Trial Outcomes & Findings for Efficacy, Safety and Tolerability of Eziclen®/Izinova® Versus Klean-prep® on Bowel Cleansing in Adolescents Undergoing Colonoscopy (NCT NCT03008460)
NCT ID: NCT03008460
Last Updated: 2021-03-02
Results Overview
Blinded overall assessment of preparation efficacy (Cleansing Score) was determined by the colonoscopist upon completion of the examination, based on a 4-point scale as follows: * 4 (Excellent) = No more than small bits of adherent faeces/fluid * 3 (Good) = Small amounts of faeces or fluid not interfering with examination * 2 (Fair) = Enough faeces or fluid to prevent a completely reliable examination * 1 (Poor) = Large amounts of faecal residue, additional cleansing required. Only perfect preparations graded as excellent (4) or good (3), which allowed full, reliable examination of the mucosa were considered as successful. The adjusted percentage of subjects with a successful preparation was determined using a logistic regression model, including treatment and country as covariates.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
250 participants
Primary outcome timeframe
At Day 2 (colonoscopy visit)
Results posted on
2021-03-02
Participant Flow
This study was conducted in adolescents (aged 12 to 17 years inclusive) who were undergoing a colonoscopy for a routinely accepted diagnostic indication. Subjects were randomised 1:1 to Eziclen®/Izinova® (¾ of adult dose; 750 millilitres \[mL\] of preparation plus 1500 mL of water) or Klean-Prep® (70 mL/kilogram \[kg\]; maximum of 4000 mL). Subjects were randomised at 22 study centres in 6 countries.
The study consisted of a 1-day enrolment (Day 1, baseline) and investigator-blind label dosing period, a colonoscopy (Day 2) and a 30-day follow-up period (Day 32 \[-5/+15, i.e. Day 27 to Day 47\]). Subjects were expected to participate in the study for a minimum of 27 days and up to 47 days.
Participant milestones
| Measure |
Eziclen®/Izinova®
Subjects received Eziclen®/Izinova® oral sulphate salt solution, administered as ¾ of the adult dose, as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The 750 mL preparation was administered in 2 half doses as follows: the first half of preparation (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Approximately 2 hours after starting the first half of preparation, the second half (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Overall total volume (preparation + water) was 2250 mL (1125 mL per dose).
|
Klean-Prep®
Subjects received Klean-Prep® oral solution, administered as a 70 mL/kg dose (calculated based on subject's weight) as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The whole solution was administered in 2 half doses (1 litre per hour), with a 1-hour pause between the 2 half doses. Approximately 2 hours after starting the first half of preparation, the second half was drunk. The maximum global volume administered was 4000 mL (2000 mL per dose).
|
|---|---|---|
|
Overall Study
STARTED
|
126
|
124
|
|
Overall Study
COMPLETED
|
119
|
110
|
|
Overall Study
NOT COMPLETED
|
7
|
14
|
Reasons for withdrawal
| Measure |
Eziclen®/Izinova®
Subjects received Eziclen®/Izinova® oral sulphate salt solution, administered as ¾ of the adult dose, as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The 750 mL preparation was administered in 2 half doses as follows: the first half of preparation (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Approximately 2 hours after starting the first half of preparation, the second half (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Overall total volume (preparation + water) was 2250 mL (1125 mL per dose).
|
Klean-Prep®
Subjects received Klean-Prep® oral solution, administered as a 70 mL/kg dose (calculated based on subject's weight) as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The whole solution was administered in 2 half doses (1 litre per hour), with a 1-hour pause between the 2 half doses. Approximately 2 hours after starting the first half of preparation, the second half was drunk. The maximum global volume administered was 4000 mL (2000 mL per dose).
|
|---|---|---|
|
Overall Study
Protocol deviation
|
0
|
2
|
|
Overall Study
Study drug not dispensed
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
6
|
|
Overall Study
COVID-19 pandemic - consent withdrawn
|
1
|
0
|
|
Overall Study
End of study visit outside permitted time window
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Eziclen®/Izinova®
n=125 Participants
Subjects received Eziclen®/Izinova® oral sulphate salt solution, administered as ¾ of the adult dose, as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The 750 mL preparation was administered in 2 half doses as follows: the first half of preparation (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Approximately 2 hours after starting the first half of preparation, the second half (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Overall total volume (preparation + water) was 2250 mL (1125 mL per dose).
|
Klean-Prep®
n=116 Participants
Subjects received Klean-Prep® oral solution, administered as a 70 mL/kg dose (calculated based on subject's weight) as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The whole solution was administered in 2 half doses (1 litre per hour), with a 1-hour pause between the 2 half doses. Approximately 2 hours after starting the first half of preparation, the second half was drunk. The maximum global volume administered was 4000 mL (2000 mL per dose).
