Study 301: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy
- Conditions
- Colonoscopy
- Interventions
- Drug: Bowel Prep
- Registration Number
- NCT04446299
- 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
- 519
- 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 FDA Approved Control Bowel Prep FDA approved bowel preparation solution for oral ingestion BLI4900 Bowel Prep Experimental 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 (25)
301 Research Site 18
🇺🇸Huntsville, Alabama, United States
301 Research Site 24
🇺🇸Sun City, Arizona, United States
301 Research Site 12
🇺🇸Jacksonville, Florida, United States
301 Research Site 21
🇺🇸Mentor, Ohio, United States
301 Research Site 23
🇺🇸New York, New York, United States
301 Research Site 20
🇺🇸Hixson, Tennessee, United States
301 Research Site 22
🇺🇸Milwaukee, Wisconsin, United States
301 Research Site 7
🇺🇸San Diego, California, United States
301 Research Site 16
🇺🇸Clearwater, Florida, United States
301 Research Site 9
🇺🇸Palm Harbor, Florida, United States
301 Research Site 25
🇺🇸Sunrise, Florida, United States
301 Research Site 14
🇺🇸Saint Petersburg, Florida, United States
301 Research Site 4
🇺🇸Palmetto Bay, Florida, United States
301 Research Site 2
🇺🇸Decatur, Georgia, United States
301 Research Site 10
🇺🇸Indianapolis, Indiana, United States
301 Research Site 17
🇺🇸Shreveport, Louisiana, United States
301 Research Site 3
🇺🇸Monroe, Louisiana, United States
301 Research Site 13
🇺🇸Chesterfield, Missouri, United States
301 Research Site 11
🇺🇸Flowood, Mississippi, United States
301 Research Site 19
🇺🇸Reno, Nevada, United States
301 Research Site 5
🇺🇸Great Neck, New York, United States
301 Research Site 15
🇺🇸Brooklyn, New York, United States
301 Research Site 1
🇺🇸Ogden, Utah, United States
301 Research Site 6
🇺🇸Raleigh, North Carolina, United States
301 Research Site 26
🇺🇸Port Orange, Florida, United States