A Pilot Evaluation of BLI4900 Bowel Preparation in Adult Subjects

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

Study Overview

• Status: Completed
• Conditions: Colonoscopy
• Intervention / Treatment: Drug: BLI4900; Drug: PEG Control

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Braintree Research Site 1
    • Chula Vista, California, United States, 91910
      • Braintree Research Site 3
    • San Diego, California, United States, 92114
      • Braintree Research Site 4
  • Utah
    • Ogden, Utah, United States, 84405
      • Braintree Clinical Research Site 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BLI4900; BLI4900 Bowel Preparation	Drug: BLI4900; BLI4900 Bowel Preparation
Active Comparator: PEG Control; Polyethylene glycol-based bowel preparation	Drug: PEG Control; Polyethylene glycol-based bowel preparation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Frequency of adverse events	7 days

Collaborators and Investigators

• Sponsor: Braintree Laboratories
• Investigators: Study Director: John McGowan, MPH, Braintree Laboratories, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2017
• Primary Completion (Actual): November 12, 2019
• Study Completion (Actual): November 12, 2019

Study Registration Dates

• First Submitted: October 30, 2017
• First Submitted That Met QC Criteria: October 30, 2017
• First Posted (Actual): November 1, 2017

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: September 29, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: BLI4900-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No