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Completed

NCT Number: NCT03328507

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.

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Key information

Conditions

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Braintree Research Site 1, Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BLI4900

Drug

BLI4900 Bowel Preparation

PEG Control

Drug

Polyethylene glycol-based bowel preparation

Primary outcomes

  1. % 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)

Sponsors and collaborators

Lead sponsor

Braintree Laboratories

Industry

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 1, 2017
Registry last updated
Oct 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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