Trial Outcomes & Findings for Efficacy and Safety of mAnnitol in Bowel Preparation During Elective Colonoscopy and Comparison With Moviprep® (NCT NCT04759885)
NCT ID: NCT04759885
Last Updated: 2025-12-08
Results Overview
Proportion of patients with adequate bowel cleansing, defined as BBPS total score ≥ 6, with a score for each of the three colon segments ≥ 2 during colonoscopy after standard washing and air insufflation for luminal distension. The mannitol dose to be used in phase III was singled out on an algorithm that calculated a total score for each dose starting from the scores assigned to the three main criteria through a ranking system and proportionally to the importance given to each main criterion: A - rate of adequate bowel cleansing (most important - primary endpoint), B - rate of patients in safe conditions and C - clinical judgement score (least important - partially based on subjective assessments).
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
886 participants
Primary outcome timeframe
During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed
Results posted on
2025-12-08
Participant Flow
Study period: * Phase II study initiation date: 22 June 2020 * Phase II LPLV: 12 November 2020 * Phase III study initiation date: 2 March 2021 * Phase III LPLV: 16 July 2021 * Phase II: 6 centres in Italy, 2 centres in Germany and 1 centre in France * Phase III: 32 centres located in Italy, Germany, France, and Russia
Phase II Planned sample size n.150; screened patients n.199; screen failures n.16; randomized patients n.183; completed patients: 179 Phase III Planned sample size n.696; screened patients n. 841; withdrawal patients n. 7; screen failures n. 131; randomized patients n.703; completed patients: 683
Participant milestones
| Measure |
Phase II: NTC015 Low Dose
Mannitol 50 g administered as single dose
|
Phase II: NTC015 Medium Dose
Mannitol 100 g administered as single dose
|
Phase II: NTC015 High Dose
Mannitol 150 g administered as single dose
|
Phase III: NTC015 Selected Dose
Mannitol 100 g selected from phase II, single dose
|
Phase III: 2L PEG ASC (Moviprep®)
2 L polyethylene glycol plus ascorbate solution, split-dose regimen
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
66
|
57
|
60
|
352
|
351
|
|
Overall Study
COMPLETED
|
65
|
57
|
57
|
338
|
345
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
3
|
14
|
6
|
Reasons for withdrawal
| Measure |
Phase II: NTC015 Low Dose
Mannitol 50 g administered as single dose
|
Phase II: NTC015 Medium Dose
Mannitol 100 g administered as single dose
|
Phase II: NTC015 High Dose
Mannitol 150 g administered as single dose
|
Phase III: NTC015 Selected Dose
Mannitol 100 g selected from phase II, single dose
|
Phase III: 2L PEG ASC (Moviprep®)
2 L polyethylene glycol plus ascorbate solution, split-dose regimen
|
|---|---|---|---|---|---|
|
Overall Study
Other
|
1
|
0
|
2
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
9
|
6
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
3
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
2
|
0
|
Baseline Characteristics
Percentages were computed on female patients belonging to the PP Population.
Baseline characteristics by cohort
| Measure |
Phase II: NTC015 Low Dose
n=66 Participants
Mannitol 50 g administered as single dose
|
Phase II: NTC015 Medium Dose
n=57 Participants
Mannitol 100 g administered as single dose
|
Phase II: NTC015 High Dose
n=60 Participants
Mannitol 150 g administered as single dose
|
Phase III: NTC015 Selected Dose
n=352 Participants
Mannitol 100 g selected from phase II, single dose
|
Phase III: 2L PEG ASC (Moviprep®)
n=351 Participants
2 L polyethylene glycol plus ascorbate solution, split dose
|
Total
n=886 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
Age at study entry
|
57.55 years
STANDARD_DEVIATION 11.15 • n=66 Participants
|
54.4 years
STANDARD_DEVIATION 11.19 • n=57 Participants
|
53.8 years
STANDARD_DEVIATION 13.78 • n=60 Participants
|
54.8 years
STANDARD_DEVIATION 12.65 • n=352 Participants
|
54.6 years
STANDARD_DEVIATION 12.71 • n=351 Participants
|
54.7 years
STANDARD_DEVIATION 12.67 • n=886 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=66 Participants
|
32 Participants
n=57 Participants
|
36 Participants
n=60 Participants
|
219 Participants
n=352 Participants
|
196 Participants
n=351 Participants
|
513 Participants
n=886 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=66 Participants
|
25 Participants
n=57 Participants
|
24 Participants
n=60 Participants
|
133 Participants
n=352 Participants
|
155 Participants
n=351 Participants
|
373 Participants
n=886 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=66 Participants
|
0 Participants
n=57 Participants
|
3 Participants
n=60 Participants
|
4 Participants
n=352 Participants
|
4 Participants
n=351 Participants
|
13 Participants
n=886 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
63 Participants
n=66 Participants
|
54 Participants
n=57 Participants
|
56 Participants
n=60 Participants
|
343 Participants
n=352 Participants
|
344 Participants
n=351 Participants
|
860 Participants
n=886 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=66 Participants
|
3 Participants
n=57 Participants
|
1 Participants
n=60 Participants
|
5 Participants
n=352 Participants
|
3 Participants
n=351 Participants
|
13 Participants
n=886 Participants
|
|
Female reproductive status
Childbearing potential
|
8 Participants
n=30 Participants • Percentages were computed on female patients belonging to the PP Population.
|
6 Participants
n=32 Participants • Percentages were computed on female patients belonging to the PP Population.
|
15 Participants
n=36 Participants • Percentages were computed on female patients belonging to the PP Population.
|
103 Participants
n=219 Participants • Percentages were computed on female patients belonging to the PP Population.
|
100 Participants
n=196 Participants • Percentages were computed on female patients belonging to the PP Population.
|
232 Participants
n=513 Participants • Percentages were computed on female patients belonging to the PP Population.
|
|
Female reproductive status
Menopause
|
20 Participants
n=30 Participants • Percentages were computed on female patients belonging to the PP Population.
|
23 Participants
n=32 Participants • Percentages were computed on female patients belonging to the PP Population.
|
21 Participants
n=36 Participants • Percentages were computed on female patients belonging to the PP Population.
|
106 Participants
n=219 Participants • Percentages were computed on female patients belonging to the PP Population.
|
87 Participants
n=196 Participants • Percentages were computed on female patients belonging to the PP Population.
|
257 Participants
n=513 Participants • Percentages were computed on female patients belonging to the PP Population.