|
Total
n=241 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15.1 years
STANDARD_DEVIATION 1.6 • n=125 Participants
|
15.3 years
STANDARD_DEVIATION 1.6 • n=116 Participants
|
15.2 years
STANDARD_DEVIATION 1.6 • n=241 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=125 Participants
|
47 Participants
n=116 Participants
|
107 Participants
n=241 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=125 Participants
|
69 Participants
n=116 Participants
|
134 Participants
n=241 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
France
|
9 participants
n=125 Participants
|
9 participants
n=116 Participants
|
18 participants
n=241 Participants
|
|
Region of Enrollment
Germany
|
13 participants
n=125 Participants
|
11 participants
n=116 Participants
|
24 participants
n=241 Participants
|
|
Region of Enrollment
Italy
|
10 participants
n=125 Participants
|
8 participants
n=116 Participants
|
18 participants
n=241 Participants
|
|
Region of Enrollment
Netherlands
|
20 participants
n=125 Participants
|
20 participants
n=116 Participants
|
40 participants
n=241 Participants
|
|
Region of Enrollment
Poland
|
70 participants
n=125 Participants
|
65 participants
n=116 Participants
|
135 participants
n=241 Participants
|
|
Region of Enrollment
Czechia
|
3 participants
n=125 Participants
|
3 participants
n=116 Participants
|
6 participants
n=241 Participants
|
PRIMARY outcome
Timeframe: At Day 2 (colonoscopy visit)Population: The modified intention-to-treat population included all randomised subjects who received even a partial dose of study drug and produced a primary efficacy assessment.
Blinded overall assessment of preparation efficacy (Cleansing Score) was determined by the colonoscopist upon completion of the examination, based on a 4-point scale as follows: * 4 (Excellent) = No more than small bits of adherent faeces/fluid * 3 (Good) = Small amounts of faeces or fluid not interfering with examination * 2 (Fair) = Enough faeces or fluid to prevent a completely reliable examination * 1 (Poor) = Large amounts of faecal residue, additional cleansing required. Only perfect preparations graded as excellent (4) or good (3), which allowed full, reliable examination of the mucosa were considered as successful. The adjusted percentage of subjects with a successful preparation was determined using a logistic regression model, including treatment and country as covariates.
Outcome measures
| Measure |
Eziclen®/Izinova®
n=125 Participants
Subjects received Eziclen®/Izinova® oral sulphate salt solution, administered as ¾ of the adult dose, as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The 750 mL preparation was administered in 2 half doses as follows: the first half of preparation (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Approximately 2 hours after starting the first half of preparation, the second half (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Overall total volume (preparation + water) was 2250 mL (1125 mL per dose).
|
Klean-Prep®
n=116 Participants
Subjects received Klean-Prep® oral solution, administered as a 70 mL/kg dose (calculated based on subject's weight) as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The whole solution was administered in 2 half doses (1 litre per hour), with a 1-hour pause between the 2 half doses. Approximately 2 hours after starting the first half of preparation, the second half was drunk. The maximum global volume administered was 4000 mL (2000 mL per dose).
|
|---|---|---|
|
Percentage of Subjects With Successful Overall Colon Preparation, Assessed With the Cleansing Score (4-point Scale)
|
71.42 adjusted percentage of subjects
Interval 56.33 to 82.89
|
79.03 adjusted percentage of subjects
Interval 65.34 to 88.28
|
SECONDARY outcome
Timeframe: At Day 2 (colonoscopy visit)Population: The ITT population included all randomised subjects who received even a partial dose of study drug.
The Cleansing Score was determined by the blinded colonoscopist, based on a 4-point scale as follows: * 4 (Excellent) = No more than small bits of adherent faeces/fluid * 3 (Good) = Small amounts of faeces or fluid not interfering with examination * 2 (Fair) = Enough faeces or fluid to prevent a completely reliable examination * 1 (Poor) = Large amounts of faecal residue, additional cleansing required. The adjusted mean score was estimated using a 2-way analysis of variance (ANOVA), including treatment and country as covariates.
Outcome measures
| Measure |
Eziclen®/Izinova®
n=125 Participants
Subjects received Eziclen®/Izinova® oral sulphate salt solution, administered as ¾ of the adult dose, as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The 750 mL preparation was administered in 2 half doses as follows: the first half of preparation (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Approximately 2 hours after starting the first half of preparation, the second half (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Overall total volume (preparation + water) was 2250 mL (1125 mL per dose).
|
Klean-Prep®
n=116 Participants
Subjects received Klean-Prep® oral solution, administered as a 70 mL/kg dose (calculated based on subject's weight) as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The whole solution was administered in 2 half doses (1 litre per hour), with a 1-hour pause between the 2 half doses. Approximately 2 hours after starting the first half of preparation, the second half was drunk. The maximum global volume administered was 4000 mL (2000 mL per dose).
|
|---|---|---|
|
Mean Colon Cleansing Score (4-point Scale)
|
2.83 scores on a scale
Interval 2.67 to 2.99
|
3.02 scores on a scale
Interval 2.85 to 3.18
|
SECONDARY outcome
Timeframe: At Day 2 (colonoscopy visit)Population: The ITT population included all randomised subjects who received even a partial dose of study drug. Only subjects with data available for each specified parameter were included in the analysis.
The BBPS score for each colon segment (left, transverse, right) was determined by the blinded colonoscopist as follows: * 0 = Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared * 1 = Portion of mucosa of the segment seen, but other areas of the colon segment not well seen due to staining, residual stool and/or opaque liquid * 2 = Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of segment seen well * 3 = Entire mucosa of segment seen well with no residual staining, small fragments of stool and/or opaque liquid. Each segment score ranged from 0-3. Global score was sum of the 3 segment scores and ranged from 0-9 (worst to best). Successful colon cleansing was defined as a global BBPS score ≥6. The adjusted mean score was estimated using a 2-way ANOVA, including treatment and country as covariates.
