Trial Outcomes & Findings for Investigation of PICOPREP and PEG-ELS for Bowel Preparation for Colonoscopy (NCT NCT01356407)
NCT ID: NCT01356407
Last Updated: 2013-01-28
Results Overview
The total Ottawa Bowel Preparation Scale (OBPS) score, rated by the treatment-blinded Investigator at colonoscopy, was designed to evaluate cleanliness of the colon by grading the endoscopic visibility of the mucosa according to a scale from 0 ('excellent' visibility) to 4 ('inadequate' visibility); The component scores for each of the colon segment are added together, along with an overall 'fluid' score (from small amount = 0, to large amount = 2). Thus, the total OBPS has a range from 0 (a perfect preparation) to 14 (a completely unprepared bowel)
COMPLETED
PHASE3
300 participants
day 2
2013-01-28
Participant Flow
325 subjects were screened and 300 subjects were randomized at 7 sites in China.
Participant milestones
| Measure |
PICOPREP
"Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy.
|
Hengkang Zhengqing (PEG-ELS)
PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
|
|---|---|---|
|
Overall Study
STARTED
|
150
|
150
|
|
Overall Study
COMPLETED
|
144
|
146
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
| Measure |
PICOPREP
"Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy.
|
Hengkang Zhengqing (PEG-ELS)
PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Patient Withdrew Consent
|
2
|
1
|
|
Overall Study
Could not afford IMP administration
|
0
|
1
|
|
Overall Study
Not complete Endoscopy
|
2
|
2
|
Baseline Characteristics
Investigation of PICOPREP and PEG-ELS for Bowel Preparation for Colonoscopy
Baseline characteristics by cohort
| Measure |
PICOPREP
n=150 Participants
"Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy.
|
Hengkang Zhengqing (PEG-ELS)
n=150 Participants
PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
46.44 years
STANDARD_DEVIATION 12.88 • n=93 Participants
|
47.15 years
STANDARD_DEVIATION 12.63 • n=4 Participants
|
46.80 years
STANDARD_DEVIATION 12.74 • n=27 Participants
|
|
Sex: Female, Male
Female
|
86 Participants
n=93 Participants
|
73 Participants
n=4 Participants
|
159 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=93 Participants
|
77 Participants
n=4 Participants
|
141 Participants
n=27 Participants
|
|
Weight
|
62.35 kilograms
STANDARD_DEVIATION 10.20 • n=93 Participants
|
62.95 kilograms
STANDARD_DEVIATION 10.86 • n=4 Participants
|
62.65 kilograms
STANDARD_DEVIATION 10.52 • n=27 Participants
|
|
BMI
|
22.91 kg/m2
STANDARD_DEVIATION 2.67 • n=93 Participants
|
23.07 kg/m2
STANDARD_DEVIATION 2.83 • n=4 Participants
|
22.99 kg/m2
STANDARD_DEVIATION 2.75 • n=27 Participants
|
PRIMARY outcome
Timeframe: day 2Population: Full Analysis Set (FAS) All randomised patients who have received at least one dose of the study drug and have evaluable data from the Ottawa Bowel Preparation Scale (OBPS) will form the Full Analysis Set.
The total Ottawa Bowel Preparation Scale (OBPS) score, rated by the treatment-blinded Investigator at colonoscopy, was designed to evaluate cleanliness of the colon by grading the endoscopic visibility of the mucosa according to a scale from 0 ('excellent' visibility) to 4 ('inadequate' visibility); The component scores for each of the colon segment are added together, along with an overall 'fluid' score (from small amount = 0, to large amount = 2). Thus, the total OBPS has a range from 0 (a perfect preparation) to 14 (a completely unprepared bowel)
Outcome measures
| Measure |
PICOPREP
n=144 Participants
"Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy.
|
Hengkang Zhengqing (PEG-ELS)
n=146 Participants
PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
|
|---|---|---|
|
The Ottawa Scale Score of Patients Who Had Successfully Completed the Colonoscopy Examination After Having Completed the Study Bowel Preparation
|
4.73 units on a scale
Standard Deviation 2.48
|
4.91 units on a scale
Standard Deviation 2.42
|
SECONDARY outcome
Timeframe: Day 2Population: Full Analysis Set (FAS) All randomised patients who have received at least one dose of the study drug and have evaluable data from the Ottawa Bowel Preparation Scale (OBPS) will form the Full Analysis Set
On the day of the procedure, but before colonoscopy or any sedation for colonoscopy, subjects were asked to complete a standardised questionnaire regarding whether or not complete the IMP (yes or no), ease of taking IMP (rating from 1 point(very easy) to 5 point (very difficult)), degree of acceptability to study med (rating from 1 point (excellent) to 5 point (bad)), palatability of IMP (rating from 1 point (excellent) to 5 point (bad)) and tolerability (5 adverse reactions including abdominal bloating, spasms, nausea, vomiting and general malaise which were generally reported in bowel preparation with rating according to intensity from 1 point (None) to 4 point (Severe)).