|
|
Female reproductive status
Sterile
|
2 Participants
n=30 Participants • Percentages were computed on female patients belonging to the PP Population.
|
3 Participants
n=32 Participants • Percentages were computed on female patients belonging to the PP Population.
|
0 Participants
n=36 Participants • Percentages were computed on female patients belonging to the PP Population.
|
9 Participants
n=219 Participants • Percentages were computed on female patients belonging to the PP Population.
|
8 Participants
n=196 Participants • Percentages were computed on female patients belonging to the PP Population.
|
22 Participants
n=513 Participants • Percentages were computed on female patients belonging to the PP Population.
|
|
Female reproductive status
Other
|
0 Participants
n=30 Participants • Percentages were computed on female patients belonging to the PP Population.
|
0 Participants
n=32 Participants • Percentages were computed on female patients belonging to the PP Population.
|
0 Participants
n=36 Participants • Percentages were computed on female patients belonging to the PP Population.
|
1 Participants
n=219 Participants • Percentages were computed on female patients belonging to the PP Population.
|
1 Participants
n=196 Participants • Percentages were computed on female patients belonging to the PP Population.
|
2 Participants
n=513 Participants • Percentages were computed on female patients belonging to the PP Population.
|
PRIMARY outcome
Timeframe: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performedPopulation: Percentages were computed on patients belonging to the PP population.
Proportion of patients with adequate bowel cleansing, defined as BBPS total score ≥ 6, with a score for each of the three colon segments ≥ 2 during colonoscopy after standard washing and air insufflation for luminal distension. The mannitol dose to be used in phase III was singled out on an algorithm that calculated a total score for each dose starting from the scores assigned to the three main criteria through a ranking system and proportionally to the importance given to each main criterion: A - rate of adequate bowel cleansing (most important - primary endpoint), B - rate of patients in safe conditions and C - clinical judgement score (least important - partially based on subjective assessments).
Outcome measures
| Measure |
Phase II: NTC015 Medium Dose
n=54 Participants
Mannitol 100 g administered as single dose
|
Phase II: NTC015 High Dose
n=49 Participants
Mannitol 150 g administered as single dose
|
Phase III: NTC015 Selected Dose
n=60 Participants
Mannitol 100 g selected in phase II, single dose
|
|---|---|---|---|
|
Phase II - Dose Finding: Proportion of Patients With Adequate Bowel Cleansing
|
0.94 Proportion of patients
Interval 0.88 to 1.0
|
0.94 Proportion of patients
Interval 0.87 to 1.0
|
0.75 Proportion of patients
Interval 0.64 to 0.86
|
PRIMARY outcome
Timeframe: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed, at least 4 hours after end of intake, following product instruction as per protocolPopulation: Percentages were computed on patients belonging to the PP Population.
Proportion of patients with adequate bowel cleansing, defined as BBPS total score ≥ 6, with a score for each of the three colon segments (right; transverse, including flexures; and left, including sigmoid and rectum) ≥ 2 during colonoscopy after standard washing and air insufflation for luminal distension.
Outcome measures
| Measure |
Phase II: NTC015 Medium Dose
n=332 Participants
Mannitol 100 g administered as single dose
|
Phase II: NTC015 High Dose
Mannitol 150 g administered as single dose
|
Phase III: NTC015 Selected Dose
n=325 Participants
Mannitol 100 g selected in phase II, single dose
|
|---|---|---|---|
|
Phase III - Non-inferiority: Proportion of Patients With Adequate Bowel Cleansing
|
0.95 Proportion of patients
Interval 0.93 to 0.98
|
—
|
0.91 Proportion of patients
Interval 0.88 to 0.94
|
SECONDARY outcome
Timeframe: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performedPopulation: Percentages were computed on patients belonging to the PP population.
The percentage of patients with appendiceal orifice visible to the endoscopist. Evaluation will be performed during conduction of colonoscopy run on visit 4. Timing for treatment administration was described in the protocol and change among arms.
Outcome measures
| Measure |
Phase II: NTC015 Medium Dose
n=54 Participants
Mannitol 100 g administered as single dose
|
Phase II: NTC015 High Dose
n=49 Participants
Mannitol 150 g administered as single dose
|
Phase III: NTC015 Selected Dose
n=60 Participants
Mannitol 100 g selected in phase II, single dose
|
|---|---|---|---|
|
Phase II - Dose Finding: Caecal Intubation Rate
|
1 Proportion of patients
Interval 1.0 to 1.0
|
1 Proportion of patients
Interval 1.0 to 1.0
|
0.92 Proportion of patients
Interval 0.85 to 0.99
|
SECONDARY outcome
Timeframe: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed, 4 hours after the end of study drug self-administration, before colonoscopyPopulation: Percentages were computed on patients belonging to the PP population. Overall Number of Participants Analyzed referred to patient that completely taken assigned mannitol dose.
Proportion of patient that completely taken assigned mannitol dose.
Outcome measures
| Measure |
Phase II: NTC015 Medium Dose
n=54 Participants
Mannitol 100 g administered as single dose
|
Phase II: NTC015 High Dose
n=49 Participants
Mannitol 150 g administered as single dose
|
Phase III: NTC015 Selected Dose
n=60 Participants
Mannitol 100 g selected in phase II, single dose
|
|---|---|---|---|
|
Phase II - Dose Finding: Adherence to Bowel Preparation
|
54 Participants
|
49 Participants
|
60 Participants
|
SECONDARY outcome
Timeframe: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed. 4 hours after the end of study drug self-administration, before colonoscopy (please refer to protocol)Population: Percentages were computed on patients belonging to the PP population.
Descriptive statistics (Mean) of Numeric Rating Scale (NRS) values ranging from 0 (very difficult) to 10 (very easy).
Outcome measures
| Measure |
Phase II: NTC015 Medium Dose
n=54 Participants
Mannitol 100 g administered as single dose
|
Phase II: NTC015 High Dose
n=49 Participants
Mannitol 150 g administered as single dose
|
Phase III: NTC015 Selected Dose
n=60 Participants
Mannitol 100 g selected in phase II, single dose
|
|---|---|---|---|
|
Phase II - Dose Finding: Ease of Use
|
9.3 Score
Standard Deviation 1.09
|
9.1 Score
Standard Deviation 1.36
|
9.6 Score
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed. 4 hours after the end of study drug self-administration, before colonoscopyPopulation: Percentages were computed on patients belonging to the PP population.
Proportion of patient who confirmed that they would like to reuse the preparation for other colonoscopies.
