A Safety Study of 3 Different Bowel Cleansing Preparations

Completed · Phase 3

Conditions studied: Colonoscopy, Bowel Preparation, Endoscopy

In brief

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.

Key facts

Study ID

NCT01501513

Run by

Braintree Laboratories

People needed

541

Starts

2011-12-01

Expected to finish

2013-03-04

Last updated by the study team

2024-01-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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