NCT04446312CompletedPhase 3
A Safety and Efficacy Comparison of BLI4900 Bowel Preparation Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy
Braintree Laboratories34 sites in 1 country500 target enrollmentStarted: July 13, 2020Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 500
- Locations
- 34
- Primary Endpoint
- Proportion of Subjects With Successful Bowel Preparation
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
BLI4900
Experimental
Experimental bowel preparation solution for oral ingestion
Intervention: Bowel Prep (Drug)
FDA Approved Control
Active Comparator
FDA approved bowel preparation solution for oral ingestion
Intervention: Bowel Prep (Drug)
Outcomes
Primary Outcomes
Proportion of Subjects With Successful Bowel Preparation
Time Frame: 2 days
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 Outcomes
No secondary outcomes reported
Investigators
Study Sites (34)
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