Trial Outcomes & Findings for BLI4700-202: A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects (NCT NCT03103581)

Last Updated: 2023-11-15

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

PHASE2

Target enrollment

17 participants

Primary outcome timeframe

Day of colonoscopy

Results posted on

2023-11-15

Participant Flow

The study protocol allowed for the evaluation of multiple formulations of BLI4700, however only a single formulation was evaluated in the trial. All data for that formulation is presented in a single arm.

Participant milestones

Participant milestones
Measure	BLI4700 BLI4700 Bowel Preparation (Investigational Regimen) BLI4700: BLI4700 Bowel Preparation (Investigational Regimen)
Overall Study STARTED	17
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

BLI4700-202: A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BLI4700 n=17 Participants BLI4700 Bowel Preparation (Investigational Regimen) BLI4700: BLI4700 Bowel Preparation (Investigational Regimen)
Age, Continuous	47.9 years STANDARD_DEVIATION 13.1 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day of colonoscopy

Population: The study protocol allowed for the evaluation of multiple formulations of BLI4700, however only a single formulation was evaluated in the trial. All data for that formulation is presented in a single arm.

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

Outcome measures
Measure	BLI4700 n=17 Participants BLI4700 Bowel Preparation (Investigational Regimen) BLI4700: BLI4700 Bowel Preparation (Investigational Regimen)
Proportion of Subjects With Successful Bowel Preparation	15 Participants

Adverse Events

BLI4700

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	BLI4700 n=17 participants at risk BLI4700 Bowel Preparation (Investigational Regimen) BLI4700: BLI4700 Bowel Preparation (Investigational Regimen)
Gastrointestinal disorders abdominal distension	58.8% 10/17 • 2 days The study protocol allowed for the evaluation of multiple formulations of BLI4700, however only a single formulation was evaluated in the trial. All data for that formulation is presented in a single arm.
Gastrointestinal disorders abdominal pain	5.9% 1/17 • 2 days The study protocol allowed for the evaluation of multiple formulations of BLI4700, however only a single formulation was evaluated in the trial. All data for that formulation is presented in a single arm.
Gastrointestinal disorders abdominal pain upper	23.5% 4/17 • 2 days The study protocol allowed for the evaluation of multiple formulations of BLI4700, however only a single formulation was evaluated in the trial. All data for that formulation is presented in a single arm.
Gastrointestinal disorders nausea	47.1% 8/17 • 2 days The study protocol allowed for the evaluation of multiple formulations of BLI4700, however only a single formulation was evaluated in the trial. All data for that formulation is presented in a single arm.
Gastrointestinal disorders vomiting	35.3% 6/17 • 2 days The study protocol allowed for the evaluation of multiple formulations of BLI4700, however only a single formulation was evaluated in the trial. All data for that formulation is presented in a single arm.

Additional Information

Head of R&D, GI

Braintree Laboratories, Inc.

Phone: 7818432202

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