Trial Outcomes & Findings for Efficacy, Safety and Tolerability of Eziclen in Adult Subjects Undergoing Colonoscopy (NCT NCT02321462)
NCT ID: NCT02321462
Last Updated: 2019-03-04
Results Overview
The BBPS score for each colon segment (right, transverse and left colon) was assessed by 3 blinded experts as follows: 0=unprepared segment with mucosa not seen due to solid stool that cannot be cleared , 1=portion of mucosa of the segment seen, but other areas 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. A reconciled score based on the 3 blinded reviews was used to calculate the global BBPS score, ranging from 0 to 9 (worst to best). A successful overall colon preparation was defined as a global score ≥6 for the 3 colon segments. The percentage of patients with a successful preparation was determined using a logistic regression model, adjusted on centre, age class (\<= 65; \> 65), gender and inflammatory bowel disease (IBD) status.
COMPLETED
PHASE3
296 participants
Colonoscopy was performed on Day 2.
2019-03-04
Participant Flow
Adult patients due to undergo colonoscopy for a routine diagnostic indication were enrolled into this noninferiority phase 3 study at 3 study centres in Russia. First patient started: 13 March 2015; last patient completed: 28 December 2015.
305 patients were screened for inclusion, and 296 patients met all inclusion criteria and none of the exclusion criteria and were randomised to treatment. 294 patients received study treatment, and 2 patients were excluded from the safety and intention-to-treat (ITT) populations as they did not receive study treatment prior to colonoscopy.
Participant milestones
| Measure |
Eziclen
Patients were randomised to receive an oral split-dose of Eziclen on Day 1 and Day 2. The first dose was taken the evening of Day 1 before the colonoscopy and the second dose was taken 10 - 12 hours after the evening dose on the day of the colonoscopy. Colonoscopy was performed on Day 2, at least 1 hour and no more than 6 hours after the last dose of Eziclen.
|
Fortrans®
Patients were randomised to receive an oral split-dose of Fortrans® on Day 1 and Day 2. The first dose was taken the evening of Day 1 before the colonoscopy and the second dose was taken 10 - 12 hours after the evening dose on the day of the colonoscopy. Colonoscopy was performed on Day 2, at least 3 hours and no more than 6 hours after the last dose of Fortrans®.
|
|---|---|---|
|
Overall Study
STARTED
|
147
|
149
|
|
Overall Study
ITT Population
|
146
|
148
|
|
Overall Study
Treated Patients
|
147
|
147
|
|
Overall Study
Safety Population
|
147
|
147
|
|
Overall Study
COMPLETED
|
141
|
146
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
| Measure |
Eziclen
Patients were randomised to receive an oral split-dose of Eziclen on Day 1 and Day 2. The first dose was taken the evening of Day 1 before the colonoscopy and the second dose was taken 10 - 12 hours after the evening dose on the day of the colonoscopy. Colonoscopy was performed on Day 2, at least 1 hour and no more than 6 hours after the last dose of Eziclen.
|
Fortrans®
Patients were randomised to receive an oral split-dose of Fortrans® on Day 1 and Day 2. The first dose was taken the evening of Day 1 before the colonoscopy and the second dose was taken 10 - 12 hours after the evening dose on the day of the colonoscopy. Colonoscopy was performed on Day 2, at least 3 hours and no more than 6 hours after the last dose of Fortrans®.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
2
|
|
Overall Study
Subject withdrawn before any treatment
|
1
|
1
|
Baseline Characteristics
Efficacy, Safety and Tolerability of Eziclen in Adult Subjects Undergoing Colonoscopy
Baseline characteristics by cohort
| Measure |
Eziclen
n=147 Participants
Patients were randomised to receive an oral split-dose of Eziclen on Day 1 and Day 2. The first dose was taken the evening of Day 1 before the colonoscopy and the second dose was taken 10 - 12 hours after the evening dose on the day of the colonoscopy. Colonoscopy was performed on Day 2, at least 1 hour and no more than 6 hours after the last dose of Eziclen.
|
Fortrans®
n=147 Participants
Patients were randomised to receive an oral split-dose of Fortrans® on Day 1 and Day 2. The first dose was taken the evening of Day 1 before the colonoscopy and the second dose was taken 10 - 12 hours after the evening dose on the day of the colonoscopy. Colonoscopy was performed on Day 2, at least 3 hours and no more than 6 hours after the last dose of Fortrans®.
