3 participants
|
2 participants
|
1 participants
|
|
Number of Participants With Abnormal Findings in Laboratory Tests
Erythrocytes (×10^12/L)≤ lower limit(≤3.5×10^12/L)
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormal Findings in Laboratory Tests
Leukocytes (×10^9/L) ≤lower limit (≤4×10^9/L)
|
1 participants
|
2 participants
|
1 participants
|
1 participants
|
2 participants
|
|
Number of Participants With Abnormal Findings in Laboratory Tests
Lymphocytes (×10^9/L) ≤lower limit (≤1×10^9/L)
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Abnormal Findings in Laboratory Tests
Monocytes (ratio) ≥upper limit (≥5)
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Abnormal Findings in Laboratory Tests
Neutrophils (×10^9/L) ≥upper limit (≥10×10^9/L)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Abnormal Findings in Laboratory Tests
Bilirubin (μmol/L) ≥upper limit (≥34 μmol/L)
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormal Findings in Laboratory Tests
Glucose (mmol/L) ≤lower limit (≤2.8 mmol/L)
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Abnormal Findings in Laboratory Tests
Protein (g/L) ≥upper limit (≥80 g/L)
|
2 participants
|
1 participants
|
0 participants
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: From up to 42 days prior to colonoscopy, on the day of randomization, and at the day of colonoscopyPopulation: The safety analysis set included participants who received at least one dose of the trial medication. Participants were analyzed according to actual treatment received. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
Complete physical examination was conducted at screening and directed physical examinations at other time-points. Directed physical examinations are presented.
Outcome measures
| Measure |
Prepopik® ½ Sachet x 2 (9-12 Years)
n=15 Participants
Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in "Split Dose" method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.
"Day Before" method was the alternative method if "Split Dose" was not appropriate. In "Day Before" method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.
The dose was ½ sachet for this subset of participants (9-12 years old).
|
Prepopik® 1 Sachet x 2 (9-12 Years)
n=17 Participants
Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in "Split Dose" method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.
"Day Before" method was the alternative method if "Split Dose" was not appropriate. In "Day Before" method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.
The dose was 1 sachet for this subset of participants (9-12 years old).
|
Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years)
n=15 Participants
Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (9-12 years old).
|
Prepopik® 1 Sachet x 2 (13-16 Years)
n=16 Participants
Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in "Split Dose" method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.
"Day Before" method was the alternative method if "Split Dose" was not appropriate. In "Day Before" method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.
The dose was 1 sachet for this subset of participants (13-16 years old).
|
Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years)
n=12 Participants
Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (13-16 years old).
|
|---|---|---|---|---|---|
|
Number of Participants With Abnormal Findings in Physical Examination
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Approx. 1 day (From the day before colonoscopy to the day of colonoscopy)Population: The safety analysis set included participants who received at least one dose of the trial medication. Participants were analyzed according to actual treatment received. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
The proportion of participants who took the assigned dose of Prepopik® was assessed.
Outcome measures
| Measure |
Prepopik® ½ Sachet x 2 (9-12 Years)
n=15 Participants
Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in "Split Dose" method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.
"Day Before" method was the alternative method if "Split Dose" was not appropriate. In "Day Before" method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.
The dose was ½ sachet for this subset of participants (9-12 years old).
|
Prepopik® 1 Sachet x 2 (9-12 Years)
n=17 Participants
Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in "Split Dose" method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.
"Day Before" method was the alternative method if "Split Dose" was not appropriate. In "Day Before" method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.
The dose was 1 sachet for this subset of participants (9-12 years old).
|
Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years)
n=15 Participants
Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (9-12 years old).
|
Prepopik® 1 Sachet x 2 (13-16 Years)
n=16 Participants
Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in "Split Dose" method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.
"Day Before" method was the alternative method if "Split Dose" was not appropriate. In "Day Before" method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.
The dose was 1 sachet for this subset of participants (13-16 years old).
|
Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years)
n=12 Participants
Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (13-16 years old).
|
|---|---|---|---|---|---|
|
Number of Participants Who Took the Assigned Dose for Colon Cleansing
Was dose 1 taken?
|
15 participants
|
17 participants
|
15 participants
|
16 participants
|
12 participants
|
|
Number of Participants Who Took the Assigned Dose for Colon Cleansing
Was dose 2 taken?
|
14 participants
|
17 participants
|
3 participants
|
15 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 1 day of colonoscopyPopulation: The secondary efficacy analysis was based on the ITT analysis set, which included all participants who were randomized.
Subject's Tolerability and Satisfaction Questionnaire consists of three questions. Question (Q)1 was "How easy was it to drink the bowel cleanout medicine?" and Q2 was "How did the bowel cleanout medicine taste?". Q3 had five subparts namely: 1. "How often did your tummy hurt since you started the medicine?" and 2. "How often did you feel fullness in your tummy, since you started the cleanout?" and 3. "How often did you wake up last night" and 4. "How often did you feel sick to your stomach (nausea) since you started the cleanout?' and 5. "How much were you bothered by going to the washroom since you started the cleanout?" Satisfactory was defined as a response of 1 (Very Easy) or 2 (Easy) on Q1 and a response of 1 (Very Well) or 2 (Well) on Q2. Tolerable was defined as a response of 1 (Never) or 2 (Rarely) to the five subparts specified in Q3.
