Trial Outcomes & Findings for A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects (NCT NCT03023085)
NCT ID: NCT03023085
Last Updated: 2023-11-15
Results Overview
% of subjects with successful bowel preparation rated by blinded colonoscopist on a 4 point scale (1=poor, 2=fair, 3=good, 4 = excellent)
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
120 participants
Primary outcome timeframe
Day of colonoscopy
Results posted on
2023-11-15
Participant Flow
Participant milestones
| Measure |
BLI4700 (Study Formulation 1)
BLI4700 Bowel Preparation
BLI4700: BLI4700 tablet bowel preparation
|
BLI4700 (Study Formulation 2)
BLI4700 Bowel Preparation
BLI4700: BLI4700 tablet bowel preparation
|
BLI4700 (Study Formulation 3)
BLI4700 Bowel Preparation
BLI4700: BLI4700 tablet bowel preparation
|
BLI4700 (Study Formulation 4)
BLI4700 Bowel Preparation
BLI4700: BLI4700 tablet bowel preparation
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
40
|
37
|
17
|
20
|
|
Overall Study
COMPLETED
|
38
|
26
|
17
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
11
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects
Baseline characteristics by cohort
| Measure |
BLI4700 (Study Formulation 1)
n=40 Participants
BLI4700 Bowel Preparation
BLI4700: BLI4700 tablet bowel preparation
|
BLI4700 (Study Formulation 2)
n=37 Participants
BLI4700 Bowel Preparation
BLI4700: BLI4700 tablet bowel preparation
|
BLI4700 (Study Formulation 3)
n=17 Participants
BLI4700 Bowel Preparation
BLI4700: BLI4700 tablet bowel preparation
|
BLI4700 (Study Formulation 4)
n=20 Participants
BLI4700 Bowel Preparation
BLI4700: BLI4700 tablet bowel preparation
|
Total
n=114 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
59.2 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
59.8 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
58.3 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
56.6 years
STANDARD_DEVIATION 10.6 • n=4 Participants
|
58.8 years
STANDARD_DEVIATION 10.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
67 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
96 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
94 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
40 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
114 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day of colonoscopyPopulation: Efficacy population - all patients that took any portion of the preparation and did not discontinue from the study for a reason other than safety or efficacy.
% of subjects with successful bowel preparation rated by blinded colonoscopist on a 4 point scale (1=poor, 2=fair, 3=good, 4 = excellent)
Outcome measures
| Measure |
BLI4700 (Study Formulation 1)
n=40 Participants
BLI4700 Bowel Preparation
BLI4700: BLI4700 tablet bowel preparation
|
BLI4700 (Study Formulation 2)
n=37 Participants
BLI4700 Bowel Preparation
BLI4700: BLI4700 tablet bowel preparation
|
BLI4700 (Study Formulation 3)
n=17 Participants
BLI4700 Bowel Preparation
BLI4700: BLI4700 tablet bowel preparation
|
BLI4700 (Study Formulation 4)
n=20 Participants
BLI4700 Bowel Preparation
BLI4700: BLI4700 tablet bowel preparation
|
|---|---|---|---|---|
|
Number and Percentage of Subjects With Successful Bowel Cleansing
|
35 Participants
|
36 Participants
|
16 Participants
|
19 Participants
|
Adverse Events
BLI4700 (Study Formulation 1)
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
BLI4700 (Study Formulation 2)
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
BLI4700 (Study Formulation 3)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
BLI4700 (Study Formulation 4)
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BLI4700 (Study Formulation 1)
n=40 participants at risk
BLI4700 Bowel Preparation
BLI4700: BLI4700 tablet bowel preparation
|
BLI4700 (Study Formulation 2)
n=37 participants at risk
BLI4700 Bowel Preparation
BLI4700: BLI4700 tablet bowel preparation
|
BLI4700 (Study Formulation 3)
n=17 participants at risk
BLI4700 Bowel Preparation
BLI4700: BLI4700 tablet bowel preparation
|
BLI4700 (Study Formulation 4)
n=20 participants at risk
BLI4700 Bowel Preparation
BLI4700: BLI4700 tablet bowel preparation
|
|---|---|---|---|---|
|
Nervous system disorders
Syncope
|
0.00%
0/40 • 7 days
|
0.00%
0/37 • 7 days
|
0.00%
0/17 • 7 days
|
5.0%
1/20 • Number of events 1 • 7 days
|
Other adverse events
| Measure |
BLI4700 (Study Formulation 1)
n=40 participants at risk
BLI4700 Bowel Preparation
BLI4700: BLI4700 tablet bowel preparation
|
BLI4700 (Study Formulation 2)
n=37 participants at risk
BLI4700 Bowel Preparation
BLI4700: BLI4700 tablet bowel preparation
|
BLI4700 (Study Formulation 3)
n=17 participants at risk
BLI4700 Bowel Preparation
BLI4700: BLI4700 tablet bowel preparation
|
BLI4700 (Study Formulation 4)
n=20 participants at risk
BLI4700 Bowel Preparation
BLI4700: BLI4700 tablet bowel preparation
|
|---|---|---|---|---|
|
Vascular disorders
Hypotension
|
5.0%
2/40 • 7 days
|
0.00%
0/37 • 7 days
|
0.00%
0/17 • 7 days
|
0.00%
0/20 • 7 days
|
|
Nervous system disorders
Headache
|
2.5%
1/40 • 7 days
|
0.00%
0/37 • 7 days
|
0.00%
0/17 • 7 days
|
5.0%
1/20 • 7 days
|
|
General disorders
Chills
|
0.00%
0/40 • 7 days
|
0.00%
0/37 • 7 days
|
0.00%
0/17 • 7 days
|
5.0%
1/20 • 7 days
|
|
Gastrointestinal disorders
Nausea
|
47.5%
19/40 • 7 days
|
48.6%
18/37 • 7 days
|
52.9%
9/17 • 7 days
|
65.0%
13/20 • 7 days
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
10/40 • 7 days
|
16.2%
6/37 • 7 days
|
17.6%
3/17 • 7 days
|
20.0%
4/20 • 7 days
|
|
Gastrointestinal disorders
Abdominal Pain
|
22.5%
9/40 • 7 days
|
32.4%
12/37 • 7 days
|
17.6%
3/17 • 7 days
|
20.0%
4/20 • 7 days
|
|
Gastrointestinal disorders
Abdominal Distension
|
27.5%
11/40 • 7 days
|
48.6%
18/37 • 7 days
|
35.3%
6/17 • 7 days
|
40.0%
8/20 • 7 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