Outcome measures
| Measure |
Phase II: NTC015 Medium Dose
n=54 Participants
Mannitol 100 g administered as single dose
|
Phase II: NTC015 High Dose
n=49 Participants
Mannitol 150 g administered as single dose
|
Phase III: NTC015 Selected Dose
n=60 Participants
Mannitol 100 g selected in phase II, single dose
|
|---|---|---|---|
|
Phase II - Dose Finding: Willingness to Reuse the Preparation
Yes
|
51 Participants
|
46 Participants
|
60 Participants
|
|
Phase II - Dose Finding: Willingness to Reuse the Preparation
No
|
3 Participants
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed. 4 hours after the end of study drug self-administration, before colonoscopyPopulation: Percentages were computed on patients belonging to the PP population.
Descriptive statistics (Mean) of Numeric Rating Scale (NRS) values ranging from 0 (terrible) to 10 (very good).
Outcome measures
| Measure |
Phase II: NTC015 Medium Dose
n=54 Participants
Mannitol 100 g administered as single dose
|
Phase II: NTC015 High Dose
n=49 Participants
Mannitol 150 g administered as single dose
|
Phase III: NTC015 Selected Dose
n=60 Participants
Mannitol 100 g selected in phase II, single dose
|
|---|---|---|---|
|
Phase II - Dose Finding: Treatment Acceptability
|
8.3 score on a scale
Standard Deviation 1.49
|
8.0 score on a scale
Standard Deviation 1.94
|
9.2 score on a scale
Standard Deviation 1.01
|
SECONDARY outcome
Timeframe: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed. Before mannitol self-administration and 8 hours (T8) after completion of mannitol self-administrationPopulation: Percentages were computed on patients belonging to the PK population.
descriptive statistics (mean) of peak plasma concentration (Cmax) as pharmacokinetic parameter.
Outcome measures
| Measure |
Phase II: NTC015 Medium Dose
n=11 Participants
Mannitol 100 g administered as single dose
|
Phase II: NTC015 High Dose
n=17 Participants
Mannitol 150 g administered as single dose
|
Phase III: NTC015 Selected Dose
n=15 Participants
Mannitol 100 g selected in phase II, single dose
|
|---|---|---|---|
|
Phase II - Pharmacokinetic Parameter: Peak Plasma Concentration
|
1.0236 Mannitol plasma concentrations (mg/mL)
Standard Deviation 0.27877
|
1.3729 Mannitol plasma concentrations (mg/mL)
Standard Deviation 0.38338
|
0.6304 Mannitol plasma concentrations (mg/mL)
Standard Deviation 0.14536
|
SECONDARY outcome
Timeframe: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed. Before mannitol self-administration and 8 hours (T8) after completion of mannitol self-administrationPopulation: Percentages were computed on patients belonging to the PK population.
Descriptive statistics (Median) of time to maximum concentration (tmax) as pharmacokinetic parameter.
Outcome measures
| Measure |
Phase II: NTC015 Medium Dose
n=11 Participants
Mannitol 100 g administered as single dose
|
Phase II: NTC015 High Dose
n=17 Participants
Mannitol 150 g administered as single dose
|
Phase III: NTC015 Selected Dose
n=15 Participants
Mannitol 100 g selected in phase II, single dose
|
|---|---|---|---|
|
Phase II - Pharmacokinetic Parameter: Time to Maximum Concentration
|
1.3636 Hours
Standard Deviation 0.52259
|
1.4488 Hours
Standard Deviation 0.80422
|
1.1173 Hours
Standard Deviation 0.36110
|
SECONDARY outcome
Timeframe: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed. Before mannitol self-administration and 8 hours (T8) after completion of mannitol self-administrationPopulation: Percentages were computed on patients belonging to the PK population.
Descriptive statistics (Mean) of area under the curve from t0 to the last blood sampling time point (AUC 0-t8), as pharmacokinetic parameter.
Outcome measures
| Measure |
Phase II: NTC015 Medium Dose
n=11 Participants
Mannitol 100 g administered as single dose
|
Phase II: NTC015 High Dose
n=17 Participants
Mannitol 150 g administered as single dose
|
Phase III: NTC015 Selected Dose
n=15 Participants
Mannitol 100 g selected in phase II, single dose
|
|---|---|---|---|
|
Phase II - Pharmacokinetic Parameter: Area Under the Curve
|
4.1591 mg/mL*hours
Standard Deviation 1.34820
|
5.8476 mg/mL*hours
Standard Deviation 2.36432
|
2.2313 mg/mL*hours
Standard Deviation 0.52086
|
SECONDARY outcome
Timeframe: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed. Before mannitol self-administration and 8 hours (T8) after completion of mannitol self-administrationPopulation: Percentages were computed on patients belonging to the PK population.
Descriptive statistics (Mean) of elimination half life (t1/2), as pharmacokinetic parameter.
Outcome measures
| Measure |
Phase II: NTC015 Medium Dose
n=7 Participants
Mannitol 100 g administered as single dose
|
Phase II: NTC015 High Dose
n=11 Participants
Mannitol 150 g administered as single dose
|
Phase III: NTC015 Selected Dose
n=13 Participants
Mannitol 100 g selected in phase II, single dose
|
|---|---|---|---|
|
Phase II - Pharmacokinetic Parameter: Terminal Elimination Half Life
|
2.4186 Hours
Standard Deviation 0.57883
|
2.6782 Hours
Standard Deviation 0.48912
|
2.5838 Hours
Standard Deviation 0.83985
|
SECONDARY outcome
Timeframe: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performedPopulation: Percentages were computed on patients belonging to the Full Analysis Set.
The percentage of patients with at least one lesion detected.
Outcome measures
| Measure |
Phase II: NTC015 Medium Dose
n=347 Participants
Mannitol 100 g administered as single dose
|
Phase II: NTC015 High Dose
Mannitol 150 g administered as single dose
|
Phase III: NTC015 Selected Dose
n=333 Participants
Mannitol 100 g selected in phase II, single dose
|
|---|---|---|---|
|
Phase III - Non-inferiority: Adenoma Detection Rate
Adenoma detection rate - Yes
|
103 Number of patients
|
—
|
98 Number of patients
|
|
Phase III - Non-inferiority: Adenoma Detection Rate
Adenoma detection rate - No
|
244 Number of patients
|
—
|
235 Number of patients
|
SECONDARY outcome
Timeframe: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performedPopulation: Percentages were computed on patients belonging to the Full Analysis Set.
Ottawa scale is used to measure the quality of the preparation in three different parts of the colon before washing and insufflation. descriptive statistics (Mean) of the total score (from 0 excellent to 14 inadequate).