|
Total Title
n=294 Participants
|
|---|---|---|---|
|
Age, Continuous
|
53.6 years
STANDARD_DEVIATION 13.0 • n=99 Participants
|
54.0 years
STANDARD_DEVIATION 13.0 • n=107 Participants
|
53.8 years
STANDARD_DEVIATION 12.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
108 Participants
n=99 Participants
|
105 Participants
n=107 Participants
|
213 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
81 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Colonoscopy was performed on Day 2.Population: The per protocol (PP) population consisted of all randomised patients who received the preparation of study treatment (complete or partial), who underwent the colonoscopy procedure and for whom no major protocol violation occurred until colonoscopy. Patients were assessed according to the randomised treatment, regardless of treatment received.
The BBPS score for each colon segment (right, transverse and left colon) was assessed by 3 blinded experts as follows: 0=unprepared segment with mucosa not seen due to solid stool that cannot be cleared , 1=portion of mucosa of the segment seen, but other areas 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. A reconciled score based on the 3 blinded reviews was used to calculate the global BBPS score, ranging from 0 to 9 (worst to best). A successful overall colon preparation was defined as a global score ≥6 for the 3 colon segments. The percentage of patients with a successful preparation was determined using a logistic regression model, adjusted on centre, age class (\<= 65; \> 65), gender and inflammatory bowel disease (IBD) status.
Outcome measures
| Measure |
Eziclen
n=139 Participants
Patients were randomised to receive an oral split-dose of Eziclen on Day 1 and Day 2. The first dose was taken the evening of Day 1 before the colonoscopy and the second dose was taken 10 - 12 hours after the evening dose on the day of the colonoscopy. Colonoscopy was performed on Day 2, at least 1 hour and no more than 6 hours after the last dose of Eziclen.
|
Fortrans®
n=135 Participants
Patients were randomised to receive an oral split-dose of Fortrans® on Day 1 and Day 2. The first dose was taken the evening of Day 1 before the colonoscopy and the second dose was taken 10 - 12 hours after the evening dose on the day of the colonoscopy. Colonoscopy was performed on Day 2, at least 3 hours and no more than 6 hours after the last dose of Fortrans®.
|
|---|---|---|
|
Adjusted Percentage of Patients With Successful Overall Colon Preparation, Assessed by the Global Score of the Boston Bowel Preparation Scale (BBPS).
|
97.18 Adjusted percentage of patients
Interval 89.48 to 99.29
|
97.65 Adjusted percentage of patients
Interval 90.67 to 99.44
|
SECONDARY outcome
Timeframe: Colonoscopy was performed on Day 2.Population: The ITT population consisted of all randomised patients who received even a partial dose of study treatment. Patients were assessed according to the randomised treatment, regardless of treatment received. Only patients with data available are included.
The mean global BBPS scores and scores by colon segment are presented for the ITT population. For each of the 3 colon segments (right, transverse and left colon) the BBPS score ranges from 0 - 3 (worst to best), and was assessed by 3 blinded experts: * unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared = 0 * portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool and/or opaque liquid = 1 * minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well = 2 * entire mucosa of colon segment seen well with no residual staining, small fragments of stool and/or opaque liquid = 3. The global score is the total of the 3 segment scores ranging from 0 - 9 (worst to best). Reconciled scores were based on 3 blinded reviews. Results of analysis for the PP population for right + transverse colon segments presented separately.
Outcome measures
| Measure |
Eziclen
n=140 Participants
Patients were randomised to receive an oral split-dose of Eziclen on Day 1 and Day 2. The first dose was taken the evening of Day 1 before the colonoscopy and the second dose was taken 10 - 12 hours after the evening dose on the day of the colonoscopy. Colonoscopy was performed on Day 2, at least 1 hour and no more than 6 hours after the last dose of Eziclen.
|
Fortrans®
n=142 Participants
Patients were randomised to receive an oral split-dose of Fortrans® on Day 1 and Day 2. The first dose was taken the evening of Day 1 before the colonoscopy and the second dose was taken 10 - 12 hours after the evening dose on the day of the colonoscopy. Colonoscopy was performed on Day 2, at least 3 hours and no more than 6 hours after the last dose of Fortrans®.
