Trial Outcomes & Findings for A Safety and Efficacy Comparison of BLI4700 Bowel Prep Versus an FDA-approved Comparator in Adults Prior to Colonoscopy (NCT NCT03404401)
NCT ID: NCT03404401
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
620 participants
Primary outcome timeframe
Day of colonoscopy
Results posted on
2021-09-08
Participant Flow
Participant milestones
| Measure |
BLI4700 Bowel Preparation
BLI4700: Oral bowel preparation
|
FDA Approved Bowel Preparation
Polyethylene glycol bowel preparation: Oral bowel preparation
|
|---|---|---|
|
Overall Study
STARTED
|
281
|
271
|
|
Overall Study
COMPLETED
|
263
|
252
|
|
Overall Study
NOT COMPLETED
|
18
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Safety and Efficacy Comparison of BLI4700 Bowel Prep Versus an FDA-approved Comparator in Adults Prior to Colonoscopy
Baseline characteristics by cohort
| Measure |
BLI4700 Bowel Preparation
n=281 Participants
BLI4700: Oral bowel preparation
|
FDA Approved Bowel Preparation
n=271 Participants
Polyethylene glycol bowel preparation: Oral bowel preparation
|
Total
n=552 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
193 Participants
n=5 Participants
|
183 Participants
n=7 Participants
|
376 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
88 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
|
Age, Continuous
|
57.5 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
58.4 years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
57.9 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
158 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
310 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
123 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
242 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
27 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
254 Participants
n=5 Participants
|
240 Participants
n=7 Participants
|
494 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
43 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
221 Participants
n=5 Participants
|
212 Participants
n=7 Participants
|
433 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Diabetic
|
33 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
|
Renal Insufficiency (GFR < 60)
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 Participants
n=5 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 |
BLI4700 Bowel Preparation
n=278 Participants
BLI4700: Oral bowel preparation
|
FDA Approved Bowel Preparation
n=270 Participants
Polyethylene glycol bowel preparation: Oral bowel preparation
|
|---|---|---|
|
Number and Percentage of Subjects With Successful Bowel Cleansing
|
257 Participants
|
241 Participants
|
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 |
BLI4700 Bowel Preparation
n=281 Participants
BLI4700: Oral bowel preparation
|
FDA Approved Bowel Preparation
n=271 Participants
Polyethylene glycol bowel preparation: Oral bowel preparation
|
|---|---|---|
|
Abdominal Distension (Solicited Reports)
Mild
|
68 percentage of patients
|
71 percentage of patients
|
|
Abdominal Distension (Solicited Reports)
Moderate
|
30 percentage of patients
|
29 percentage of patients
|
|
Abdominal Distension (Solicited Reports)
Severe
|
1 percentage of patients
|
0 percentage of patients
|
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 |
BLI4700 Bowel Preparation
n=281 Participants
BLI4700: Oral bowel preparation
|
FDA Approved Bowel Preparation
n=271 Participants
Polyethylene glycol bowel preparation: Oral bowel preparation
|
|---|---|---|
|
Abdominal Pain (Solicited Reports)
Mild
|
65 percentage of patients
|
71 percentage of patients
|
|
Abdominal Pain (Solicited Reports)
Moderate
|
35 percentage of patients
|
29 percentage of patients
|
|
Abdominal Pain (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 |
BLI4700 Bowel Preparation
n=281 Participants
BLI4700: Oral bowel preparation
|
FDA Approved Bowel Preparation
n=271 Participants
Polyethylene glycol bowel preparation: Oral bowel preparation
|
|---|---|---|
|
Nausea (Solicited Reports)
Moderate
|
27 percentage of patients
|
23 percentage of patients
|
|
Nausea (Solicited Reports)
Mild
|
71 percentage of patients
|
77 percentage of patients
|
|
Nausea (Solicited Reports)
Severe
|
2 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 |
BLI4700 Bowel Preparation
n=281 Participants
BLI4700: Oral bowel preparation
|
FDA Approved Bowel Preparation
n=271 Participants
Polyethylene glycol bowel preparation: Oral bowel preparation
|
|---|---|---|
|
Vomiting (Solicited Reports)
Mild
|
48 percentage of patients
|
46 percentage of patients
|
|
Vomiting (Solicited Reports)
Moderate
|
52 percentage of patients
|
54 percentage of patients
|
|
Vomiting (Solicited Reports)
Severe
|
0 percentage of patients
|
0 percentage of patients
|
Adverse Events
BLI4700 Bowel Preparation
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
FDA Approved Bowel Preparation
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BLI4700 Bowel Preparation
n=281 participants at risk
BLI4700: Oral bowel preparation
|
FDA Approved Bowel Preparation
n=271 participants at risk
Polyethylene glycol bowel preparation: Oral bowel preparation
|
|---|---|---|
|
Injury, poisoning and procedural complications
wrist fracture
|
0.00%
0/281 • 30 days
|
0.37%
1/271 • Number of events 1 • 30 days
|
|
Infections and infestations
escherichia sepsis
|
0.00%
0/281 • 30 days
|
0.37%
1/271 • Number of events 1 • 30 days
|
|
Infections and infestations
pyelonephritis acute
|
0.00%
0/281 • 30 days
|
0.37%
1/271 • Number of events 1 • 30 days
|
Other adverse events
| Measure |
BLI4700 Bowel Preparation
n=281 participants at risk
BLI4700: Oral bowel preparation
|
FDA Approved Bowel Preparation
n=271 participants at risk
Polyethylene glycol bowel preparation: Oral bowel preparation
|
|---|---|---|
|
Nervous system disorders
dizziness
|
0.36%
1/281 • Number of events 1 • 30 days
|
1.5%
4/271 • Number of events 4 • 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