Outcome measures
| Measure |
Phase II: NTC015 Medium Dose
n=347 Participants
Mannitol 100 g administered as single dose
|
Phase II: NTC015 High Dose
Mannitol 150 g administered as single dose
|
Phase III: NTC015 Selected Dose
n=332 Participants
Mannitol 100 g selected in phase II, single dose
|
|---|---|---|---|
|
Phase III - Non-inferiority: Ottawa Bowel Preparation Scale (OBPS)
|
3.6 score on a scale
Standard Deviation 2.52
|
—
|
4.4 score on a scale
Standard Deviation 3.08
|
SECONDARY outcome
Timeframe: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performedPopulation: Percentages were computed on patients belonging to the Full Analysis Set.
The percentage of patients with appendiceal orifice visible to the endoscopist.
Outcome measures
| Measure |
Phase II: NTC015 Medium Dose
n=347 Participants
Mannitol 100 g administered as single dose
|
Phase II: NTC015 High Dose
Mannitol 150 g administered as single dose
|
Phase III: NTC015 Selected Dose
n=333 Participants
Mannitol 100 g selected in phase II, single dose
|
|---|---|---|---|
|
Phase III - Non-inferiority: Caecal Intubation Rate
Yes
|
345 Participants
|
—
|
327 Participants
|
|
Phase III - Non-inferiority: Caecal Intubation Rate
No
|
2 Participants
|
—
|
6 Participants
|
SECONDARY outcome
Timeframe: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed. After the end of study drug self-administration, before colonoscopyPopulation: Percentages were computed on patients belonging to Italian centers in the Safety set.
The BOCLIR is a questionnaire filled in by patients to measure the acceptability and tolerability of bowel cleansers consisting of three unidimensional scales (satisfaction, symptoms and activity limitations) with good psychometric and scaling properties. Item responses are summed to provide a score for each scale and a total score. The satisfaction scale contains eight items and the score ranges from 0 (highly satisfied) to 32 (highly dissatisfied). The symptoms scale includes 14 items and the score ranges from 0 (no symptoms) to 42 (severe symptoms). The activity limitations scale is made up of 12 items and the score ranges from 0 (no effect on activities) to 36 (activities greatly affected). The total score is the sum of the three scales and ranges from 0 to 110. Patients who report a worse experience in terms of the three factors score higher on the BOCLIR scale.
Outcome measures
| Measure |
Phase II: NTC015 Medium Dose
n=240 Participants
Mannitol 100 g administered as single dose
|
Phase II: NTC015 High Dose
Mannitol 150 g administered as single dose
|
Phase III: NTC015 Selected Dose
n=236 Participants
Mannitol 100 g selected in phase II, single dose
|
|---|---|---|---|
|
Phase III - Non-inferiority: Bowel Cleansing Impact Review (BOCLIR) (Italian Sites Only)
|
31.5 score on a scale
Standard Deviation 16.26
|
—
|
23.5 score on a scale
Standard Deviation 13.48
|
SECONDARY outcome
Timeframe: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed. 4 hours after the end of study drug self-administration, before colonoscopyPopulation: Percentages were computed on patients belonging to the Safety set who have been administered questionnaire on adherence and acceptability.
Proportion of patients that completely taken, partially taken or not taken assigned mannitol dose
Outcome measures
| Measure |
Phase II: NTC015 Medium Dose
n=347 Participants
Mannitol 100 g administered as single dose
|
Phase II: NTC015 High Dose
Mannitol 150 g administered as single dose
|
Phase III: NTC015 Selected Dose
n=341 Participants
Mannitol 100 g selected in phase II, single dose
|
|---|---|---|---|
|
Phase III - Non-inferiority: Adherence to Bowel Preparation With Mannitol and With Moviprep®.
Completely taken (fully drinked)
|
341 Number of patients
|
—
|
341 Number of patients
|
|
Phase III - Non-inferiority: Adherence to Bowel Preparation With Mannitol and With Moviprep®.
Partially taken
|
6 Number of patients
|
—
|
0 Number of patients
|
SECONDARY outcome
Timeframe: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed. 4 hours after the end of study drug self-administration, before colonoscopyPopulation: Percentages were computed on patients belonging to the Safety set.
Descriptive statistics (Mean) of Numeric Rating Scale (NRS) values ranging from 0 (very difficult) to 10 (very easy).
Outcome measures
| Measure |
Phase II: NTC015 Medium Dose
n=347 Participants
Mannitol 100 g administered as single dose
|
Phase II: NTC015 High Dose
Mannitol 150 g administered as single dose
|
Phase III: NTC015 Selected Dose
n=341 Participants
Mannitol 100 g selected in phase II, single dose
|
|---|---|---|---|
|
Phase III - Non-inferiority: Ease of Use
|
8.5 score on a scale
Standard Deviation 2.00
|
—
|
9.3 score on a scale
Standard Deviation 1.41
|
SECONDARY outcome
Timeframe: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed. 4 hours after the end of study drug self-administration, before colonoscopyPopulation: Percentages were computed on patients belonging to the Safety set who have been administered questionnaire on adherence and ac ceptability.
Proportion of patient who confirmed that they would like to reuse the preparation for other colonoscopies.
Outcome measures
| Measure |
Phase II: NTC015 Medium Dose
n=347 Participants
Mannitol 100 g administered as single dose
|
Phase II: NTC015 High Dose
Mannitol 150 g administered as single dose
|
Phase III: NTC015 Selected Dose
n=341 Participants
Mannitol 100 g selected in phase II, single dose
|
|---|---|---|---|
|
Phase III - Non-inferiority: Willingness to Reuse the Preparation
Yes
|
272 Participants
|
—
|
331 Participants
|
|
Phase III - Non-inferiority: Willingness to Reuse the Preparation
No
|
75 Participants
|
—
|
10 Participants
|
SECONDARY outcome
Timeframe: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed. 4 hours after the end of study drug self-administration, before colonoscopyPopulation: Percentages were computed on patients belonging to the Safety set.
Descriptive statistics (Mean) of Numeric Rating Scale (NRS) values ranging from 0 (terrible) to 10 (very good).