|
|---|---|---|
|
Mean BBPS Score by Segment and Globally (ITT Population)
Right Colon BBPS Score
|
2.56 units on a scale
Standard Deviation 0.58
|
2.42 units on a scale
Standard Deviation 0.62
|
|
Mean BBPS Score by Segment and Globally (ITT Population)
Transverse Colon BBPS Score
|
2.78 units on a scale
Standard Deviation 0.43
|
2.67 units on a scale
Standard Deviation 0.52
|
|
Mean BBPS Score by Segment and Globally (ITT Population)
Left Colon BBPS Score
|
2.84 units on a scale
Standard Deviation 0.39
|
2.78 units on a scale
Standard Deviation 0.48
|
|
Mean BBPS Score by Segment and Globally (ITT Population)
Global BBPS Score
|
8.17 units on a scale
Standard Deviation 1.21
|
7.86 units on a scale
Standard Deviation 1.39
|
SECONDARY outcome
Timeframe: Colonoscopy was performed on Day 2.Population: The PP population consisted of all randomised patients who received the preparation of study treatment (whether complete or partial), who underwent the colonoscopy procedure and for whom no protocol violation occurred until colonoscopy. Patients were assessed according to the randomised treatment, regardless of treatment received.
The mean colon segment BBPS scores for the Right Colon and Transverse Colon segments for the PP population are presented. For each of the colon segments (right and transverse colon) the BBPS score ranges from 0 - 3 (worst to best), and was assessed by 3 blinded experts as follows: * unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared = 0 * portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool and/or opaque liquid = 1 * minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well = 2 * entire mucosa of colon segment seen well with no residual staining, small fragments of stool and/or opaque liquid = 3. Reconciled scores were based on the 3 blinded reviews.
Outcome measures
| Measure |
Eziclen
n=139 Participants
Patients were randomised to receive an oral split-dose of Eziclen on Day 1 and Day 2. The first dose was taken the evening of Day 1 before the colonoscopy and the second dose was taken 10 - 12 hours after the evening dose on the day of the colonoscopy. Colonoscopy was performed on Day 2, at least 1 hour and no more than 6 hours after the last dose of Eziclen.
|
Fortrans®
n=135 Participants
Patients were randomised to receive an oral split-dose of Fortrans® on Day 1 and Day 2. The first dose was taken the evening of Day 1 before the colonoscopy and the second dose was taken 10 - 12 hours after the evening dose on the day of the colonoscopy. Colonoscopy was performed on Day 2, at least 3 hours and no more than 6 hours after the last dose of Fortrans®.
|
|---|---|---|
|
Mean BBPS Score for Right Colon and Transverse Colon Segment (PP Population)
Right Colon BBPS Score
|
2.55 units on a scale
Standard Deviation 0.58
|
2.46 units on a scale
Standard Deviation 0.56
|
|
Mean BBPS Score for Right Colon and Transverse Colon Segment (PP Population)
Transverse Colon BBPS Score
|
2.78 units on a scale
Standard Deviation 0.43
|
2.70 units on a scale
Standard Deviation 0.46
|
SECONDARY outcome
Timeframe: Colonoscopy was performed on Day 2.Population: The ITT population consisted of all randomised patients who received even a partial dose of study treatment. Patients were assessed according to the randomised treatment, regardless of treatment received. Percentages are calculated based on the overall ITT population.
The percentage of patients for whom polyps, adenomas and other lesions were detected during the colonoscopy are presented.
Outcome measures
| Measure |
Eziclen
n=146 Participants
Patients were randomised to receive an oral split-dose of Eziclen on Day 1 and Day 2. The first dose was taken the evening of Day 1 before the colonoscopy and the second dose was taken 10 - 12 hours after the evening dose on the day of the colonoscopy. Colonoscopy was performed on Day 2, at least 1 hour and no more than 6 hours after the last dose of Eziclen.
|
Fortrans®
n=148 Participants
Patients were randomised to receive an oral split-dose of Fortrans® on Day 1 and Day 2. The first dose was taken the evening of Day 1 before the colonoscopy and the second dose was taken 10 - 12 hours after the evening dose on the day of the colonoscopy. Colonoscopy was performed on Day 2, at least 3 hours and no more than 6 hours after the last dose of Fortrans®.
|
|---|---|---|
|
The Percentage of Patients in Whom Lesions Were Detected.
Other lesions detected
|
15.1 percentage of participants
|
16.9 percentage of participants
|
|
The Percentage of Patients in Whom Lesions Were Detected.
Polyps detected
|
27.4 percentage of participants
|
33.8 percentage of participants
|
|
The Percentage of Patients in Whom Lesions Were Detected.
