A Safety Study of 3 Different Bowel Cleansing Preparations

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

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.

Study Overview

• Status: Completed
• Conditions: Endoscopy; Colonoscopy; Bowel Preparation
• Intervention / Treatment: Drug: BLI800 approved preparation regimen; Drug: BLI800 investigational preparation regimen; Drug: PEG-3350 based bowel preparation

• Study Type: Interventional
• Enrollment (Actual): 541
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36693
      • University of South Alabama
  • California
    • Anaheim, California, United States, 92801
      • Advanced Clinical Research Institute
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Jacksonville
    • Jacksonville, Florida, United States, 32256
      • Borland-Groover Clinic
    • South Miami, Florida, United States, 33143
      • Miami Research Associates
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Louisiana
    • Monroe, Louisiana, United States, 71201
      • Delta Research Partners
  • Massachusetts
    • Brockton, Massachusetts, United States, 02302
      • Commonwealth Clinical Studies
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • Gastrointestinal Associates
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Asheville Gastroenterology Associates
    • Charlotte, North Carolina, United States, 28262
      • Carolina Digestive Health Associates
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Consultants for Clinical Research
  • Oregon
    • Portland, Oregon, United States, 97210
      • Northwest Gastroenterology
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • ClinSearch
    • Franklin, Tennessee, United States, 37067
      • Franklin Gastroenterology
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • Charlottesville Medical Research

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BLI800 approved preparation regimen	Drug: BLI800 approved preparation regimen; solution for oral administration prior to colonoscopy
Experimental: BLI800 investigational preparation regimen	Drug: BLI800 investigational preparation regimen; solution for oral administration prior to colonoscopy
Active Comparator: PEG-3350 based bowel preparation	Drug: PEG-3350 based bowel preparation; solution for oral administration prior to colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With Successful Bowel Preparation	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).	Day of colonoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Count and Percentage of Subjects With Adverse Events Through Day of Colonoscopy	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 days
Count and Percentage of Subjects With Adverse Events After Colonoscopy Through Follow-up Day 7	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).	7 days

Collaborators and Investigators

• Sponsor: Braintree Laboratories

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): March 4, 2013
• Study Completion (Actual): March 4, 2013

Study Registration Dates

• First Submitted: December 22, 2011
• First Submitted That Met QC Criteria: December 27, 2011
• First Posted (Estimated): December 29, 2011

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: colonoscopy; endoscopy; bowel preparation
• Additional Relevant MeSH Terms: Gastrointestinal Agents; Laxatives; Polyethylene glycol 3350
• Other Study ID Numbers: BLI800-440