Outcome measures
| Measure |
Phase II: NTC015 Medium Dose
n=347 Participants
Mannitol 100 g administered as single dose
|
Phase II: NTC015 High Dose
Mannitol 150 g administered as single dose
|
Phase III: NTC015 Selected Dose
n=341 Participants
Mannitol 100 g selected in phase II, single dose
|
|---|---|---|---|
|
Phase III - Non-inferiority: Treatment Acceptability
|
5.6 score on a scale
Standard Deviation 2.67
|
—
|
8.3 score on a scale
Standard Deviation 1.74
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed after standard washing and air insufflation for luminal distensionPopulation: Percentages were computed on patients belonging to the PP population evaluable for potentially dangerous levels of H2 and CH4
Proportion of patients in safe condition for intestinal gases defined as concentration of potentially critical concentrations of gases (H2\>4% and CH4 \>5%)
Outcome measures
| Measure |
Phase II: NTC015 Medium Dose
n=54 Participants
Mannitol 100 g administered as single dose
|
Phase II: NTC015 High Dose
n=49 Participants
Mannitol 150 g administered as single dose
|
Phase III: NTC015 Selected Dose
n=60 Participants
Mannitol 100 g selected in phase II, single dose
|
|---|---|---|---|
|
Phase II - Dose Finding: Patients in Safe Condition Related to Potentially Critical Concentrations of Gases (H2/CH4)
Proportion of patients with potentially dangerous levels of H2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase II - Dose Finding: Patients in Safe Condition Related to Potentially Critical Concentrations of Gases (H2/CH4)
Proportion of patients with potentially dangerous levels of CH4
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 2 (≤ 7 days before Visit 4), Visit 3 (≤ 7 days before Visit 4) and Visit 4 (during the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed)Population: Percentages were computed on patients belonging to the Safety set.
Incidence of adverse events occuring starting from enrollment
Outcome measures
| Measure |
Phase II: NTC015 Medium Dose
n=57 Participants
Mannitol 100 g administered as single dose
|
Phase II: NTC015 High Dose
n=57 Participants
Mannitol 150 g administered as single dose
|
Phase III: NTC015 Selected Dose
n=65 Participants
Mannitol 100 g selected in phase II, single dose
|
|---|---|---|---|
|
Phase II - Dose Finding: Incidence of Adverse Events
Patients with at least one TEAE
|
11 Participants
|
19 Participants
|
7 Participants
|
|
Phase II - Dose Finding: Incidence of Adverse Events
Patients with at least one TESAE
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Phase II - Dose Finding: Incidence of Adverse Events
Patients with at least one TEAE related to study drug
|
6 Participants
|
12 Participants
|
2 Participants
|
|
Phase II - Dose Finding: Incidence of Adverse Events
Patients with at least one TESAE related to study drug
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase II - Dose Finding: Incidence of Adverse Events
Patients with at least one TESAE related to colonoscopy
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase II - Dose Finding: Incidence of Adverse Events
Patients with at least one AESI
|
7 Participants
|
11 Participants
|
1 Participants
|
|
Phase II - Dose Finding: Incidence of Adverse Events
Patients with at least one TEAE leading to study drug withdrawal
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Phase II - Dose Finding: Incidence of Adverse Events
Patients with at least one TESAE leading to colonoscopy interruption
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase II - Dose Finding: Incidence of Adverse Events
Patients with at least one fatal TESAE
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Phase II - Dose Finding: Incidence of Adverse Events
Patients with at least one TEAE related to colonoscopy
|
1 Participants
|
2 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed. 4 hours and 8 hours after completion of study drug self administrationPopulation: Percentages were computed on patients belonging to the Safety set.
Proportion of patients with change from baseline considered clinically significant by the Investigator of haematological and chemical parameters (CBC, creatinine, BUN, eGFR, ALT, AST, glucose, electrolytes) 4 hours and 8 hours after completion of study drug self-administration.
Outcome measures
| Measure |
Phase II: NTC015 Medium Dose
n=57 Participants
Mannitol 100 g administered as single dose
|
Phase II: NTC015 High Dose
n=57 Participants
Mannitol 150 g administered as single dose
|
Phase III: NTC015 Selected Dose
n=65 Participants
Mannitol 100 g selected in phase II, single dose
|
|---|---|---|---|
|
Phase II - Dose Finding: Proportion of Patients With Clinically Significant Change of Haematological and Chemical Parameters From Baseline
Patients with at least one clinically significant abnormality (chemical parameters)
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Phase II - Dose Finding: Proportion of Patients With Clinically Significant Change of Haematological and Chemical Parameters From Baseline
Patients with at least one clinically significant abnormality (hematological parameters)
|
0 Participants
|
2 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performedProportion of patients with change of vital signs during colonoscopy considered clinically significant by the Investigator (heart rate and pulse oximetry).
Outcome measures
| Measure |
Phase II: NTC015 Medium Dose
n=57 Participants
Mannitol 100 g administered as single dose
|
Phase II: NTC015 High Dose
n=57 Participants
Mannitol 150 g administered as single dose
|
Phase III: NTC015 Selected Dose
n=65 Participants
Mannitol 100 g selected in phase II, single dose
|
|---|---|---|---|
|
Phase II - Dose Finding: Proportion of Patients With Clinically Significant Change of Vital Signs During Colonoscopy
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performedPopulation: Percentages were computed on patients belonging to the safety set evaluable for potentially dangerous levels of H2 and CH4. Some patients were excluded from the analysis because their gas concentrations were measured through a device with malfunction issues
Proportion of patients in safe condition for intestinal gases defined as concentration of potentially critical concentration of gases (H2\>4% and CH4 \>5%)
Outcome measures
| Measure |
Phase II: NTC015 Medium Dose
n=342 Participants
Mannitol 100 g administered as single dose
|
Phase II: NTC015 High Dose
Mannitol 150 g administered as single dose
|
Phase III: NTC015 Selected Dose
n=331 Participants
Mannitol 100 g selected in phase II, single dose
|
|---|---|---|---|
|
Phase III - Dose Finding:Patients in Safe Condition Related to Potentially Critical Concentration of Gases (H2/CH4)
Proportion of patients with potentually dangerous levels H2
|
0 Participants
|
—
|
0 Participants
|
|
Phase III - Dose Finding:Patients in Safe Condition Related to Potentially Critical Concentration of Gases (H2/CH4)
Proportion of patients with potentually dangerous levels CH4
|
0 Participants
|
—
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 2 (≤ 7 days before Visit 4), Visit 3 (≤ 7 days before Visit 4) and Visit 4 (during the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed)Population: Percentages were computed on patients belonging to the Safety set.