Adenomas detected
|
20.5 percentage of participants
|
18.9 percentage of participants
|
SECONDARY outcome
Timeframe: Colonoscopy was performed on Day 2.Population: The ITT population consisted of all randomised patients who received even a partial dose of study treatment. Patients were assessed according to the randomised treatment, regardless of treatment received.
The percentage of patients for whom a total colonoscopy could be completed is presented.
Outcome measures
| Measure |
Eziclen
n=146 Participants
Patients were randomised to receive an oral split-dose of Eziclen on Day 1 and Day 2. The first dose was taken the evening of Day 1 before the colonoscopy and the second dose was taken 10 - 12 hours after the evening dose on the day of the colonoscopy. Colonoscopy was performed on Day 2, at least 1 hour and no more than 6 hours after the last dose of Eziclen.
|
Fortrans®
n=148 Participants
Patients were randomised to receive an oral split-dose of Fortrans® on Day 1 and Day 2. The first dose was taken the evening of Day 1 before the colonoscopy and the second dose was taken 10 - 12 hours after the evening dose on the day of the colonoscopy. Colonoscopy was performed on Day 2, at least 3 hours and no more than 6 hours after the last dose of Fortrans®.
|
|---|---|---|
|
The Percentage of Patients for Whom the Colonoscopy Was Completed
|
96.6 percentage of participants
|
97.3 percentage of participants
|
SECONDARY outcome
Timeframe: Colonoscopy was performed on Day 2.Population: The ITT population consisted of all randomised patients who received even a partial dose of study treatment. Patients were assessed according to the randomised treatment, regardless of treatment received. Only patients with data available are included.
The mean colonoscopy duration per treatment group is presented. The duration of colonoscopy was defined as the time from colonoscopy insertion to the time to reach the caecum in minutes.
Outcome measures
| Measure |
Eziclen
n=141 Participants
Patients were randomised to receive an oral split-dose of Eziclen on Day 1 and Day 2. The first dose was taken the evening of Day 1 before the colonoscopy and the second dose was taken 10 - 12 hours after the evening dose on the day of the colonoscopy. Colonoscopy was performed on Day 2, at least 1 hour and no more than 6 hours after the last dose of Eziclen.
|
Fortrans®
n=144 Participants
Patients were randomised to receive an oral split-dose of Fortrans® on Day 1 and Day 2. The first dose was taken the evening of Day 1 before the colonoscopy and the second dose was taken 10 - 12 hours after the evening dose on the day of the colonoscopy. Colonoscopy was performed on Day 2, at least 3 hours and no more than 6 hours after the last dose of Fortrans®.
|
|---|---|---|
|
Mean Colonoscopy Duration
|
9.80 minutes
Standard Deviation 6.93
|
10.03 minutes
Standard Deviation 6.87
|
SECONDARY outcome
Timeframe: Colonoscopy was performed on Day 2.Population: The ITT population consisted of all randomised patients who received even a partial dose of study treatment. Patients were assessed according to the randomised treatment, regardless of treatment received. Only patients with data available are included.
Investigator satisfaction with the procedure was measured by the mean Likert scale score for global evaluation by the investigator. The Likert scale consists of 5 points, and ranges from 0 (poor cleansing) to 4 (excellent cleansing) as follows: * presence of faeces and soiled fluid: investigation could not be reliably performed = 0 * presence of faecal material and of unclear fluid, with negative effect on the reliability of the investigation = 1 * brown liquid, no solid faecal material, presence of unclear residual fluid that could be aspirated: no effect on the reliability of the investigation = 2 * absence of solid faecal material, presence of clear residual fluid = 3 * no faecal material, no residual fluid, empty colon = 4.
Outcome measures
| Measure |
Eziclen
n=145 Participants
Patients were randomised to receive an oral split-dose of Eziclen on Day 1 and Day 2. The first dose was taken the evening of Day 1 before the colonoscopy and the second dose was taken 10 - 12 hours after the evening dose on the day of the colonoscopy. Colonoscopy was performed on Day 2, at least 1 hour and no more than 6 hours after the last dose of Eziclen.
|
Fortrans®
n=148 Participants
Patients were randomised to receive an oral split-dose of Fortrans® on Day 1 and Day 2. The first dose was taken the evening of Day 1 before the colonoscopy and the second dose was taken 10 - 12 hours after the evening dose on the day of the colonoscopy. Colonoscopy was performed on Day 2, at least 3 hours and no more than 6 hours after the last dose of Fortrans®.
|
|---|---|---|
|
Investigator Satisfaction as Determined by Mean Likert Scale Score for Global Evaluation
|
3.03 units on a scale
Standard Deviation 0.61
|
2.93 units on a scale
Standard Deviation 0.72
|
SECONDARY outcome
Timeframe: Study treatment was administered as a split-dose on Days 1 and 2.Population: The ITT population consisted of all randomised patients who received even a partial dose of study treatment. Patients were assessed according to the randomised treatment, regardless of treatment received.