Outcome measures
| Measure |
Eziclen®/Izinova®
n=125 Participants
Subjects received Eziclen®/Izinova® oral sulphate salt solution, administered as ¾ of the adult dose, as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The 750 mL preparation was administered in 2 half doses as follows: the first half of preparation (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Approximately 2 hours after starting the first half of preparation, the second half (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Overall total volume (preparation + water) was 2250 mL (1125 mL per dose).
|
Klean-Prep®
n=116 Participants
Subjects received Klean-Prep® oral solution, administered as a 70 mL/kg dose (calculated based on subject's weight) as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The whole solution was administered in 2 half doses (1 litre per hour), with a 1-hour pause between the 2 half doses. Approximately 2 hours after starting the first half of preparation, the second half was drunk. The maximum global volume administered was 4000 mL (2000 mL per dose).
|
|---|---|---|
|
Mean Boston Bowel Preparation Scale (BBPS) Global Score and BBPS Scores by Colon Segment
Left colon
|
2.05 scores on a scale
Interval 1.89 to 2.22
|
2.12 scores on a scale
Interval 1.95 to 2.29
|
|
Mean Boston Bowel Preparation Scale (BBPS) Global Score and BBPS Scores by Colon Segment
Transverse colon
|
2.25 scores on a scale
Interval 2.1 to 2.4
|
2.33 scores on a scale
Interval 2.18 to 2.48
|
|
Mean Boston Bowel Preparation Scale (BBPS) Global Score and BBPS Scores by Colon Segment
Right colon
|
1.92 scores on a scale
Interval 1.74 to 2.09
|
2.16 scores on a scale
Interval 1.98 to 2.34
|
|
Mean Boston Bowel Preparation Scale (BBPS) Global Score and BBPS Scores by Colon Segment
Global score
|
6.25 scores on a scale
Interval 5.86 to 6.63
|
6.61 scores on a scale
Interval 6.21 to 7.01
|
SECONDARY outcome
Timeframe: At Day 2 (colonoscopy visit, before colonoscopy)Population: The ITT population included all randomised subjects who received even a partial dose of study drug. Only subjects with data available were included in the analysis (1 subject in the Eziclen®/Izinova® group had missing data so is not included in the overall number analysed).
The percentage of subjects who needed rescue treatment (saline enema) prior to colonoscopy because of inadequate preparation intake was assessed.
Outcome measures
| Measure |
Eziclen®/Izinova®
n=124 Participants
Subjects received Eziclen®/Izinova® oral sulphate salt solution, administered as ¾ of the adult dose, as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The 750 mL preparation was administered in 2 half doses as follows: the first half of preparation (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Approximately 2 hours after starting the first half of preparation, the second half (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Overall total volume (preparation + water) was 2250 mL (1125 mL per dose).
|
Klean-Prep®
n=116 Participants
Subjects received Klean-Prep® oral solution, administered as a 70 mL/kg dose (calculated based on subject's weight) as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The whole solution was administered in 2 half doses (1 litre per hour), with a 1-hour pause between the 2 half doses. Approximately 2 hours after starting the first half of preparation, the second half was drunk. The maximum global volume administered was 4000 mL (2000 mL per dose).
|
|---|---|---|
|
Percentage of Subjects With Need for Rescue Treatment
|
20.2 percentage of subjects
Interval 13.1 to 27.2
|
14.7 percentage of subjects
Interval 8.2 to 21.1
|
SECONDARY outcome
Timeframe: At Day 1 (treatment visit)Population: The ITT population included all randomised subjects who received even a partial dose of study drug.
The percentage of subjects who needed placement of a nasogastric tube to achieve administration of the complete preparation was assessed.
Outcome measures
| Measure |
Eziclen®/Izinova®
n=125 Participants
Subjects received Eziclen®/Izinova® oral sulphate salt solution, administered as ¾ of the adult dose, as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The 750 mL preparation was administered in 2 half doses as follows: the first half of preparation (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Approximately 2 hours after starting the first half of preparation, the second half (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Overall total volume (preparation + water) was 2250 mL (1125 mL per dose).
|
Klean-Prep®
n=116 Participants
Subjects received Klean-Prep® oral solution, administered as a 70 mL/kg dose (calculated based on subject's weight) as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The whole solution was administered in 2 half doses (1 litre per hour), with a 1-hour pause between the 2 half doses. Approximately 2 hours after starting the first half of preparation, the second half was drunk. The maximum global volume administered was 4000 mL (2000 mL per dose).
|
|---|---|---|
|
Percentage of Subjects With Need for Nasogastric Tube To Complete Preparation
|
7.2 percentage of subjects
Interval 2.7 to 11.7
|
31.0 percentage of subjects
Interval 22.6 to 39.5
|
SECONDARY outcome
Timeframe: At Day 2 (colonoscopy visit)Population: The ITT population included all randomised subjects who received even a partial dose of study drug.
The percentage of subjects with a complete colonoscopy, defined as a procedure that reached the caecum, was assessed.
