Study 302: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy
- Conditions
- Colonoscopy
- Interventions
- Drug: Bowel Prep
- Registration Number
- NCT04446312
- Lead Sponsor
- Braintree Laboratories
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BLI4900 Bowel Prep Experimental bowel preparation solution for oral ingestion FDA Approved Control Bowel Prep FDA approved bowel preparation solution for oral ingestion
- Primary Outcome Measures
Name Time Method Proportion of Subjects With Successful Bowel Preparation 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 Outcome Measures
Name Time Method
Trial Locations
- Locations (34)
302 Research Site 5
🇺🇸Oak Lawn, Illinois, United States
302 Research Site 39
🇺🇸Brooklyn, New York, United States
302 Research Site 28
🇺🇸Miami, Florida, United States
302 Research Site 29
🇺🇸Miami, Florida, United States
302 Research Site 30
🇺🇸Miami, Florida, United States
302 Research Site 21
🇺🇸Houston, Texas, United States
302 Research Site 33
🇺🇸Kingsport, Tennessee, United States
302 Research Site 26
🇺🇸Mandeville, Louisiana, United States
302 Research Site 36
🇺🇸Monroe, Louisiana, United States
302 Research Site 34
🇺🇸Baton Rouge, Louisiana, United States
302 Research Site 11
🇺🇸North Little Rock, Arkansas, United States
302 Research Site 22
🇺🇸Bristol, Connecticut, United States
302 Research Site 2
🇺🇸Tucson, Arizona, United States
302 Research Site 23
🇺🇸Jackson, Tennessee, United States
302 Research Site 10
🇺🇸Little Rock, Arkansas, United States
302 Research Site 9
🇺🇸Chula Vista, California, United States
302 Research Site 31
🇺🇸Los Angeles, California, United States
302 Research Site 17
🇺🇸Fleming Island, Florida, United States
302 Research Site 3
🇺🇸Inverness, Florida, United States
302 Research Site 14
🇺🇸Jacksonville, Florida, United States
302 Research Site 38
🇺🇸Palm Harbor, Florida, United States
302 Research Site 16
🇺🇸Hagerstown, Maryland, United States
302 Research Site 37
🇺🇸Great Neck, New York, United States
302 Research Site 25
🇺🇸High Point, North Carolina, United States
302 Research Site 8
🇺🇸Asheville, North Carolina, United States
302 Research Site 1
🇺🇸Raleigh, North Carolina, United States
302 Research Site 18
🇺🇸Cincinnati, Ohio, United States
302 Research Site 13
🇺🇸Wilmington, North Carolina, United States
302 Research Site 32
🇺🇸Cedar Park, Texas, United States
302 Research Site 27
🇺🇸Webster, Texas, United States
302 Research Site 35
🇺🇸Southlake, Texas, United States
302 Research Site 7
🇺🇸Bellevue, Washington, United States
302 Research Site 4
🇺🇸Fairfax, Virginia, United States
302 Research Site 6
🇺🇸Charlottesville, Virginia, United States