A Safety and Efficacy Comparison of BLI4900 Bowel Preparation Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy

BLI4900-302

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.

2020-07-13

2021-01-07

2021-02-05

Completed

Early phase I

500

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 uncontrolled hypertension. * Subjects taking antibiotics within 7 days of colonoscopy. * Subjects with severe renal, hepatic or cardiac insufficiency. * Subjects with an abnormal and clinically significant physical examination or ECG finding at Visit 1. * Subjects undergoing insulin therapy for any indication. * Subjects with impaired consciousness that predisposes them to pulmonary aspiration. * Subjects undergoing colonoscopy for foreign body removal and/or decompression. * Subjects taking tricyclic antidepressants. * Subjects using drugs of abuse, including abused prescription medications. * Subjects who are withdrawing from alcohol or benzodiazepines.

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2023-10-27