Outcome measures
| Measure |
Eziclen®/Izinova®
n=125 Participants
Subjects received Eziclen®/Izinova® oral sulphate salt solution, administered as ¾ of the adult dose, as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The 750 mL preparation was administered in 2 half doses as follows: the first half of preparation (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Approximately 2 hours after starting the first half of preparation, the second half (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Overall total volume (preparation + water) was 2250 mL (1125 mL per dose).
|
Klean-Prep®
n=116 Participants
Subjects received Klean-Prep® oral solution, administered as a 70 mL/kg dose (calculated based on subject's weight) as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The whole solution was administered in 2 half doses (1 litre per hour), with a 1-hour pause between the 2 half doses. Approximately 2 hours after starting the first half of preparation, the second half was drunk. The maximum global volume administered was 4000 mL (2000 mL per dose).
|
|---|---|---|
|
Percentage of Subjects With Colonoscopy Procedure Documented as Completed
|
96.8 percentage of subjects
Interval 93.7 to 99.9
|
96.6 percentage of subjects
Interval 93.2 to 99.9
|
SECONDARY outcome
Timeframe: From colonoscope introduction to caecal intubation, assessed on Day 2 (colonoscopy visit)Population: The ITT population included all randomised subjects who received even a partial dose of study drug. Note: for 2 subjects in the Eziclen®/Izinova® group and 1 subject in the Klean-Prep® group, although the procedure reached the caecum, the time was not reported and consequently, these subjects could not be included in the analysis.
The time to caecal intubation was defined as the time from colonoscope introduction to caecal intubation, estimated using the Kaplan-Meier product limit method. In the event the procedure did not reach the caecum, the subject was censored at time of withdrawal of colonoscope.
Outcome measures
| Measure |
Eziclen®/Izinova®
n=123 Participants
Subjects received Eziclen®/Izinova® oral sulphate salt solution, administered as ¾ of the adult dose, as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The 750 mL preparation was administered in 2 half doses as follows: the first half of preparation (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Approximately 2 hours after starting the first half of preparation, the second half (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Overall total volume (preparation + water) was 2250 mL (1125 mL per dose).
|
Klean-Prep®
n=115 Participants
Subjects received Klean-Prep® oral solution, administered as a 70 mL/kg dose (calculated based on subject's weight) as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The whole solution was administered in 2 half doses (1 litre per hour), with a 1-hour pause between the 2 half doses. Approximately 2 hours after starting the first half of preparation, the second half was drunk. The maximum global volume administered was 4000 mL (2000 mL per dose).
|
|---|---|---|
|
Median Time to Caecal Intubation
|
13.0 minutes
Interval 10.0 to 15.0
|
15.0 minutes
Interval 12.0 to 15.0
|
SECONDARY outcome
Timeframe: From caecum intubation to withdrawal of the colonoscope, assessed on Day 2 (colonoscopy visit)Population: The ITT population included all randomised subjects who received even a partial dose of study drug. Only subjects with data available were included in the analysis (6 subjects in the Eziclen®/Izinova® group and 5 subjects in the Klean-Prep® group had missing data so are not included in the overall number analysed).
The duration of examination for colonoscopy (in minutes) was measured by the difference between the time of caecum intubation and the time of withdrawal of the colonoscope. The adjusted mean duration of examination was estimated using a 2-way ANOVA, including treatment and country as covariates. Subjects for whom the caecum was not reached were excluded from the analysis.
Outcome measures
| Measure |
Eziclen®/Izinova®
n=119 Participants
Subjects received Eziclen®/Izinova® oral sulphate salt solution, administered as ¾ of the adult dose, as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The 750 mL preparation was administered in 2 half doses as follows: the first half of preparation (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Approximately 2 hours after starting the first half of preparation, the second half (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Overall total volume (preparation + water) was 2250 mL (1125 mL per dose).
|
Klean-Prep®
n=111 Participants
Subjects received Klean-Prep® oral solution, administered as a 70 mL/kg dose (calculated based on subject's weight) as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The whole solution was administered in 2 half doses (1 litre per hour), with a 1-hour pause between the 2 half doses. Approximately 2 hours after starting the first half of preparation, the second half was drunk. The maximum global volume administered was 4000 mL (2000 mL per dose).
|
|---|---|---|
|
Mean Duration of Examination
|
14.77 minutes
Interval 12.63 to 16.92
|
15.70 minutes
Interval 13.5 to 17.9
|
SECONDARY outcome
Timeframe: At Day 1 (treatment visit)Population: The ITT population included all randomised subjects who received even a partial dose of study drug. Only subjects with data available were included in the analysis (6 subjects in the Klean-Prep® group had missing data so are not included in the overall number analysed).
The Treatment Acceptability Questionnaire was completed by the caregiver or subject after the subject ended the intake of preparation. Subject acceptability was rated as follows: * 1 = Very badly accepted/unacceptable * 2 = Badly but accepted * 3 = Neither good nor bad * 4 = Well accepted * 5 = Very well accepted. Overall acceptability score is the average of scores from the 2 doses ranging from 1 - 5 (worst to best). The adjusted mean score was estimated using a 2-way ANOVA, including treatment and country as covariates.
Outcome measures
| Measure |
Eziclen®/Izinova®
n=125 Participants
Subjects received Eziclen®/Izinova® oral sulphate salt solution, administered as ¾ of the adult dose, as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The 750 mL preparation was administered in 2 half doses as follows: the first half of preparation (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Approximately 2 hours after starting the first half of preparation, the second half (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Overall total volume (preparation + water) was 2250 mL (1125 mL per dose).
|
Klean-Prep®
n=110 Participants
Subjects received Klean-Prep® oral solution, administered as a 70 mL/kg dose (calculated based on subject's weight) as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The whole solution was administered in 2 half doses (1 litre per hour), with a 1-hour pause between the 2 half doses. Approximately 2 hours after starting the first half of preparation, the second half was drunk. The maximum global volume administered was 4000 mL (2000 mL per dose).
|
|---|---|---|
|
Mean Score for Overall Treatment Acceptability, Assessed Using Treatment Acceptability Questionnaire
|
2.93 scores on a scale
Interval 2.65 to 3.21
|
2.22 scores on a scale
Interval 1.92 to 2.51
|
SECONDARY outcome
Timeframe: At Day 1 (treatment visit)Population: The ITT population included all randomised subjects who received even a partial dose of study drug.