Patient compliance was evaluated based on the percentage of patients who consumed all the planned volume of the study treatment. A patient was considered compliant with the instructions of use provided in the prescription if he/she drank the whole preparation and any required further fluid intake. The percentage of compliant patients is presented.
Outcome measures
| Measure |
Eziclen
n=146 Participants
Patients were randomised to receive an oral split-dose of Eziclen on Day 1 and Day 2. The first dose was taken the evening of Day 1 before the colonoscopy and the second dose was taken 10 - 12 hours after the evening dose on the day of the colonoscopy. Colonoscopy was performed on Day 2, at least 1 hour and no more than 6 hours after the last dose of Eziclen.
|
Fortrans®
n=148 Participants
Patients were randomised to receive an oral split-dose of Fortrans® on Day 1 and Day 2. The first dose was taken the evening of Day 1 before the colonoscopy and the second dose was taken 10 - 12 hours after the evening dose on the day of the colonoscopy. Colonoscopy was performed on Day 2, at least 3 hours and no more than 6 hours after the last dose of Fortrans®.
|
|---|---|---|
|
Evaluation of Patient Compliance as Determined by the Percentage of Patients Who Consumed All the Planned Volume of Study Treatment
|
96.6 percentage of participants
|
84.5 percentage of participants
|
Adverse Events
Eziclen
Fortrans®
Serious adverse events
| Measure |
Eziclen
n=147 participants at risk
Patients were randomised to receive an oral split-dose of Eziclen on Day 1 and Day 2. The first dose was taken the evening of Day 1 before the colonoscopy and the second dose was taken 10 - 12 hours after the evening dose on the day of the colonoscopy. Colonoscopy was performed on Day 2, at least 1 hour and no more than 6 hours after the last dose of Eziclen.
|
Fortrans®
n=147 participants at risk
Patients were randomised to receive an oral split-dose of Fortrans® on Day 1 and Day 2. The first dose was taken the evening of Day 1 before the colonoscopy and the second dose was taken 10 - 12 hours after the evening dose on the day of the colonoscopy. Colonoscopy was performed on Day 2, at least 3 hours and no more than 6 hours after the last dose of Fortrans®.
|
|---|---|---|
|
Gastrointestinal disorders
Proctitis
|
0.68%
1/147 • Number of events 1 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to 30 +/- 3 days after colonoscopy (approximately 1 month).
AEs were actively collected by the investigator and patients were instructed to contact the investigator if they experienced any AEs. The safety population consisted of all randomised patients who received even a partial dose of study treatment. Patients were analysed according to the actual treatment received.
|
0.00%
0/147 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to 30 +/- 3 days after colonoscopy (approximately 1 month).
AEs were actively collected by the investigator and patients were instructed to contact the investigator if they experienced any AEs. The safety population consisted of all randomised patients who received even a partial dose of study treatment. Patients were analysed according to the actual treatment received.
|
Other adverse events
| Measure |
Eziclen
n=147 participants at risk
Patients were randomised to receive an oral split-dose of Eziclen on Day 1 and Day 2. The first dose was taken the evening of Day 1 before the colonoscopy and the second dose was taken 10 - 12 hours after the evening dose on the day of the colonoscopy. Colonoscopy was performed on Day 2, at least 1 hour and no more than 6 hours after the last dose of Eziclen.
|
Fortrans®
n=147 participants at risk
Patients were randomised to receive an oral split-dose of Fortrans® on Day 1 and Day 2. The first dose was taken the evening of Day 1 before the colonoscopy and the second dose was taken 10 - 12 hours after the evening dose on the day of the colonoscopy. Colonoscopy was performed on Day 2, at least 3 hours and no more than 6 hours after the last dose of Fortrans®.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
27.9%
41/147 • Number of events 66 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to 30 +/- 3 days after colonoscopy (approximately 1 month).