Outcome measures
| Measure |
Prepopik® ½ Sachet x 2 (9-12 Years)
n=16 Participants
Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in "Split Dose" method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.
"Day Before" method was the alternative method if "Split Dose" was not appropriate. In "Day Before" method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.
The dose was ½ sachet for this subset of participants (9-12 years old).
|
Prepopik® 1 Sachet x 2 (9-12 Years)
n=16 Participants
Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in "Split Dose" method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.
"Day Before" method was the alternative method if "Split Dose" was not appropriate. In "Day Before" method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.
The dose was 1 sachet for this subset of participants (9-12 years old).
|
Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years)
n=16 Participants
Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (9-12 years old).
|
Prepopik® 1 Sachet x 2 (13-16 Years)
n=16 Participants
Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in "Split Dose" method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.
"Day Before" method was the alternative method if "Split Dose" was not appropriate. In "Day Before" method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.
The dose was 1 sachet for this subset of participants (13-16 years old).
|
Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years)
n=14 Participants
Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (13-16 years old).
|
|---|---|---|---|---|---|
|
Number of Participants in Each Category of the "Subject's Tolerability and Satisfaction Questionaire"
Q1-Satisfactory
|
9 participants
|
6 participants
|
2 participants
|
8 participants
|
4 participants
|
|
Number of Participants in Each Category of the "Subject's Tolerability and Satisfaction Questionaire"
Q2-Satisfactory
|
4 participants
|
1 participants
|
5 participants
|
3 participants
|
2 participants
|
|
Number of Participants in Each Category of the "Subject's Tolerability and Satisfaction Questionaire"
Q3-Subpart 1-Tolerable
|
4 participants
|
9 participants
|
2 participants
|
4 participants
|
5 participants
|
|
Number of Participants in Each Category of the "Subject's Tolerability and Satisfaction Questionaire"
Q3-Subpart 2-Tolerable
|
9 participants
|
8 participants
|
8 participants
|
7 participants
|
4 participants
|
|
Number of Participants in Each Category of the "Subject's Tolerability and Satisfaction Questionaire"
Q3-Subpart 3-Tolerable
|
10 participants
|
12 participants
|
11 participants
|
7 participants
|
8 participants
|
|
Number of Participants in Each Category of the "Subject's Tolerability and Satisfaction Questionaire"
Q3-Subpart 4-Tolerable
|
7 participants
|
9 participants
|
7 participants
|
8 participants
|
3 participants
|
|
Number of Participants in Each Category of the "Subject's Tolerability and Satisfaction Questionaire"
Q3-Subpart 5-Tolerable
|
9 participants
|
7 participants
|
2 participants
|
5 participants
|
2 participants
|
Adverse Events
Prepopik® ½ Sachet x 2 (9-12 Years)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Prepopik® 1 Sachet x 2 (9-12 Years)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Prepopik® 1 Sachet x 2 (13-16 Years)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Prepopik® ½ Sachet x 2 (9-12 Years)
n=15 participants at risk
Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in "Split Dose" method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.
"Day Before" method was the alternative method if "Split Dose" was not appropriate. In "Day Before" method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.
The dose was ½ sachet for this subset of participants (9-12 years old).
|
Prepopik® 1 Sachet x 2 (9-12 Years)
n=17 participants at risk
Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in "Split Dose" method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.
"Day Before" method was the alternative method if "Split Dose" was not appropriate. In "Day Before" method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.
The dose was 1 sachet for this subset of participants (9-12 years old).
|
Oral Polyethylene Glycol (PEG) Based Preparation (9-12 Years)
n=15 participants at risk
Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (9-12 years old).
|
Prepopik® 1 Sachet x 2 (13-16 Years)
n=16 participants at risk
Prepopik® (sodium picosulfate 10 mg; magnesium oxide 3.5 g and anhydrous citric acid 12 g) reconstituted with water was administered in "Split Dose" method. The first dose was administered between 5:00 PM and 9:00 PM on the day before the colonoscopy procedure. The second dose was given on the next day, at least 6 hours after the first dose and approximately 5 hours before but no more than 9 hours prior to the colonoscopy.
"Day Before" method was the alternative method if "Split Dose" was not appropriate. In "Day Before" method, the first dose was administered during the afternoon or early evening before the colonoscopy and the second dose was administered 6 hours later during the evening before the colonoscopy.
