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Clinical Trials/NCT03328507
NCT03328507CompletedPhase 2

A Pilot Evaluation of BLI4900 Bowel Preparation in Adult Subjects

Braintree Laboratories4 sites in 1 country121 target enrollmentStarted: November 9, 2017Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
121
Locations
4
Primary Endpoint
% of Subjects With Successful Bowel Preparation

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Sequential
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

BLI4900

Experimental

BLI4900 Bowel Preparation

Intervention: BLI4900 (Drug)

PEG Control

Active Comparator

Polyethylene glycol-based bowel preparation

Intervention: PEG Control (Drug)

Outcomes

Primary Outcomes

% of Subjects With Successful Bowel Preparation

Time Frame: Day of colonoscopy

% of subjects with successful bowel preparation rated by blinded colonoscopist on a 4 point scale (1=poor to 4 = excellent)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Braintree Laboratories
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (4)

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