Incidence of adverse events occuring starting from enrollment
Outcome measures
| Measure |
Phase II: NTC015 Medium Dose
n=347 Participants
Mannitol 100 g administered as single dose
|
Phase II: NTC015 High Dose
Mannitol 150 g administered as single dose
|
Phase III: NTC015 Selected Dose
n=343 Participants
Mannitol 100 g selected in phase II, single dose
|
|---|---|---|---|
|
Phase III - Non-inferiority: Incidence of Adverse Events
Patients with at least one TEAE
|
36 Participants
|
—
|
52 Participants
|
|
Phase III - Non-inferiority: Incidence of Adverse Events
Patients with at least one TESAE
|
0 Participants
|
—
|
3 Participants
|
|
Phase III - Non-inferiority: Incidence of Adverse Events
Patients with at least one TEAE related to study drug
|
14 Participants
|
—
|
32 Participants
|
|
Phase III - Non-inferiority: Incidence of Adverse Events
Patients with at least one TEAE related to study drug leading to study drug withdrawal
|
1 Participants
|
—
|
1 Participants
|
|
Phase III - Non-inferiority: Incidence of Adverse Events
Patients with at least one TESAE related to study drug leading to study drug withdrawal
|
0 Participants
|
—
|
0 Participants
|
|
Phase III - Non-inferiority: Incidence of Adverse Events
Patients with at least one TEAE related to colonoscopy
|
2 Participants
|
—
|
5 Participants
|
|
Phase III - Non-inferiority: Incidence of Adverse Events
Patients with at least one TESAE related to colonoscopy
|
0 Participants
|
—
|
0 Participants
|
|
Phase III - Non-inferiority: Incidence of Adverse Events
Patients with at least one TEAE leading to study drug withdrawal
|
1 Participants
|
—
|
1 Participants
|
|
Phase III - Non-inferiority: Incidence of Adverse Events
Patients with at least one TESAE related to study drug
|
0 Participants
|
—
|
3 Participants
|
|
Phase III - Non-inferiority: Incidence of Adverse Events
Patients with at least one TEAE leading to colonoscopy interruption
|
1 Participants
|
—
|
1 Participants
|
|
Phase III - Non-inferiority: Incidence of Adverse Events
Patients with at least one fatal TESAE
|
0 Participants
|
—
|
0 Participants
|
|
Phase III - Non-inferiority: Incidence of Adverse Events
Patients with at least one treatment-emergent AESI
|
9 Participants
|
—
|
27 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed. 4 hours and 8 hours after completion of study drug self-administrationPopulation: Percentages were computed on patients belonging to the Safety set.
Proportion of patients with change from baseline considered clinically significant by the Investigator of haematological and chemical parameters (CBC, creatinine, BUN, eGFR, ALT, AST, glucose, electrolytes) 4 hours and 8 hours after completion of study drug self-administration.
Outcome measures
| Measure |
Phase II: NTC015 Medium Dose
n=347 Participants
Mannitol 100 g administered as single dose
|
Phase II: NTC015 High Dose
Mannitol 150 g administered as single dose
|
Phase III: NTC015 Selected Dose
n=343 Participants
Mannitol 100 g selected in phase II, single dose
|
|---|---|---|---|
|
Phase III - Non-inferiority: Proportion of Patients With Clinically Significant Change of Haematological and Chemical Parameters From Baseline
Patients with at least one clinically significant abnormality (Clinical chemistry)
|
5 Participants
|
—
|
12 Participants
|
|
Phase III - Non-inferiority: Proportion of Patients With Clinically Significant Change of Haematological and Chemical Parameters From Baseline
Patients with at least one clinically significant abnormality (Hematology)
|
0 Participants
|
—
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During the colonoscopy procedure, carried out within 7 days of the screening visit, the evaluation is performed, prior to colonoscopyPopulation: Percentages were computed on patients belonging to the Safety set.
Proportion of patients with change of vital signs from baseline considered clinically significant by the Investigator (heart rate, systolic and diastolic blood pressure), as well as clinically significant change during colonoscopy of pulse oximetry, systolic and diastolic blood pressure and heart rate.
Outcome measures
| Measure |
Phase II: NTC015 Medium Dose
n=347 Participants
Mannitol 100 g administered as single dose
|
Phase II: NTC015 High Dose
Mannitol 150 g administered as single dose
|
Phase III: NTC015 Selected Dose
n=343 Participants
Mannitol 100 g selected in phase II, single dose
|
|---|---|---|---|
|
Phase III - Non-inferiority: Proportion of Patients With Change of Vital Signs From Baseline and During Colonoscopy
|
1 Participants
|
—
|
2 Participants
|
Adverse Events
Phase II: NTC015 Low Dose
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase II: NTC015 Medium Dose
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Phase II: NTC015 High Dose
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Phase III: NTC015 Selected Dose
Serious events: 3 serious events
Other events: 25 other events
Deaths: 0 deaths
Phase III:2 L PEG ASC (Moviprep®)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase II: NTC015 Low Dose
n=65 participants at risk
Mannitol 50 g administered as single dose
|
Phase II: NTC015 Medium Dose
n=57 participants at risk
Mannitol 100 g administered as single dose
|
Phase II: NTC015 High Dose
n=57 participants at risk
Mannitol 150 g administered as single dose
|
Phase III: NTC015 Selected Dose
n=343 participants at risk
Mannitol 100g selected from phae II, single dose
|
Phase III:2 L PEG ASC (Moviprep®)
n=347 participants at risk
2 L polyethylene glycol plus ascorbate solution, split dose
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.00%
0/65 • Phase II and III: Adverse events where monitored during 4 visits of the study: from signature of the informed consent form up to and including the day of colonoscopy, up to 4 weeks (i.e., day in which patient performed the last assessment planned in the study protocol and thus complete the study). After the drug intake adverse event was checked during day of colonoscopy. In case of serious adverse event the clinical situation was monitored until resolution
|
0.00%
0/57 • Phase II and III: Adverse events where monitored during 4 visits of the study: from signature of the informed consent form up to and including the day of colonoscopy, up to 4 weeks (i.e., day in which patient performed the last assessment planned in the study protocol and thus complete the study). After the drug intake adverse event was checked during day of colonoscopy. In case of serious adverse event the clinical situation was monitored until resolution
|
0.00%
0/57 • Phase II and III: Adverse events where monitored during 4 visits of the study: from signature of the informed consent form up to and including the day of colonoscopy, up to 4 weeks (i.e., day in which patient performed the last assessment planned in the study protocol and thus complete the study). After the drug intake adverse event was checked during day of colonoscopy. In case of serious adverse event the clinical situation was monitored until resolution
|
0.29%
1/343 • Phase II and III: Adverse events where monitored during 4 visits of the study: from signature of the informed consent form up to and including the day of colonoscopy, up to 4 weeks (i.e., day in which patient performed the last assessment planned in the study protocol and thus complete the study). After the drug intake adverse event was checked during day of colonoscopy. In case of serious adverse event the clinical situation was monitored until resolution
|
0.00%
0/347 • Phase II and III: Adverse events where monitored during 4 visits of the study: from signature of the informed consent form up to and including the day of colonoscopy, up to 4 weeks (i.e., day in which patient performed the last assessment planned in the study protocol and thus complete the study). After the drug intake adverse event was checked during day of colonoscopy. In case of serious adverse event the clinical situation was monitored until resolution