The dose was 1 sachet for this subset of participants (13-16 years old).
|
Oral Polyethylene Glycol (PEG) Based Preparation (13-16 Years)
n=12 participants at risk
Oral PEG based preparation/ local standard of care following appropriate label and/or institutional instructions for this subset of participants (13-16 years old).
|
|---|---|---|---|---|---|
|
Investigations
Neutrophil count increased
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/17 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/16 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
8.3%
1/12 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/17 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
6.2%
1/16 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/12 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/17 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/16 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
8.3%
1/12 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Eye disorders
Conjunctival hemmorrhage
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/17 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
6.2%
1/16 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/12 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Gastrointestinal disorders
Nausea
|
13.3%
2/15 • Number of events 2 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
5.9%
1/17 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
6.7%
1/15 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
6.2%
1/16 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
25.0%
3/12 • Number of events 3 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
3/15 • Number of events 3 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/17 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
12.5%
2/16 • Number of events 2 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
8.3%
1/12 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
5.9%
1/17 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
6.2%
1/16 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/12 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Gastrointestinal disorders
Crohn's disease
|
6.7%
1/15 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/17 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
6.7%
1/15 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/16 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/12 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/17 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
6.2%
1/16 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
8.3%
1/12 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Gastrointestinal disorders
Hematochezia
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
5.9%
1/17 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
6.2%
1/16 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/12 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/17 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
6.7%
1/15 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
6.2%
1/16 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/12 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Gastrointestinal disorders
Esophagitis
|
6.7%
1/15 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/17 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
6.2%
1/16 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/12 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/17 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
6.7%
1/15 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/16 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/12 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
5.9%
1/17 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/16 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/12 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Gastrointestinal disorders
Colitis microscopic
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/17 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/16 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
8.3%
1/12 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Gastrointestinal disorders
Constipation
|
6.7%
1/15 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/17 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/16 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/12 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Gastrointestinal disorders
Eosinophilic colitis
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/17 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
6.2%
1/16 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/12 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
5.9%
1/17 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/16 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/12 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Gastrointestinal disorders
Gastroenteritis eosinophilic
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/17 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
6.2%
1/16 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/12 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Gastrointestinal disorders
Gastrointestinal mucosa hyperemia
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/17 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
6.2%
1/16 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/12 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Gastrointestinal disorders
Inflammatory bowel disease
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/17 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
6.7%
1/15 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/16 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/12 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Gastrointestinal disorders
Intestinal ulcer
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/17 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
6.2%
1/16 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/12 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Gastrointestinal disorders
Large intestinal ulcer
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/17 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
6.2%
1/16 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/12 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
5.9%
1/17 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/16 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/12 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/17 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
6.2%
1/16 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/12 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
General disorders
Chest pain
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/17 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
6.7%
1/15 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/16 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/12 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
General disorders
Pyrexia
|
6.7%
1/15 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/17 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/16 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/12 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Infections and infestations
Foot and mouth disease
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
5.9%
1/17 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/16 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/12 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/17 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/16 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
8.3%
1/12 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Infections and infestations
Esophageal candidiasis
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/17 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/16 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
8.3%
1/12 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
5.9%
1/17 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/16 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/12 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/17 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
6.7%
1/15 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/16 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/12 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
5.9%
1/17 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/16 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/12 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
5.9%
1/17 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/16 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/12 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Investigations
White blood cells urine positive
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/17 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
6.7%
1/15 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
6.2%
1/16 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
8.3%
1/12 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Investigations
White blood cell count increased
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/17 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
6.2%
1/16 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
8.3%
1/12 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/17 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
6.2%
1/16 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/12 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Investigations
Hematocrit decreased
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/17 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/16 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
8.3%
1/12 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Investigations
Hemoglobin decreased
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/17 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/16 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
8.3%
1/12 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Investigations
Platelet count increased
|
6.7%
1/15 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/17 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/16 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/12 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/17 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
6.7%
1/15 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/16 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/12 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Investigations
Urine bilirubin increased
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/17 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/16 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
8.3%
1/12 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Investigations
White blood cell count decreased
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
5.9%
1/17 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/16 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/12 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Metabolism and nutrition disorders
Lactose intolerance
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/17 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
6.2%
1/16 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/12 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
6.7%
1/15 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/17 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/16 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/12 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/17 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/16 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
8.3%
1/12 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Nervous system disorders
Headache
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/17 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/16 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
8.3%
1/12 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Nervous system disorders
Lethargy
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
5.9%
1/17 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/16 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/12 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Nervous system disorders
Migraine
|
6.7%
1/15 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/17 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/16 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/12 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/17 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
6.7%
1/15 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
6.2%
1/16 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
8.3%
1/12 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/17 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/16 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
16.7%
2/12 • Number of events 2 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/17 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
6.2%
1/16 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/12 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
|
Vascular disorders
Hypertension
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/17 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/15 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
6.2%
1/16 • Number of events 1 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
0.00%
0/12 • AEs were reported and recorded at Visits 2 (day of randomization) through 5 (Day 28 after the colonoscopy procedure).
Treatment-emergent AE defined as any AE that began during the treatment period (i.e., period during which a participant received an investigational medicinal product) or there was a worsening of a pre-existing medical condition are presented. The results are presented for the safety analysis set. One of the participant randomized to Prepopik® ½ sachet x 2 (9-12 years) received Prepopik® 1 sachet x 2 (9-12 years) instead (n=17).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review the draft manuscript prior to publication and can request delay of publication where any contents are deemed patentable by the sponsor or confidential to the sponsor. Comments will be given within four weeks from receipt of the draft manuscript. Additional time may be required to allow Ferring to seek patent protection of the invention.
- Publication restrictions are in place
Restriction type: OTHER