Outcome measures
| Measure |
PICOPREP
n=144 Participants
"Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy.
|
Hengkang Zhengqing (PEG-ELS)
n=146 Participants
PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
|
|---|---|---|
|
Patient Response to Acceptability and Tolerability Questionnaire
Abdominal Bloating
|
1.31 units on a scale
Standard Deviation 0.48
|
1.45 units on a scale
Standard Deviation 0.72
|
|
Patient Response to Acceptability and Tolerability Questionnaire
Spasms
|
1.13 units on a scale
Standard Deviation 0.41
|
1.12 units on a scale
Standard Deviation 0.42
|
|
Patient Response to Acceptability and Tolerability Questionnaire
Nausea
|
1.22 units on a scale
Standard Deviation 0.45
|
1.64 units on a scale
Standard Deviation 0.77
|
|
Patient Response to Acceptability and Tolerability Questionnaire
Vomiting
|
1.03 units on a scale
Standard Deviation 0.22
|
1.25 units on a scale
Standard Deviation 0.55
|
|
Patient Response to Acceptability and Tolerability Questionnaire
General Malaise
|
1.31 units on a scale
Standard Deviation 0.48
|
1.60 units on a scale
Standard Deviation 0.68
|
|
Patient Response to Acceptability and Tolerability Questionnaire
Ease of Taking Study Medication
|
1.52 units on a scale
Standard Deviation 0.73
|
2.08 units on a scale
Standard Deviation 0.87
|
|
Patient Response to Acceptability and Tolerability Questionnaire
Degree of Acceptability to Study Med
|
1.46 units on a scale
Standard Deviation 0.65
|
2.15 units on a scale
Standard Deviation 0.88
|
|
Patient Response to Acceptability and Tolerability Questionnaire
Palatability of Study Medication
|
1.64 units on a scale
Standard Deviation 0.76
|
2.62 units on a scale
Standard Deviation 0.92
|
SECONDARY outcome
Timeframe: Day 2Population: All randomized patients who have received at least one dose of the study drug and have evaluable data from the Ottawa Bowel Preparation Scale (OBPS) will form the Full Analysis Set.
Mean Ottawa Scale scores, and score categories (from 'excellent' to 'bad'), are summarised by colon segment together with the overall fluid content score
Outcome measures
| Measure |
PICOPREP
n=144 Participants
"Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy.
|
Hengkang Zhengqing (PEG-ELS)
n=146 Participants
PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
|
|---|---|---|
|
Ottawa Scale Score by Colon Segment
Ascending
|
1.56 units on a scale
Standard Deviation 0.91
|
1.73 units on a scale
Standard Deviation 0.97
|
|
Ottawa Scale Score by Colon Segment
Transverse/descending
|
1.43 units on a scale
Standard Deviation 0.87
|
1.33 units on a scale
Standard Deviation 0.88
|
|
Ottawa Scale Score by Colon Segment
Rectosigmoid
|
1.25 units on a scale
Standard Deviation 0.90
|
1.23 units on a scale
Standard Deviation 0.92
|
|
Ottawa Scale Score by Colon Segment
Overall fluid content (score)
|
0.49 units on a scale
Standard Deviation 0.61
|
0.62 units on a scale
Standard Deviation 0.64
|
SECONDARY outcome
Timeframe: Day 2Population: Full Analysis Set (FAS) All randomised patients who have received at least one dose of the study drug and have evaluable data from the Ottawa Bowel Preparation Scale (OBPS) will form the Full Analysis Set.
An overview of completion rates of colonoscopy (i.e., endoscope reaching the ileocecal valve)
Outcome measures
| Measure |
PICOPREP
n=144 Participants
"Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy.
|
Hengkang Zhengqing (PEG-ELS)
n=146 Participants
PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
|
|---|---|---|
|
Percentage of Successful Completion of Colonoscopy
No
|
0 Percentage of Subjects (%)
|
0 Percentage of Subjects (%)
|
|
Percentage of Successful Completion of Colonoscopy
Yes
|
100 Percentage of Subjects (%)
|
100 Percentage of Subjects (%)
|
SECONDARY outcome
Timeframe: Day 2Population: Full Analysis Set (FAS) All randomised patients who have received at least one dose of the study drug and have evaluable data from the Ottawa Bowel Preparation Scale (OBPS) will form the Full Analysis Set.