|
|
Nervous system disorders
Presyncope
|
0.00%
0/65 • Phase II and III: Adverse events where monitored during 4 visits of the study: from signature of the informed consent form up to and including the day of colonoscopy, up to 4 weeks (i.e., day in which patient performed the last assessment planned in the study protocol and thus complete the study). After the drug intake adverse event was checked during day of colonoscopy. In case of serious adverse event the clinical situation was monitored until resolution
|
0.00%
0/57 • Phase II and III: Adverse events where monitored during 4 visits of the study: from signature of the informed consent form up to and including the day of colonoscopy, up to 4 weeks (i.e., day in which patient performed the last assessment planned in the study protocol and thus complete the study). After the drug intake adverse event was checked during day of colonoscopy. In case of serious adverse event the clinical situation was monitored until resolution
|
1.8%
1/57 • Phase II and III: Adverse events where monitored during 4 visits of the study: from signature of the informed consent form up to and including the day of colonoscopy, up to 4 weeks (i.e., day in which patient performed the last assessment planned in the study protocol and thus complete the study). After the drug intake adverse event was checked during day of colonoscopy. In case of serious adverse event the clinical situation was monitored until resolution
|
0.29%
1/343 • Phase II and III: Adverse events where monitored during 4 visits of the study: from signature of the informed consent form up to and including the day of colonoscopy, up to 4 weeks (i.e., day in which patient performed the last assessment planned in the study protocol and thus complete the study). After the drug intake adverse event was checked during day of colonoscopy. In case of serious adverse event the clinical situation was monitored until resolution
|
0.00%
0/347 • Phase II and III: Adverse events where monitored during 4 visits of the study: from signature of the informed consent form up to and including the day of colonoscopy, up to 4 weeks (i.e., day in which patient performed the last assessment planned in the study protocol and thus complete the study). After the drug intake adverse event was checked during day of colonoscopy. In case of serious adverse event the clinical situation was monitored until resolution
|
|
Nervous system disorders
Syncope
|
0.00%
0/65 • Phase II and III: Adverse events where monitored during 4 visits of the study: from signature of the informed consent form up to and including the day of colonoscopy, up to 4 weeks (i.e., day in which patient performed the last assessment planned in the study protocol and thus complete the study). After the drug intake adverse event was checked during day of colonoscopy. In case of serious adverse event the clinical situation was monitored until resolution
|
0.00%
0/57 • Phase II and III: Adverse events where monitored during 4 visits of the study: from signature of the informed consent form up to and including the day of colonoscopy, up to 4 weeks (i.e., day in which patient performed the last assessment planned in the study protocol and thus complete the study). After the drug intake adverse event was checked during day of colonoscopy. In case of serious adverse event the clinical situation was monitored until resolution
|
1.8%
1/57 • Phase II and III: Adverse events where monitored during 4 visits of the study: from signature of the informed consent form up to and including the day of colonoscopy, up to 4 weeks (i.e., day in which patient performed the last assessment planned in the study protocol and thus complete the study). After the drug intake adverse event was checked during day of colonoscopy. In case of serious adverse event the clinical situation was monitored until resolution
|
0.29%
1/343 • Phase II and III: Adverse events where monitored during 4 visits of the study: from signature of the informed consent form up to and including the day of colonoscopy, up to 4 weeks (i.e., day in which patient performed the last assessment planned in the study protocol and thus complete the study). After the drug intake adverse event was checked during day of colonoscopy. In case of serious adverse event the clinical situation was monitored until resolution
|
0.00%
0/347 • Phase II and III: Adverse events where monitored during 4 visits of the study: from signature of the informed consent form up to and including the day of colonoscopy, up to 4 weeks (i.e., day in which patient performed the last assessment planned in the study protocol and thus complete the study). After the drug intake adverse event was checked during day of colonoscopy. In case of serious adverse event the clinical situation was monitored until resolution
|
Other adverse events
| Measure |
Phase II: NTC015 Low Dose
n=65 participants at risk
Mannitol 50 g administered as single dose
|
Phase II: NTC015 Medium Dose
n=57 participants at risk
Mannitol 100 g administered as single dose
|
Phase II: NTC015 High Dose
n=57 participants at risk
Mannitol 150 g administered as single dose
|
Phase III: NTC015 Selected Dose
n=343 participants at risk
Mannitol 100g selected from phae II, single dose
|
Phase III:2 L PEG ASC (Moviprep®)
n=347 participants at risk
2 L polyethylene glycol plus ascorbate solution, split dose
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
diverticulum intestinal
|
3.1%
2/65 • Number of events 2 • Phase II and III: Adverse events where monitored during 4 visits of the study: from signature of the informed consent form up to and including the day of colonoscopy, up to 4 weeks (i.e., day in which patient performed the last assessment planned in the study protocol and thus complete the study). After the drug intake adverse event was checked during day of colonoscopy. In case of serious adverse event the clinical situation was monitored until resolution
|
1.8%
1/57 • Number of events 1 • Phase II and III: Adverse events where monitored during 4 visits of the study: from signature of the informed consent form up to and including the day of colonoscopy, up to 4 weeks (i.e., day in which patient performed the last assessment planned in the study protocol and thus complete the study). After the drug intake adverse event was checked during day of colonoscopy. In case of serious adverse event the clinical situation was monitored until resolution
|
7.0%
4/57 • Number of events 4 • Phase II and III: Adverse events where monitored during 4 visits of the study: from signature of the informed consent form up to and including the day of colonoscopy, up to 4 weeks (i.e., day in which patient performed the last assessment planned in the study protocol and thus complete the study). After the drug intake adverse event was checked during day of colonoscopy. In case of serious adverse event the clinical situation was monitored until resolution
|
0.29%
1/343 • Number of events 1 • Phase II and III: Adverse events where monitored during 4 visits of the study: from signature of the informed consent form up to and including the day of colonoscopy, up to 4 weeks (i.e., day in which patient performed the last assessment planned in the study protocol and thus complete the study). After the drug intake adverse event was checked during day of colonoscopy. In case of serious adverse event the clinical situation was monitored until resolution
|
0.58%