Treatment compliance according the instructions of use provided in the prescription was assessed as the percentage of volume of fluid taken relative to the planned volume of fluid to be taken (measured by the caregiver and reported in the treatment questionnaire of subject's leaflet during treatment administration). Overall treatment compliance was derived from the total volumes of fluid (i.e. preparation + hydration for Eziclen®/Izinova® and preparation only for Klean-Prep®) and was assessed for dose 1, dose 2 and globally (accounting for both doses). The adjusted mean overall treatment compliance (%) was estimated using a 2-way ANOVA, including treatment and country as covariates.
Outcome measures
| Measure |
Eziclen®/Izinova®
n=125 Participants
Subjects received Eziclen®/Izinova® oral sulphate salt solution, administered as ¾ of the adult dose, as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The 750 mL preparation was administered in 2 half doses as follows: the first half of preparation (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Approximately 2 hours after starting the first half of preparation, the second half (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Overall total volume (preparation + water) was 2250 mL (1125 mL per dose).
|
Klean-Prep®
n=116 Participants
Subjects received Klean-Prep® oral solution, administered as a 70 mL/kg dose (calculated based on subject's weight) as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The whole solution was administered in 2 half doses (1 litre per hour), with a 1-hour pause between the 2 half doses. Approximately 2 hours after starting the first half of preparation, the second half was drunk. The maximum global volume administered was 4000 mL (2000 mL per dose).
|
|---|---|---|
|
Mean Overall Treatment Compliance
Dose 1
|
96.74 adjusted percentage of fluid volume (mL)
Interval 94.19 to 99.3
|
95.52 adjusted percentage of fluid volume (mL)
Interval 92.9 to 98.13
|
|
Mean Overall Treatment Compliance
Dose 2
|
93.53 adjusted percentage of fluid volume (mL)
Interval 89.24 to 97.81
|
87.14 adjusted percentage of fluid volume (mL)
Interval 82.76 to 91.53
|
|
Mean Overall Treatment Compliance
Global
|
96.82 adjusted percentage of fluid volume (mL)
Interval 93.32 to 100.31
|
89.34 adjusted percentage of fluid volume (mL)
Interval 85.74 to 92.93
|
SECONDARY outcome
Timeframe: At Day 1 (treatment visit)Population: The safety population included all randomised subjects who received even a partial dose of study drug. Subjects were assessed according to the treatment received (1 subject randomised to the Eziclen®/Izinova® group was mistakenly administered Klean-Prep®; this subject was therefore included in the Klean-Prep® safety population).
Tolerability was assessed using a Symptom Scale after each dose of treatment for stomach cramping, stomach bloating and nausea on a paediatric 5-point scale as follows: * 1 = No symptom * 2 = Mild * 3 = Bothersome * 4 = Distressing * 5 = Severely distressing symptoms. The total tolerability score is the sum of the scores for the 3 symptoms ranging from 3 to 15 (best to worst). Mean total tolerability scores after dose 1 and dose 2 are presented.
Outcome measures
| Measure |
Eziclen®/Izinova®
n=124 Participants
Subjects received Eziclen®/Izinova® oral sulphate salt solution, administered as ¾ of the adult dose, as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The 750 mL preparation was administered in 2 half doses as follows: the first half of preparation (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Approximately 2 hours after starting the first half of preparation, the second half (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Overall total volume (preparation + water) was 2250 mL (1125 mL per dose).
|
Klean-Prep®
n=117 Participants
Subjects received Klean-Prep® oral solution, administered as a 70 mL/kg dose (calculated based on subject's weight) as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The whole solution was administered in 2 half doses (1 litre per hour), with a 1-hour pause between the 2 half doses. Approximately 2 hours after starting the first half of preparation, the second half was drunk. The maximum global volume administered was 4000 mL (2000 mL per dose).
|
|---|---|---|
|
Mean Subject Tolerability Total Score, Assessed Using a Symptom Scale
Dose 1
|
5.48 scores on a scale
Standard Deviation 2.42
|
6.34 scores on a scale
Standard Deviation 2.78
|
|
Mean Subject Tolerability Total Score, Assessed Using a Symptom Scale
Dose 2
|
5.93 scores on a scale
Standard Deviation 2.58
|
6.71 scores on a scale
Standard Deviation 3.07
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From first intake of prescription to first clear watery stool, assessed on Day 1 (treatment visit) and Day 2 (colonoscopy visit)Population: The ITT population included all randomised subjects who received even a partial dose of study drug.
The time to clear effluent, as reported by the subject, was defined as the time between first intake of prescription and first clear watery stool, estimated using the Kaplan-Meier product limit method. In the event of no clear watery stools, subjects with colonoscopy were censored at the time of colonoscope introduction, and subjects without colonoscopy were censored at time of start of treatment + 12 hours. Although time to clear effluent was pre-specified as a secondary endpoint in the study protocol, in a change to the planned analysis, it was subsequently analysed and reported as an 'other' efficacy endpoint.
