Skip to main content
OpenTrials
Completed

NCT Number: NCT01501513

A Safety Study of 3 Different Bowel Cleansing Preparations

The objective of this study is to compare the safety, tolerance and efficacy of BLI800 (approved and investigational regimens) to an approved control preparation as bowel preparations prior to colonoscopy in adult patients, particularly including the elderly and those with renal and/or hepatic impairment.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of South Alabama, Mobile, Alabama, United States

Loading trial locations.

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.
  • 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

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 who have uncontrolled clinically significant pre-existing electrolyte disturbances.
  • Subjects with severe liver or renal insufficiency.
  • Subjects with a history of congestive heart failure or other clinically significant cardiac abnormality.
  • Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
  • Subjects undergoing colonoscopy for foreign body removal and 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

PEG-3350 based bowel preparation

Drug

solution for oral administration prior to colonoscopy

BLI800 approved preparation regimen

Drug

solution for oral administration prior to colonoscopy

BLI800 investigational preparation regimen

Drug

solution for oral administration prior to colonoscopy

Primary outcomes

  1. Percentage 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).

Secondary outcomes

  1. Count and Percentage of Subjects With Adverse Events Through Day of Colonoscopy

    Time frame: 2 days

    Count and Percentage of subjects with AEs through Day of Colonoscopy based on 3% threshold. Outcome measure time frame represents the day prior to colonoscopy (when preparation Dose 1 is taken) and the day of colonoscopy (when preparation Dose 2 is taken).

  2. Count and Percentage of Subjects With Adverse Events After Colonoscopy Through Follow-up Day 7

    Time frame: 7 days

    Count and Percentage of subjects with AEs reported after colonoscopy through follow-up Day 7 based on 3% threshold. Outcome measure time frame represents the period following colonoscopy through follow-up Day 7 (7 days).

Sponsors and collaborators

Lead sponsor

Braintree Laboratories

Industry

Registry information

Official study title

A Safety, Tolerance and Efficacy Evaluation of 3 Different Bowel Cleansing Preparations in Adult Subjects, Including the Elderly and Subjects With Hepatic or Renal Insufficiency

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 29, 2011
Registry last updated
Jan 17, 2024

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.

Published trials that share one or more normalized conditions with this study.