At colonoscopy, bowel preparations were rated by the treatment-blinded endoscopist, as being of an overall quality "adequate for clinical diagnostic purposes" (Y/N). The total Ottawa Scale scores was correlated with 'adequate' or 'inadequate' quality of bowel preparation for clinical diagnostic purposes
Outcome measures
| Measure |
PICOPREP
n=144 Participants
"Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy.
|
Hengkang Zhengqing (PEG-ELS)
n=146 Participants
PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
|
|---|---|---|
|
Proportion of Successful Colonoscopies in the Clinical Setting (Predicted by Ottawa Scale Score)
Adequate bowel preparation
|
4.54 units on a scale
Standard Deviation 2.27
|
4.63 units on a scale
Standard Deviation 2.20
|
|
Proportion of Successful Colonoscopies in the Clinical Setting (Predicted by Ottawa Scale Score)
Inadequate bowel preparation
|
10.00 units on a scale
Standard Deviation 2.35
|
9.22 units on a scale
Standard Deviation 1.20
|
SECONDARY outcome
Timeframe: Day 2Population: Full Analysis Set (FAS) All randomised patients who have received at least one dose of the study drug and have evaluable data from the Ottawa Bowel Preparation Scale (OBPS) will form the Full Analysis Set.
The Proportion of subjects requiring a repeat colonoscopy due to poor bowel preparation
Outcome measures
| Measure |
PICOPREP
n=144 Participants
"Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy.
|
Hengkang Zhengqing (PEG-ELS)
n=146 Participants
PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
|
|---|---|---|
|
Proportion of Subjects Requiring a Repeat Colonoscopy Due to Poor Bowel Preparation
No
|
139 participants
|
137 participants
|
|
Proportion of Subjects Requiring a Repeat Colonoscopy Due to Poor Bowel Preparation
Yes
|
5 participants
|
9 participants
|
Adverse Events
PICOPREP
Hengkang Zhengqing (PEG-ELS)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PICOPREP
n=146 participants at risk
"Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy.
|
Hengkang Zhengqing (PEG-ELS)
n=149 participants at risk
PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
|
|---|---|---|
|
General disorders
General disorders
|
61.6%
90/146 • Number of events 136
Safety Set (SS) All randomised patients that received at least one dose of the study drug and completed at least one post-treatment safety assessment are part of the Safety Set of this study. The Safety Set will be used for safety assessment in this study.
|
79.9%
119/149 • Number of events 212
Safety Set (SS) All randomised patients that received at least one dose of the study drug and completed at least one post-treatment safety assessment are part of the Safety Set of this study. The Safety Set will be used for safety assessment in this study.
|
|
General disorders
Abdominal Distension
|
44.5%
65/146 • Number of events 65
Safety Set (SS) All randomised patients that received at least one dose of the study drug and completed at least one post-treatment safety assessment are part of the Safety Set of this study. The Safety Set will be used for safety assessment in this study.
|
49.7%
74/149 • Number of events 74
Safety Set (SS) All randomised patients that received at least one dose of the study drug and completed at least one post-treatment safety assessment are part of the Safety Set of this study. The Safety Set will be used for safety assessment in this study.
|
|
General disorders
Nausea
|
19.9%
29/146 • Number of events 29
Safety Set (SS) All randomised patients that received at least one dose of the study drug and completed at least one post-treatment safety assessment are part of the Safety Set of this study. The Safety Set will be used for safety assessment in this study.
|
49.0%
73/149 • Number of events 73
Safety Set (SS) All randomised patients that received at least one dose of the study drug and completed at least one post-treatment safety assessment are part of the Safety Set of this study. The Safety Set will be used for safety assessment in this study.
|
|
General disorders
Abdominal pain
|
21.2%
31/146 • Number of events 31
Safety Set (SS) All randomised patients that received at least one dose of the study drug and completed at least one post-treatment safety assessment are part of the Safety Set of this study. The Safety Set will be used for safety assessment in this study.
|
18.8%
28/149 • Number of events 28
Safety Set (SS) All randomised patients that received at least one dose of the study drug and completed at least one post-treatment safety assessment are part of the Safety Set of this study. The Safety Set will be used for safety assessment in this study.
|
|
General disorders
Vomiting
|
4.1%
6/146 • Number of events 6
Safety Set (SS) All randomised patients that received at least one dose of the study drug and completed at least one post-treatment safety assessment are part of the Safety Set of this study. The Safety Set will be used for safety assessment in this study.
|
21.5%
32/149 • Number of events 32
Safety Set (SS) All randomised patients that received at least one dose of the study drug and completed at least one post-treatment safety assessment are part of the Safety Set of this study. The Safety Set will be used for safety assessment in this study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60