AEs were actively collected by the investigator and patients were instructed to contact the investigator if they experienced any AEs. The safety population consisted of all randomised patients who received even a partial dose of study treatment. Patients were analysed according to the actual treatment received.
|
12.9%
19/147 • Number of events 25 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to 30 +/- 3 days after colonoscopy (approximately 1 month).
AEs were actively collected by the investigator and patients were instructed to contact the investigator if they experienced any AEs. The safety population consisted of all randomised patients who received even a partial dose of study treatment. Patients were analysed according to the actual treatment received.
|
|
Gastrointestinal disorders
Abdominal distension
|
18.4%
27/147 • Number of events 38 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to 30 +/- 3 days after colonoscopy (approximately 1 month).
AEs were actively collected by the investigator and patients were instructed to contact the investigator if they experienced any AEs. The safety population consisted of all randomised patients who received even a partial dose of study treatment. Patients were analysed according to the actual treatment received.
|
12.9%
19/147 • Number of events 26 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to 30 +/- 3 days after colonoscopy (approximately 1 month).
AEs were actively collected by the investigator and patients were instructed to contact the investigator if they experienced any AEs. The safety population consisted of all randomised patients who received even a partial dose of study treatment. Patients were analysed according to the actual treatment received.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
8.8%
13/147 • Number of events 21 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to 30 +/- 3 days after colonoscopy (approximately 1 month).
AEs were actively collected by the investigator and patients were instructed to contact the investigator if they experienced any AEs. The safety population consisted of all randomised patients who received even a partial dose of study treatment. Patients were analysed according to the actual treatment received.
|
8.8%
13/147 • Number of events 16 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to 30 +/- 3 days after colonoscopy (approximately 1 month).
AEs were actively collected by the investigator and patients were instructed to contact the investigator if they experienced any AEs. The safety population consisted of all randomised patients who received even a partial dose of study treatment. Patients were analysed according to the actual treatment received.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.5%
11/147 • Number of events 15 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to 30 +/- 3 days after colonoscopy (approximately 1 month).
AEs were actively collected by the investigator and patients were instructed to contact the investigator if they experienced any AEs. The safety population consisted of all randomised patients who received even a partial dose of study treatment. Patients were analysed according to the actual treatment received.
|
6.1%
9/147 • Number of events 9 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to 30 +/- 3 days after colonoscopy (approximately 1 month).
AEs were actively collected by the investigator and patients were instructed to contact the investigator if they experienced any AEs. The safety population consisted of all randomised patients who received even a partial dose of study treatment. Patients were analysed according to the actual treatment received.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
12.2%
18/147 • Number of events 20 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to 30 +/- 3 days after colonoscopy (approximately 1 month).
AEs were actively collected by the investigator and patients were instructed to contact the investigator if they experienced any AEs. The safety population consisted of all randomised patients who received even a partial dose of study treatment. Patients were analysed according to the actual treatment received.
|
16.3%
24/147 • Number of events 25 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to 30 +/- 3 days after colonoscopy (approximately 1 month).
AEs were actively collected by the investigator and patients were instructed to contact the investigator if they experienced any AEs. The safety population consisted of all randomised patients who received even a partial dose of study treatment. Patients were analysed according to the actual treatment received.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
6.8%
10/147 • Number of events 11 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to 30 +/- 3 days after colonoscopy (approximately 1 month).
AEs were actively collected by the investigator and patients were instructed to contact the investigator if they experienced any AEs. The safety population consisted of all randomised patients who received even a partial dose of study treatment. Patients were analysed according to the actual treatment received.
|
6.8%
10/147 • Number of events 10 • Treatment emergent adverse events (TEAEs) were collected from Day 1 up to 30 +/- 3 days after colonoscopy (approximately 1 month).
AEs were actively collected by the investigator and patients were instructed to contact the investigator if they experienced any AEs. The safety population consisted of all randomised patients who received even a partial dose of study treatment. Patients were analysed according to the actual treatment received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee No publication of the Study Results shall be made without Sponsor's prior written approval. If a multi-centre publication is not submitted to a journal within 24 months after study conclusion at all sites the PI may individually publish results from the Institution Site subject to Sponsor's prior approval. Sponsor to be provided with final version of any abstract/presentation/paper prior to disclosure to provide scientific comments within 2 weeks for abstract/presentation or 6 weeks for article.
- Publication restrictions are in place
Restriction type: OTHER