Outcome measures
| Measure |
Eziclen®/Izinova®
n=125 Participants
Subjects received Eziclen®/Izinova® oral sulphate salt solution, administered as ¾ of the adult dose, as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The 750 mL preparation was administered in 2 half doses as follows: the first half of preparation (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Approximately 2 hours after starting the first half of preparation, the second half (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Overall total volume (preparation + water) was 2250 mL (1125 mL per dose).
|
Klean-Prep®
n=116 Participants
Subjects received Klean-Prep® oral solution, administered as a 70 mL/kg dose (calculated based on subject's weight) as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The whole solution was administered in 2 half doses (1 litre per hour), with a 1-hour pause between the 2 half doses. Approximately 2 hours after starting the first half of preparation, the second half was drunk. The maximum global volume administered was 4000 mL (2000 mL per dose).
|
|---|---|---|
|
Median Time to Clear Effluent
|
4.3 hours
Interval 3.5 to 5.3
|
4.8 hours
Interval 3.8 to 5.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From end of treatment administration to start of colonoscopy, assessed on Day 1 (treatment visit) and Day 2 (colonoscopy visit)Population: The ITT population included all randomised subjects who received even a partial dose of study drug.
The time between the end of treatment administration (on Day 1) and the start of colonoscopy (on Day 2) was determined. The adjusted mean time between the last intake of fluids and the start of colonoscopy procedure was estimated using a 2-way ANOVA, including treatment and country as covariates.
Outcome measures
| Measure |
Eziclen®/Izinova®
n=125 Participants
Subjects received Eziclen®/Izinova® oral sulphate salt solution, administered as ¾ of the adult dose, as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The 750 mL preparation was administered in 2 half doses as follows: the first half of preparation (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Approximately 2 hours after starting the first half of preparation, the second half (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Overall total volume (preparation + water) was 2250 mL (1125 mL per dose).
|
Klean-Prep®
n=116 Participants
Subjects received Klean-Prep® oral solution, administered as a 70 mL/kg dose (calculated based on subject's weight) as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The whole solution was administered in 2 half doses (1 litre per hour), with a 1-hour pause between the 2 half doses. Approximately 2 hours after starting the first half of preparation, the second half was drunk. The maximum global volume administered was 4000 mL (2000 mL per dose).
|
|---|---|---|
|
Mean Time Between Last Intake of Fluids and Start of Colonoscopy Procedure
|
15.30 hours
Interval 14.72 to 15.88
|
14.25 hours
Interval 13.65 to 14.84
|
Adverse Events
Eziclen®/Izinova®
Serious events: 4 serious events
Other events: 111 other events
Deaths: 0 deaths
Klean-Prep®
Serious events: 3 serious events
Other events: 105 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Eziclen®/Izinova®
n=124 participants at risk
Subjects received Eziclen®/Izinova® oral sulphate salt solution, administered as ¾ of the adult dose, as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The 750 mL preparation was administered in 2 half doses as follows: the first half of preparation (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Approximately 2 hours after starting the first half of preparation, the second half (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Overall total volume (preparation + water) was 2250 mL (1125 mL per dose).
|
Klean-Prep®
n=117 participants at risk
Subjects received Klean-Prep® oral solution, administered as a 70 mL/kg dose (calculated based on subject's weight) as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The whole solution was administered in 2 half doses (1 litre per hour), with a 1-hour pause between the 2 half doses. Approximately 2 hours after starting the first half of preparation, the second half was drunk. The maximum global volume administered was 4000 mL (2000 mL per dose).
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.81%
1/124 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 up to Day 32 (30 days [-5+/15] after colonoscopy).
The safety population included all randomised subjects who received even a partial dose of study drug. Subjects were assessed according to the treatment received (1 subject randomised to the Eziclen®/Izinova® group was mistakenly administered Klean-Prep®; this subject was therefore included in the Klean-Prep® safety population).
|
0.00%
0/117 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 up to Day 32 (30 days [-5+/15] after colonoscopy).
The safety population included all randomised subjects who received even a partial dose of study drug. Subjects were assessed according to the treatment received (1 subject randomised to the Eziclen®/Izinova® group was mistakenly administered Klean-Prep®; this subject was therefore included in the Klean-Prep® safety population).
|
|
Gastrointestinal disorders
Crohn's disease
|
1.6%
2/124 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 up to Day 32 (30 days [-5+/15] after colonoscopy).
The safety population included all randomised subjects who received even a partial dose of study drug. Subjects were assessed according to the treatment received (1 subject randomised to the Eziclen®/Izinova® group was mistakenly administered Klean-Prep®; this subject was therefore included in the Klean-Prep® safety population).
|
0.85%
1/117 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 up to Day 32 (30 days [-5+/15] after colonoscopy).
The safety population included all randomised subjects who received even a partial dose of study drug. Subjects were assessed according to the treatment received (1 subject randomised to the Eziclen®/Izinova® group was mistakenly administered Klean-Prep®; this subject was therefore included in the Klean-Prep® safety population).
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.81%
1/124 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 up to Day 32 (30 days [-5+/15] after colonoscopy).
The safety population included all randomised subjects who received even a partial dose of study drug. Subjects were assessed according to the treatment received (1 subject randomised to the Eziclen®/Izinova® group was mistakenly administered Klean-Prep®; this subject was therefore included in the Klean-Prep® safety population).
|
0.00%
0/117 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 up to Day 32 (30 days [-5+/15] after colonoscopy).
