Study 301: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy

Study Overview
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Brief Summary
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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.

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

Conditions
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Colonoscopy

Intervention / Treatment
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* Drug: Bowel Prep


Participation Criteria
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Eligibility Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BLI4900<br>Experimental bowel preparation solution for oral ingestion | Drug: Bowel Prep<br>* Orally ingested liquid bowel preparation<br>|
| Active Comparator: FDA Approved Control<br>FDA approved bowel preparation solution for oral ingestion | Drug: Bowel Prep<br>* Orally ingested liquid bowel preparation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion 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). | 2 days |