A Pilot Evaluation of BLI4900 Bowel Preparation in Adult Subjects

Phase 2

Completed

• Conditions: Colonoscopy
• Interventions: Drug: PEG Control; Drug: BLI4900

• Registration Number: NCT03328507
• Lead Sponsor: Braintree Laboratories

Brief Summary

The objective of this study is to evaluate the safety and efficacy of BLI4900 as a bowel preparation prior to colonoscopy in adult patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-30
• Study First Submitted QC: 2017-10-30
• Study First Posted: 2017-11-01
• Study Start: 2017-11-09
• Primary Completion: 2019-11-12
• Study Completion: 2019-11-12
• Disposition First Submitted: 2021-01-26
• Disposition First Submitted QC: 2021-01-26
• Disposition First Posted: 2021-01-28
• Status Verified: 2023-09
• Results First Submitted: 2023-09-29
• Results First Submitted QC: 2023-09-29
• Last Update Submitted: 2023-09-29
• Results First Posted: 2023-10-24
• Last Update Posted: 2023-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

Inclusion Criteria

• Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication.
• 18 to 85 years of age (inclusive).
• If female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, IUD, double-barrier method, depot contraceptive, abstinent, or vasectomized spouse).
• Negative urine pregnancy test at screening, if applicable.
• In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study.

Exclusion Criteria

• Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.
• Subjects with ongoing severe, acute inflammatory bowel disease.
• Subjects who had previous significant gastrointestinal surgeries.
• Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.
• Subjects with uncontrolled hypertension (systolic blood pressure > 170 mmHg and diastolic blood pressure > 100 mmHg).
• Subjects with severe renal insufficiency (GFR < 30 mL/min/1.73m2).
• Subjects with known severe hepatic insufficiency (Child Pugh C).
• Subjects with cardiac insufficiency (NYHA Functional Classifications 3 or 4).
• Subjects undergoing insulin therapy for any indication.
• Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
• Subjects undergoing colonoscopy for foreign body removal and/or decompression.
• Subjects who are pregnant or lactating, or intending to become pregnant during the study.
• Subjects of childbearing potential who refuse a pregnancy test.
• Subjects allergic to any preparation components.
• Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
• Subjects who have participated in an investigational surgical, drug, or device study within the past 30 days.
• Subjects who withdraw consent before completion of Visit 1 procedures.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
PEG Control	PEG Control	Polyethylene glycol-based bowel preparation
BLI4900	BLI4900	BLI4900 Bowel Preparation

Primary Outcome Measures

Name	Time	Method
% of Subjects With Successful Bowel Preparation	Day of colonoscopy	% of subjects with successful bowel preparation rated by blinded colonoscopist on a 4 point scale (1=poor to 4 = excellent)

Trial Locations

Locations (4)

Braintree Research Site 3; 🇺🇸 Chula Vista, California, United States

Braintree Research Site 1; 🇺🇸 Anaheim, California, United States

Braintree Clinical Research Site 2; 🇺🇸 Ogden, Utah, United States

Braintree Research Site 4; 🇺🇸 San Diego, California, United States