2/347 • Number of events 2 • Phase II and III: Adverse events where monitored during 4 visits of the study: from signature of the informed consent form up to and including the day of colonoscopy, up to 4 weeks (i.e., day in which patient performed the last assessment planned in the study protocol and thus complete the study). After the drug intake adverse event was checked during day of colonoscopy. In case of serious adverse event the clinical situation was monitored until resolution
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
1/65 • Number of events 1 • Phase II and III: Adverse events where monitored during 4 visits of the study: from signature of the informed consent form up to and including the day of colonoscopy, up to 4 weeks (i.e., day in which patient performed the last assessment planned in the study protocol and thus complete the study). After the drug intake adverse event was checked during day of colonoscopy. In case of serious adverse event the clinical situation was monitored until resolution
|
5.3%
3/57 • Number of events 3 • Phase II and III: Adverse events where monitored during 4 visits of the study: from signature of the informed consent form up to and including the day of colonoscopy, up to 4 weeks (i.e., day in which patient performed the last assessment planned in the study protocol and thus complete the study). After the drug intake adverse event was checked during day of colonoscopy. In case of serious adverse event the clinical situation was monitored until resolution
|
14.0%
8/57 • Number of events 8 • Phase II and III: Adverse events where monitored during 4 visits of the study: from signature of the informed consent form up to and including the day of colonoscopy, up to 4 weeks (i.e., day in which patient performed the last assessment planned in the study protocol and thus complete the study). After the drug intake adverse event was checked during day of colonoscopy. In case of serious adverse event the clinical situation was monitored until resolution
|
4.4%
15/343 • Number of events 15 • Phase II and III: Adverse events where monitored during 4 visits of the study: from signature of the informed consent form up to and including the day of colonoscopy, up to 4 weeks (i.e., day in which patient performed the last assessment planned in the study protocol and thus complete the study). After the drug intake adverse event was checked during day of colonoscopy. In case of serious adverse event the clinical situation was monitored until resolution
|
0.58%
2/347 • Number of events 2 • Phase II and III: Adverse events where monitored during 4 visits of the study: from signature of the informed consent form up to and including the day of colonoscopy, up to 4 weeks (i.e., day in which patient performed the last assessment planned in the study protocol and thus complete the study). After the drug intake adverse event was checked during day of colonoscopy. In case of serious adverse event the clinical situation was monitored until resolution
|
|
Gastrointestinal disorders
large intestinal polyp
|
0.00%
0/65 • Phase II and III: Adverse events where monitored during 4 visits of the study: from signature of the informed consent form up to and including the day of colonoscopy, up to 4 weeks (i.e., day in which patient performed the last assessment planned in the study protocol and thus complete the study). After the drug intake adverse event was checked during day of colonoscopy. In case of serious adverse event the clinical situation was monitored until resolution
|
1.8%
1/57 • Number of events 1 • Phase II and III: Adverse events where monitored during 4 visits of the study: from signature of the informed consent form up to and including the day of colonoscopy, up to 4 weeks (i.e., day in which patient performed the last assessment planned in the study protocol and thus complete the study). After the drug intake adverse event was checked during day of colonoscopy. In case of serious adverse event the clinical situation was monitored until resolution
|
5.3%
3/57 • Number of events 3 • Phase II and III: Adverse events where monitored during 4 visits of the study: from signature of the informed consent form up to and including the day of colonoscopy, up to 4 weeks (i.e., day in which patient performed the last assessment planned in the study protocol and thus complete the study). After the drug intake adverse event was checked during day of colonoscopy. In case of serious adverse event the clinical situation was monitored until resolution
|
0.00%
0/343 • Phase II and III: Adverse events where monitored during 4 visits of the study: from signature of the informed consent form up to and including the day of colonoscopy, up to 4 weeks (i.e., day in which patient performed the last assessment planned in the study protocol and thus complete the study). After the drug intake adverse event was checked during day of colonoscopy. In case of serious adverse event the clinical situation was monitored until resolution
|
0.00%
0/347 • Phase II and III: Adverse events where monitored during 4 visits of the study: from signature of the informed consent form up to and including the day of colonoscopy, up to 4 weeks (i.e., day in which patient performed the last assessment planned in the study protocol and thus complete the study). After the drug intake adverse event was checked during day of colonoscopy. In case of serious adverse event the clinical situation was monitored until resolution
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/65 • Phase II and III: Adverse events where monitored during 4 visits of the study: from signature of the informed consent form up to and including the day of colonoscopy, up to 4 weeks (i.e., day in which patient performed the last assessment planned in the study protocol and thus complete the study). After the drug intake adverse event was checked during day of colonoscopy. In case of serious adverse event the clinical situation was monitored until resolution
|
7.0%
4/57 • Number of events 4 • Phase II and III: Adverse events where monitored during 4 visits of the study: from signature of the informed consent form up to and including the day of colonoscopy, up to 4 weeks (i.e., day in which patient performed the last assessment planned in the study protocol and thus complete the study). After the drug intake adverse event was checked during day of colonoscopy. In case of serious adverse event the clinical situation was monitored until resolution
|
5.3%
3/57 • Number of events 3 • Phase II and III: Adverse events where monitored during 4 visits of the study: from signature of the informed consent form up to and including the day of colonoscopy, up to 4 weeks (i.e., day in which patient performed the last assessment planned in the study protocol and thus complete the study). After the drug intake adverse event was checked during day of colonoscopy. In case of serious adverse event the clinical situation was monitored until resolution
|
2.9%
10/343 • Number of events 10 • Phase II and III: Adverse events where monitored during 4 visits of the study: from signature of the informed consent form up to and including the day of colonoscopy, up to 4 weeks (i.e., day in which patient performed the last assessment planned in the study protocol and thus complete the study). After the drug intake adverse event was checked during day of colonoscopy. In case of serious adverse event the clinical situation was monitored until resolution
|
1.7%
6/347 • Number of events 6 • Phase II and III: Adverse events where monitored during 4 visits of the study: from signature of the informed consent form up to and including the day of colonoscopy, up to 4 weeks (i.e., day in which patient performed the last assessment planned in the study protocol and thus complete the study). After the drug intake adverse event was checked during day of colonoscopy. In case of serious adverse event the clinical situation was monitored until resolution
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place