Trial Outcomes & Findings for A Safety and Efficacy Comparison of BLI4700 Bowel Preparation Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy (NCT NCT03261960)
NCT ID: NCT03261960
Last Updated: 2021-09-08
Results Overview
% of subjects with successful bowel preparation rated by colonoscopist on a 4 point scale (1=poor to 4=excellent)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
389 participants
Primary outcome timeframe
Day of colonoscopy
Results posted on
2021-09-08
Participant Flow
Participant milestones
| Measure |
Experimental Arm
BLI4700 Bowel Preparation
BLI4700: Oral bowel preparation
|
Control Arm
FDA Approved Bowel Preparation
Magnesium bowel preparation: Oral bowel preparation
|
|---|---|---|
|
Overall Study
STARTED
|
190
|
199
|
|
Overall Study
COMPLETED
|
176
|
185
|
|
Overall Study
NOT COMPLETED
|
14
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Safety and Efficacy Comparison of BLI4700 Bowel Preparation Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy
Baseline characteristics by cohort
| Measure |
Experimental Arm
n=190 Participants
BLI4700 Bowel Preparation
BLI4700: Oral bowel preparation
|
Control Arm
n=199 Participants
FDA Approved Bowel Preparation
Magnesium bowel preparation: Oral bowel preparation
|
Total
n=389 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
128 Participants
n=99 Participants
|
152 Participants
n=107 Participants
|
280 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
62 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
109 Participants
n=206 Participants
|
|
Age, Continuous
|
58.2 years
STANDARD_DEVIATION 11.2 • n=99 Participants
|
57.3 years
STANDARD_DEVIATION 10.8 • n=107 Participants
|
57.8 years
STANDARD_DEVIATION 11.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
112 Participants
n=99 Participants
|
113 Participants
n=107 Participants
|
225 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
78 Participants
n=99 Participants
|
86 Participants
n=107 Participants
|
164 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
171 Participants
n=99 Participants
|
183 Participants
n=107 Participants
|
354 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
177 Participants
n=99 Participants
|
183 Participants
n=107 Participants
|
360 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
190 participants
n=99 Participants
|
199 participants
n=107 Participants
|
389 participants
n=206 Participants
|
|
Renal Insufficiency (GFR < 60)
|
16 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Diabetic
|
20 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day of colonoscopyPopulation: Efficacy population
% of subjects with successful bowel preparation rated by colonoscopist on a 4 point scale (1=poor to 4=excellent)
Outcome measures
| Measure |
Experimental Arm
n=190 Participants
BLI4700 Bowel Preparation
BLI4700: Oral bowel preparation
|
Control Arm
n=198 Participants
FDA Approved Bowel Preparation
Magnesium bowel preparation: Oral bowel preparation
|
|---|---|---|
|
Number and Percentage of Subjects With Successful Bowel Cleansing
|
175 Participants
|
174 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 daysPercentage of patients who reported abdominal pain (with associated severity) when directly queried by study personnel, out of all patients that reported that event.
Outcome measures
| Measure |
Experimental Arm
n=190 Participants
BLI4700 Bowel Preparation
BLI4700: Oral bowel preparation
|
Control Arm
n=199 Participants
FDA Approved Bowel Preparation
Magnesium bowel preparation: Oral bowel preparation
|
|---|---|---|
|
Abdominal Pain (Solicited Reports)
Mild
|
82 percentage of patients
|
100 percentage of patients
|
|
Abdominal Pain (Solicited Reports)
Moderate
|
16 percentage of patients
|
0 percentage of patients
|
|
Abdominal Pain (Solicited Reports)
Severe
|
2 percentage of patients
|
0 percentage of patients
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 daysPercentage of patients who reported abdominal distension (with associated severity) when directly queried by study personnel, out of all patients that reported that event.
Outcome measures
| Measure |
Experimental Arm
n=190 Participants
BLI4700 Bowel Preparation
BLI4700: Oral bowel preparation
|
Control Arm
n=199 Participants
FDA Approved Bowel Preparation
Magnesium bowel preparation: Oral bowel preparation
|
|---|---|---|
|
Abdominal Distension (Solicited Reports)
Mild
|
73 percentage of patients
|
69 percentage of patients
|
|
Abdominal Distension (Solicited Reports)
Moderate
|
27 percentage of patients
|
31 percentage of patients
|
|
Abdominal Distension (Solicited Reports)
Severe
|
0 percentage of patients
|
0 percentage of patients
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 daysPercentage of patients who reported nausea (with associated severity) when directly queried by study personnel, out of all patients that reported that event.
Outcome measures
| Measure |
Experimental Arm
n=190 Participants
BLI4700 Bowel Preparation
BLI4700: Oral bowel preparation
|
Control Arm
n=199 Participants
FDA Approved Bowel Preparation
Magnesium bowel preparation: Oral bowel preparation
|
|---|---|---|
|
Nausea (Solicited Reports)
Mild
|
74 percentage of patients
|
94 percentage of patients
|
|
Nausea (Solicited Reports)
Moderate
|
20 percentage of patients
|
6 percentage of patients
|
|
Nausea (Solicited Reports)
Severe
|
6 percentage of patients
|
0 percentage of patients
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 daysPercentage of patients who reported vomiting (with associated severity) when directly queried by study personnel, out of all patients that reported that event.
Outcome measures
| Measure |
Experimental Arm
n=190 Participants
BLI4700 Bowel Preparation
BLI4700: Oral bowel preparation
|
Control Arm
n=199 Participants
FDA Approved Bowel Preparation
Magnesium bowel preparation: Oral bowel preparation
|
|---|---|---|
|
Vomiting (Solicited Reports)
Mild
|
53 percentage of patients
|
33 percentage of patients
|
|
Vomiting (Solicited Reports)
Moderate
|
47 percentage of patients
|
67 percentage of patients
|
|
Vomiting (Solicited Reports)
Severe
|
0 percentage of patients
|
0 percentage of patients
|
Adverse Events
Experimental Arm
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Control Arm
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental Arm
n=190 participants at risk
BLI4700 Bowel Preparation
BLI4700: Oral bowel preparation
|
Control Arm
n=199 participants at risk
FDA Approved Bowel Preparation
Magnesium bowel preparation: Oral bowel preparation
|
|---|---|---|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/190 • 30 days
|
0.50%
1/199 • Number of events 1 • 30 days
|
Other adverse events
| Measure |
Experimental Arm
n=190 participants at risk
BLI4700 Bowel Preparation
BLI4700: Oral bowel preparation
|
Control Arm
n=199 participants at risk
FDA Approved Bowel Preparation
Magnesium bowel preparation: Oral bowel preparation
|
|---|---|---|
|
Investigations
Liver function test increased
|
2.6%
5/190 • Number of events 5 • 30 days
|
1.0%
2/199 • Number of events 2 • 30 days
|
Additional Information
Head of R&D, Gastroenterology
Braintree Laboratories, Inc.
Phone: 781-843-2202
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sole disclosure restriction which sponsor imposes on the PI is a sixty (60) day limited restriction in order to the protect potentially proprietary information which may be patentable
- Publication restrictions are in place
Restriction type: OTHER