The safety population included all randomised subjects who received even a partial dose of study drug. Subjects were assessed according to the treatment received (1 subject randomised to the Eziclen®/Izinova® group was mistakenly administered Klean-Prep®; this subject was therefore included in the Klean-Prep® safety population).
|
|
Gastrointestinal disorders
Intestinal stenosis
|
0.81%
1/124 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 up to Day 32 (30 days [-5+/15] after colonoscopy).
The safety population included all randomised subjects who received even a partial dose of study drug. Subjects were assessed according to the treatment received (1 subject randomised to the Eziclen®/Izinova® group was mistakenly administered Klean-Prep®; this subject was therefore included in the Klean-Prep® safety population).
|
0.00%
0/117 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 up to Day 32 (30 days [-5+/15] after colonoscopy).
The safety population included all randomised subjects who received even a partial dose of study drug. Subjects were assessed according to the treatment received (1 subject randomised to the Eziclen®/Izinova® group was mistakenly administered Klean-Prep®; this subject was therefore included in the Klean-Prep® safety population).
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/124 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 up to Day 32 (30 days [-5+/15] after colonoscopy).
The safety population included all randomised subjects who received even a partial dose of study drug. Subjects were assessed according to the treatment received (1 subject randomised to the Eziclen®/Izinova® group was mistakenly administered Klean-Prep®; this subject was therefore included in the Klean-Prep® safety population).
|
0.85%
1/117 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 up to Day 32 (30 days [-5+/15] after colonoscopy).
The safety population included all randomised subjects who received even a partial dose of study drug. Subjects were assessed according to the treatment received (1 subject randomised to the Eziclen®/Izinova® group was mistakenly administered Klean-Prep®; this subject was therefore included in the Klean-Prep® safety population).
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/124 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 up to Day 32 (30 days [-5+/15] after colonoscopy).
The safety population included all randomised subjects who received even a partial dose of study drug. Subjects were assessed according to the treatment received (1 subject randomised to the Eziclen®/Izinova® group was mistakenly administered Klean-Prep®; this subject was therefore included in the Klean-Prep® safety population).
|
0.85%
1/117 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 up to Day 32 (30 days [-5+/15] after colonoscopy).
The safety population included all randomised subjects who received even a partial dose of study drug. Subjects were assessed according to the treatment received (1 subject randomised to the Eziclen®/Izinova® group was mistakenly administered Klean-Prep®; this subject was therefore included in the Klean-Prep® safety population).
|
Other adverse events
| Measure |
Eziclen®/Izinova®
n=124 participants at risk
Subjects received Eziclen®/Izinova® oral sulphate salt solution, administered as ¾ of the adult dose, as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The 750 mL preparation was administered in 2 half doses as follows: the first half of preparation (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Approximately 2 hours after starting the first half of preparation, the second half (375 mL) was drunk slowly in 30 minutes to 1 hour, followed by 750 mL of water over the next hour. Overall total volume (preparation + water) was 2250 mL (1125 mL per dose).
|
Klean-Prep®
n=117 participants at risk
Subjects received Klean-Prep® oral solution, administered as a 70 mL/kg dose (calculated based on subject's weight) as a 1-day regimen on the evening of the day before colonoscopy (Day 1). The whole solution was administered in 2 half doses (1 litre per hour), with a 1-hour pause between the 2 half doses. Approximately 2 hours after starting the first half of preparation, the second half was drunk. The maximum global volume administered was 4000 mL (2000 mL per dose).
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
72.6%
90/124 • Number of events 123 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 up to Day 32 (30 days [-5+/15] after colonoscopy).
The safety population included all randomised subjects who received even a partial dose of study drug. Subjects were assessed according to the treatment received (1 subject randomised to the Eziclen®/Izinova® group was mistakenly administered Klean-Prep®; this subject was therefore included in the Klean-Prep® safety population).
|
71.8%
84/117 • Number of events 115 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 up to Day 32 (30 days [-5+/15] after colonoscopy).
The safety population included all randomised subjects who received even a partial dose of study drug. Subjects were assessed according to the treatment received (1 subject randomised to the Eziclen®/Izinova® group was mistakenly administered Klean-Prep®; this subject was therefore included in the Klean-Prep® safety population).
|
|
Gastrointestinal disorders
Abdominal distension
|
54.0%
67/124 • Number of events 91 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 up to Day 32 (30 days [-5+/15] after colonoscopy).
The safety population included all randomised subjects who received even a partial dose of study drug. Subjects were assessed according to the treatment received (1 subject randomised to the Eziclen®/Izinova® group was mistakenly administered Klean-Prep®; this subject was therefore included in the Klean-Prep® safety population).
|
65.8%
77/117 • Number of events 107 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 up to Day 32 (30 days [-5+/15] after colonoscopy).
The safety population included all randomised subjects who received even a partial dose of study drug. Subjects were assessed according to the treatment received (1 subject randomised to the Eziclen®/Izinova® group was mistakenly administered Klean-Prep®; this subject was therefore included in the Klean-Prep® safety population).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
51.6%
64/124 • Number of events 83 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 up to Day 32 (30 days [-5+/15] after colonoscopy).
The safety population included all randomised subjects who received even a partial dose of study drug. Subjects were assessed according to the treatment received (1 subject randomised to the Eziclen®/Izinova® group was mistakenly administered Klean-Prep®; this subject was therefore included in the Klean-Prep® safety population).
|
54.7%
64/117 • Number of events 84 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 up to Day 32 (30 days [-5+/15] after colonoscopy).
