Trial Outcomes & Findings for Study 301: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy (NCT NCT04446299)

NCT ID: NCT04446299

Last Updated: 2023-11-07

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: 519 participants
• Primary outcome timeframe: 2 days
• Results posted on: 2023-11-07

Participant Flow

Participant milestones

Measure	BLI4900 Experimental bowel preparation solution for oral ingestion Bowel Prep: Orally ingested liquid bowel preparation	FDA Approved Control FDA approved bowel preparation solution for oral ingestion Bowel Prep: Orally ingested liquid bowel preparation
Overall Study STARTED	259	260
Overall Study COMPLETED	220	230
Overall Study NOT COMPLETED	39	30

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study 301: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy

Baseline characteristics by cohort

Measure	BLI4900 n=259 Participants Experimental bowel preparation solution for oral ingestion Bowel Prep: Orally ingested liquid bowel preparation	FDA Approved Control n=260 Participants FDA approved bowel preparation solution for oral ingestion Bowel Prep: Orally ingested liquid bowel preparation	Total n=519 Participants Total of all reporting groups
Age, Continuous	55.9 years STANDARD_DEVIATION 11.4 • n=5 Participants	57.3 years STANDARD_DEVIATION 11.5 • n=7 Participants	56.6 years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	135 Participants n=5 Participants	148 Participants n=7 Participants	283 Participants n=5 Participants
Sex: Female, Male Male	124 Participants n=5 Participants	112 Participants n=7 Participants	236 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	21 Participants n=5 Participants	18 Participants n=7 Participants	39 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	238 Participants n=5 Participants	241 Participants n=7 Participants	479 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	7 Participants n=7 Participants	12 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	73 Participants n=5 Participants	69 Participants n=7 Participants	142 Participants n=5 Participants
Race (NIH/OMB) White	175 Participants n=5 Participants	182 Participants n=7 Participants	357 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	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	259 Participants n=5 Participants	260 Participants n=7 Participants	519 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 days

Population: Modified intent-to-treat population - subjects who took any portion of the study preparation and did not discontinue due to a reason other than safety, efficacy or tolerability.

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=232 Participants Experimental bowel preparation solution for oral ingestion Bowel Prep: Orally ingested liquid bowel preparation	FDA Approved Control n=239 Participants FDA approved bowel preparation solution for oral ingestion Bowel Prep: Orally ingested liquid bowel preparation
Proportion of Subjects With Successful Bowel Preparation	215 Participants	212 Participants

Adverse Events

BLI4900

Serious events: 1 serious events

Other events: 46 other events

Deaths: 0 deaths

FDA Approved Control

Serious events: 0 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Measure	BLI4900 n=233 participants at risk Experimental bowel preparation solution for oral ingestion Bowel Prep: Orally ingested liquid bowel preparation	FDA Approved Control n=243 participants at risk FDA approved bowel preparation solution for oral ingestion Bowel Prep: Orally ingested liquid bowel preparation
Infections and infestations COVID-19	0.43% 1/233 • 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.	0.00% 0/243 • 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=233 participants at risk Experimental bowel preparation solution for oral ingestion Bowel Prep: Orally ingested liquid bowel preparation	FDA Approved Control n=243 participants at risk FDA approved bowel preparation solution for oral ingestion Bowel Prep: Orally ingested liquid bowel preparation
Gastrointestinal disorders Nausea	12.9% 30/233 • 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.	9.1% 22/243 • 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 Abdominal distension	6.0% 14/233 • 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.	2.5% 6/243 • 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	5.6% 13/233 • 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.	2.9% 7/243 • 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 Abdominal Pain	3.0% 7/233 • 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.	3.7% 9/243 • 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	2.1% 5/233 • 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.	2.1% 5/243 • 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

Head of R&D, GI

Braintree Laboratories, Inc.

Phone: 7819646710

Email: studydirector@sebelapharma.com

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