Study 301: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy (NCT04446299) | Clinical Trial Compass
CompletedPhase 3
Study 301: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy
United States519 participantsStarted 2020-07-13
Plain-language summary
The purpose of this study is to compare the safety and efficacy of BLI4900 bowel preparation to an FDA-approved control as 2-day, split-dose bowel preparations prior to colonoscopy in adult patients.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion Criteria:
* Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication.
* 18 to 85 years of age (inclusive)
* If female, and of child-bearing potential, is using an acceptable form of birth control.
* Negative serum 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, gastrointestinal obstruction, gastroparesis, gastric retention, bowel perforation, toxic colitis or megacolon.
* Subjects with inflammatory bowel disease who have a history of any bowel resection (small intestine or colon), suspected active inflammation, or symptoms suggestive of obstruction or known bowel stricture.
* Subjects who had previous significant gastrointestinal surgeries.
* Subjects who have regularly used laxatives or colon motility altering drugs in the last month (i.e. more than 2-3 times per week) and/or laxative use within 72 hours prior to administration of the preparation
* Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.
* Subjects taking diuretics, anti-hypertensive medications, including angiotensin converting enzyme (ACE) inhibitors and Angiotensin II receptor blockers (ARBs), or chronic NSAIDs, that have not been stable for 30 days.
* Subjects with uncontro…
What they're measuring
1
Proportion of Subjects With Successful Bowel Preparation