Trial Outcomes & Findings for A Pilot Evaluation of BLI4900 Bowel Preparation in Adult Subjects (NCT NCT03328507)
NCT ID: NCT03328507
Last Updated: 2023-10-24
Results Overview
% of subjects with successful bowel preparation rated by blinded colonoscopist on a 4 point scale (1=poor to 4 = excellent)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
121 participants
Primary outcome timeframe
Day of colonoscopy
Results posted on
2023-10-24
Participant Flow
Participant milestones
| Measure |
BLI4900-3
Formulation 3
|
BLI4900-5
Formulation 5
|
BLI4900-6
Formulation 6
|
PEG-SD
Polyethylene glycol 3350 mixed with sports drink (plus bisacodyl)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
21
|
40
|
41
|
19
|
|
Overall Study
COMPLETED
|
21
|
40
|
40
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pilot Evaluation of BLI4900 Bowel Preparation in Adult Subjects
Baseline characteristics by cohort
| Measure |
BLI4900-3
n=21 Participants
Formulation 3
|
BLI4900-5
n=40 Participants
Formulation 5
|
BLI4900-6
n=40 Participants
Formulation 6
|
PEG-SD
n=19 Participants
Polyethylene glycol 3350 mixed with sports drink (plus bisacodyl)
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
54.8 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
54.5 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
58.7 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
49.7 years
STANDARD_DEVIATION 15.7 • n=4 Participants
|
55.2 years
STANDARD_DEVIATION 12.0 • n=21 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
66 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
92 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
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
98 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
|
21 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
120 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day of colonoscopy% of subjects with successful bowel preparation rated by blinded colonoscopist on a 4 point scale (1=poor to 4 = excellent)
Outcome measures
| Measure |
BLI4900-3
n=21 Participants
Formulation 3
|
BLI4900-5
n=40 Participants
Formulation 5
|
BLI4900-6
n=40 Participants
Formulation 6
|
PEG-SD
n=19 Participants
Polyethylene glycol 3350 mixed with sports drink (plus bisacodyl)
|
|---|---|---|---|---|
|
% of Subjects With Successful Bowel Preparation
|
17 Participants
|
37 Participants
|
37 Participants
|
16 Participants
|
Adverse Events
BLI4900-3
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
BLI4900-5
Serious events: 0 serious events
Other events: 31 other events
Deaths: 0 deaths
BLI4900-6
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
PEG-SD
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BLI4900-3
n=21 participants at risk
Formulation 3
|
BLI4900-5
n=40 participants at risk
Formulation 5
|
BLI4900-6
n=41 participants at risk
Formulation 6
|
PEG-SD
n=19 participants at risk
Polyethylene glycol 3350 mixed with sports drink (plus bisacodyl)
|
|---|---|---|---|---|
|
Gastrointestinal disorders
diverticulitis
|
0.00%
0/21 • 2 days
|
0.00%
0/40 • 2 days
|
0.00%
0/41 • 2 days
|
5.3%
1/19 • 2 days
|
Other adverse events
| Measure |
BLI4900-3
n=21 participants at risk
Formulation 3
|
BLI4900-5
n=40 participants at risk
Formulation 5
|
BLI4900-6
n=41 participants at risk
Formulation 6
|
PEG-SD
n=19 participants at risk
Polyethylene glycol 3350 mixed with sports drink (plus bisacodyl)
|
|---|---|---|---|---|
|
Gastrointestinal disorders
abdominal distension
|
52.4%
11/21 • 2 days
|
65.0%
26/40 • 2 days
|
19.5%
8/41 • 2 days
|
52.6%
10/19 • 2 days
|
|
Gastrointestinal disorders
abdominal pain upper
|
33.3%
7/21 • 2 days
|
42.5%
17/40 • 2 days
|
14.6%
6/41 • 2 days
|
26.3%
5/19 • 2 days
|
|
Gastrointestinal disorders
nausea
|
33.3%
7/21 • 2 days
|
47.5%
19/40 • 2 days
|
12.2%
5/41 • 2 days
|
36.8%
7/19 • 2 days
|
|
Gastrointestinal disorders
vomiting
|
14.3%
3/21 • 2 days
|
5.0%
2/40 • 2 days
|
7.3%
3/41 • 2 days
|
5.3%
1/19 • 2 days
|
|
Metabolism and nutrition disorders
hypernatremia
|
0.00%
0/21 • 2 days
|
0.00%
0/40 • 2 days
|
0.00%
0/41 • 2 days
|
5.3%
1/19 • 2 days
|
|
Nervous system disorders
headache
|
9.5%
2/21 • 2 days
|
0.00%
0/40 • 2 days
|
0.00%
0/41 • 2 days
|
0.00%
0/19 • 2 days
|
|
Nervous system disorders
migraine
|
4.8%
1/21 • 2 days
|
0.00%
0/40 • 2 days
|
0.00%
0/41 • 2 days
|
0.00%
0/19 • 2 days
|
|
Vascular disorders
orthostatic hypotension
|
4.8%
1/21 • 2 days
|
2.5%
1/40 • 2 days
|
0.00%
0/41 • 2 days
|
0.00%
0/19 • 2 days
|
Additional Information
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