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Completed

NCT Number: NCT03103581

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

The objective of this study is to evaluate the safety and efficacy of BLI4700 as a bowel preparation prior to colonoscopy in adult patients.

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Key information

Conditions

Age range

18 year and older

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.

Primary Inclusion Criteria:

  • Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication.
  • At least 18 years of age
  • If female, and of child-bearing potential, is using an acceptable form of birth control.
  • 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

Primary Exclusion Criteria:

  • Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.
  • 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 a prior history of renal, liver or cardiac insufficiency
  • 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.

Treatment and study plan

BLI4700

Drug

BLI4700 Bowel Preparation (Investigational Regimen)

Primary outcomes

  1. Proportion of Subjects With Successful Bowel Preparation

    Time frame: Day of colonoscopy

    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).

Sponsors and collaborators

Lead sponsor

Braintree Laboratories

Industry

Registry information

Official study title

A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 6, 2017
Registry last updated
Nov 15, 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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