The safety population included all randomised subjects who received even a partial dose of study drug. Subjects were assessed according to the treatment received (1 subject randomised to the Eziclen®/Izinova® group was mistakenly administered Klean-Prep®; this subject was therefore included in the Klean-Prep® safety population).
|
|
Gastrointestinal disorders
Vomiting
|
8.9%
11/124 • Number of events 11 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 up to Day 32 (30 days [-5+/15] after colonoscopy).
The safety population included all randomised subjects who received even a partial dose of study drug. Subjects were assessed according to the treatment received (1 subject randomised to the Eziclen®/Izinova® group was mistakenly administered Klean-Prep®; this subject was therefore included in the Klean-Prep® safety population).
|
8.5%
10/117 • Number of events 11 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 up to Day 32 (30 days [-5+/15] after colonoscopy).
The safety population included all randomised subjects who received even a partial dose of study drug. Subjects were assessed according to the treatment received (1 subject randomised to the Eziclen®/Izinova® group was mistakenly administered Klean-Prep®; this subject was therefore included in the Klean-Prep® safety population).
|
|
Gastrointestinal disorders
Crohn's disease
|
7.3%
9/124 • Number of events 9 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 up to Day 32 (30 days [-5+/15] after colonoscopy).
The safety population included all randomised subjects who received even a partial dose of study drug. Subjects were assessed according to the treatment received (1 subject randomised to the Eziclen®/Izinova® group was mistakenly administered Klean-Prep®; this subject was therefore included in the Klean-Prep® safety population).
|
1.7%
2/117 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 up to Day 32 (30 days [-5+/15] after colonoscopy).
The safety population included all randomised subjects who received even a partial dose of study drug. Subjects were assessed according to the treatment received (1 subject randomised to the Eziclen®/Izinova® group was mistakenly administered Klean-Prep®; this subject was therefore included in the Klean-Prep® safety population).
|
|
Gastrointestinal disorders
Abdominal pain
|
4.8%
6/124 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 up to Day 32 (30 days [-5+/15] after colonoscopy).
The safety population included all randomised subjects who received even a partial dose of study drug. Subjects were assessed according to the treatment received (1 subject randomised to the Eziclen®/Izinova® group was mistakenly administered Klean-Prep®; this subject was therefore included in the Klean-Prep® safety population).
|
2.6%
3/117 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 up to Day 32 (30 days [-5+/15] after colonoscopy).
The safety population included all randomised subjects who received even a partial dose of study drug. Subjects were assessed according to the treatment received (1 subject randomised to the Eziclen®/Izinova® group was mistakenly administered Klean-Prep®; this subject was therefore included in the Klean-Prep® safety population).
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.81%
1/124 • Number of events 1 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 up to Day 32 (30 days [-5+/15] after colonoscopy).
The safety population included all randomised subjects who received even a partial dose of study drug. Subjects were assessed according to the treatment received (1 subject randomised to the Eziclen®/Izinova® group was mistakenly administered Klean-Prep®; this subject was therefore included in the Klean-Prep® safety population).
|
5.1%
6/117 • Number of events 6 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 up to Day 32 (30 days [-5+/15] after colonoscopy).
The safety population included all randomised subjects who received even a partial dose of study drug. Subjects were assessed according to the treatment received (1 subject randomised to the Eziclen®/Izinova® group was mistakenly administered Klean-Prep®; this subject was therefore included in the Klean-Prep® safety population).
|
|
Gastrointestinal disorders
Gastritis
|
3.2%
4/124 • Number of events 4 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 up to Day 32 (30 days [-5+/15] after colonoscopy).
The safety population included all randomised subjects who received even a partial dose of study drug. Subjects were assessed according to the treatment received (1 subject randomised to the Eziclen®/Izinova® group was mistakenly administered Klean-Prep®; this subject was therefore included in the Klean-Prep® safety population).
|
2.6%
3/117 • Number of events 3 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 up to Day 32 (30 days [-5+/15] after colonoscopy).
The safety population included all randomised subjects who received even a partial dose of study drug. Subjects were assessed according to the treatment received (1 subject randomised to the Eziclen®/Izinova® group was mistakenly administered Klean-Prep®; this subject was therefore included in the Klean-Prep® safety population).
|
|
Nervous system disorders
Headache
|
7.3%
9/124 • Number of events 9 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 up to Day 32 (30 days [-5+/15] after colonoscopy).
The safety population included all randomised subjects who received even a partial dose of study drug. Subjects were assessed according to the treatment received (1 subject randomised to the Eziclen®/Izinova® group was mistakenly administered Klean-Prep®; this subject was therefore included in the Klean-Prep® safety population).
|
1.7%
2/117 • Number of events 2 • Treatment-emergent adverse events (TEAEs) were collected from Day 1 up to Day 32 (30 days [-5+/15] after colonoscopy).
The safety population included all randomised subjects who received even a partial dose of study drug. Subjects were assessed according to the treatment received (1 subject randomised to the Eziclen®/Izinova® group was mistakenly administered Klean-Prep®; this subject was therefore included in the Klean-Prep® safety population).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor requires that reasonable opportunity be given to review the content and conclusions of any abstract, presentation, or paper before the material is submitted for publication or communicated. The sponsor will comment on the draft documents within the time period agreed in the contractual arrangements. Requested amendments will be incorporated by the author, provided they do not alter the scientific value of the material.
- Publication restrictions are in place
Restriction type: OTHER