Study 302: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy

Completed · Phase 3

Conditions studied: Colonoscopy

In brief

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.

Key facts

Study ID

NCT04446312

Run by

Braintree Laboratories

People needed

500

Starts

2020-07-13

Expected to finish

2021-02-05

Last updated by the study team

2023-10-27

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 302 Research Site 2 — Tucson, Arizona, United States
• 302 Research Site 10 — Little Rock, Arkansas, United States
• 302 Research Site 11 — North 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 22 — Bristol, Connecticut, 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 28 — Miami, Florida, United States
• 302 Research Site 29 — Miami, Florida, United States
• 302 Research Site 30 — Miami, Florida, United States
• 302 Research Site 38 — Palm Harbor, Florida, United States
• 302 Research Site 5 — Oak Lawn, Illinois, United States
• 302 Research Site 34 — Baton Rouge, Louisiana, United States
• 302 Research Site 26 — