Status:
COMPLETED
Study 302: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy
Lead Sponsor:
Braintree Laboratories
Conditions:
Colonoscopy
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 5 2021
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04446312
Start Date
July 13 2020
End Date
February 5 2021
Last Update
October 27 2023
Active Locations (34)
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1
302 Research Site 2
Tucson, Arizona, United States, 85712
2
302 Research Site 10
Little Rock, Arkansas, United States, 72211
3
302 Research Site 11
North Little Rock, Arkansas, United States, 72117
4
302 Research Site 9
Chula Vista, California, United States, 91910