A Safety Study of 3 Different Bowel Cleansing Preparations

Phase 3

Completed

Interventions: Drug: BLI800 approved preparation regimen
Drug: PEG-3350 based bowel preparation
Drug: BLI800 investigational preparation regimen

Brief Summary: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
BLI800 approved preparation regimen	BLI800 approved preparation regimen	BLI800 approved preparation regimen
PEG-3350 based bowel preparation	PEG-3350 based bowel preparation	PEG-3350 based bowel preparation
BLI800 investigational preparation regimen	BLI800 investigational preparation regimen	BLI800 investigational preparation regimen

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Successful Bowel Preparation	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 Outcome Measures

Name	Time	Method
Count and Percentage of Subjects With Adverse Events Through Day of Colonoscopy	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).
Count and Percentage of Subjects With Adverse Events After Colonoscopy Through Follow-up Day 7	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).

Locations (17): Mayo Clinic Jacksonville
🇺🇸
Jacksonville, Florida, United States
Advanced Clinical Research Institute
🇺🇸
Anaheim, California, United States
Borland-Groover Clinic
🇺🇸
Jacksonville, Florida, United States
Asheville Gastroenterology Associates
🇺🇸
Asheville, North Carolina, United States
University of South Alabama
🇺🇸
Mobile, Alabama, United States
Commonwealth Clinical Studies
🇺🇸
Brockton, Massachusetts, United States
Delta Research Partners
🇺🇸
Monroe, Louisiana, United States
Indiana University
🇺🇸
Indianapolis, Indiana, United States
Consultants for Clinical Research
🇺🇸
Cincinnati, Ohio, United States
Wake Research Associates
🇺🇸
Raleigh, North Carolina, United States
Carolina Digestive Health Associates
🇺🇸
Charlotte, North Carolina, United States
Franklin Gastroenterology
🇺🇸
Franklin, Tennessee, United States
Charlottesville Medical Research
🇺🇸
Charlottesville, Virginia, United States
Miami Research Associates
🇺🇸
South Miami, Florida, United States
Gastrointestinal Associates
🇺🇸
Jackson, Mississippi, United States
ClinSearch
🇺🇸
Chattanooga, Tennessee, United States
Northwest Gastroenterology
🇺🇸
Portland, Oregon, United States