Trial Outcomes & Findings for Study 302: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy (NCT NCT04446312)
NCT ID: NCT04446312
Last Updated: 2023-10-27
Results Overview
Successful bowel preparation is defined as a preparation rated as Excellent or Good by the blinded endoscopist on a 4 point scale (Excellent, Good, Fair, Poor).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
500 participants
Primary outcome timeframe
2 days
Results posted on
2023-10-27
Participant Flow
Participant milestones
| Measure |
BLI4900
Experimental bowel preparation solution for oral ingestion
Bowel Prep (powder for oral solution): Orally ingested liquid bowel preparation (1 liter per dose)
|
FDA Approved Control
FDA approved bowel preparation solution for oral ingestion
Bowel Prep (liquid for reconstitution): Orally ingested liquid bowel preparation (16 oz per dose)
|
|---|---|---|
|
Overall Study
STARTED
|
250
|
250
|
|
Overall Study
COMPLETED
|
212
|
206
|
|
Overall Study
NOT COMPLETED
|
38
|
44
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study 302: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy
Baseline characteristics by cohort
| Measure |
BLI4900
n=250 Participants
Experimental bowel preparation solution for oral ingestion
Bowel Prep: Orally ingested liquid bowel preparation
|
FDA Approved Control
n=250 Participants
FDA approved bowel preparation solution for oral ingestion
Bowel Prep: Orally ingested liquid bowel preparation
|
Total
n=500 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.4 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
56.1 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
56.2 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
142 Participants
n=5 Participants
|
152 Participants
n=7 Participants
|
294 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
108 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
206 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
55 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
195 Participants
n=5 Participants
|
202 Participants
n=7 Participants
|
397 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
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
15 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
26 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
209 Participants
n=5 Participants
|
213 Participants
n=7 Participants
|
422 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
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
250 Participants
n=5 Participants
|
250 Participants
n=7 Participants
|
500 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 daysPopulation: Modified intent-to-treat population - this population includes all subjects that took any portion of study preparation and who did not withdraw for a reason other than safety, efficacy or tolerance.
Successful bowel preparation is defined as a preparation rated as Excellent or Good by the blinded endoscopist on a 4 point scale (Excellent, Good, Fair, Poor).
Outcome measures
| Measure |
BLI4900
n=226 Participants
Experimental bowel preparation solution for oral ingestion
Bowel Prep: Orally ingested liquid bowel preparation
|
FDA Approved Control
n=224 Participants
FDA approved bowel preparation solution for oral ingestion
Bowel Prep: Orally ingested liquid bowel preparation
|
|---|---|---|
|
Proportion of Subjects With Successful Bowel Preparation
|
212 Participants
|
211 Participants
|
Adverse Events
BLI4900
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
FDA Approved Control
Serious events: 2 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BLI4900
n=227 participants at risk
Experimental bowel preparation solution for oral ingestion
Bowel Prep: Orally ingested liquid bowel preparation
|
FDA Approved Control
n=226 participants at risk
FDA approved bowel preparation solution for oral ingestion
Bowel Prep: Orally ingested liquid bowel preparation
|
|---|---|---|
|
Nervous system disorders
concussion
|
0.00%
0/227 • 30 days
The Analysis Population for adverse event reporting, including serious adverse events and all cause mortality, is the Safety Population which includes all patients that took any portion of the study preparation. This population differs from the Baseline Population because some patients that were dispensed a study preparation did not take it.
|
0.44%
1/226 • Number of events 1 • 30 days
The Analysis Population for adverse event reporting, including serious adverse events and all cause mortality, is the Safety Population which includes all patients that took any portion of the study preparation. This population differs from the Baseline Population because some patients that were dispensed a study preparation did not take it.
|
|
Infections and infestations
COVID-19
|
0.00%
0/227 • 30 days
The Analysis Population for adverse event reporting, including serious adverse events and all cause mortality, is the Safety Population which includes all patients that took any portion of the study preparation. This population differs from the Baseline Population because some patients that were dispensed a study preparation did not take it.
|
0.44%
1/226 • Number of events 1 • 30 days
The Analysis Population for adverse event reporting, including serious adverse events and all cause mortality, is the Safety Population which includes all patients that took any portion of the study preparation. This population differs from the Baseline Population because some patients that were dispensed a study preparation did not take it.
|
|
Gastrointestinal disorders
rectal hemorrhage
|
0.00%
0/227 • 30 days
The Analysis Population for adverse event reporting, including serious adverse events and all cause mortality, is the Safety Population which includes all patients that took any portion of the study preparation. This population differs from the Baseline Population because some patients that were dispensed a study preparation did not take it.
|
0.44%
1/226 • Number of events 1 • 30 days
The Analysis Population for adverse event reporting, including serious adverse events and all cause mortality, is the Safety Population which includes all patients that took any portion of the study preparation. This population differs from the Baseline Population because some patients that were dispensed a study preparation did not take it.
|
Other adverse events
| Measure |
BLI4900
n=227 participants at risk
Experimental bowel preparation solution for oral ingestion
Bowel Prep: Orally ingested liquid bowel preparation
|
FDA Approved Control
n=226 participants at risk
FDA approved bowel preparation solution for oral ingestion
Bowel Prep: Orally ingested liquid bowel preparation
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
6.6%
15/227 • 30 days
The Analysis Population for adverse event reporting, including serious adverse events and all cause mortality, is the Safety Population which includes all patients that took any portion of the study preparation. This population differs from the Baseline Population because some patients that were dispensed a study preparation did not take it.
|
6.2%
14/226 • 30 days
The Analysis Population for adverse event reporting, including serious adverse events and all cause mortality, is the Safety Population which includes all patients that took any portion of the study preparation. This population differs from the Baseline Population because some patients that were dispensed a study preparation did not take it.
|
|
Gastrointestinal disorders
Vomiting
|
3.5%
8/227 • 30 days
The Analysis Population for adverse event reporting, including serious adverse events and all cause mortality, is the Safety Population which includes all patients that took any portion of the study preparation. This population differs from the Baseline Population because some patients that were dispensed a study preparation did not take it.
|
7.1%
16/226 • 30 days
The Analysis Population for adverse event reporting, including serious adverse events and all cause mortality, is the Safety Population which includes all patients that took any portion of the study preparation. This population differs from the Baseline Population because some patients that were dispensed a study preparation did not take it.
|
|
Nervous system disorders
Headache
|
1.8%
4/227 • 30 days
The Analysis Population for adverse event reporting, including serious adverse events and all cause mortality, is the Safety Population which includes all patients that took any portion of the study preparation. This population differs from the Baseline Population because some patients that were dispensed a study preparation did not take it.
|
1.8%
4/226 • 30 days
The Analysis Population for adverse event reporting, including serious adverse events and all cause mortality, is the Safety Population which includes all patients that took any portion of the study preparation. This population differs from the Baseline Population because some patients that were dispensed a study preparation did not take it.
|
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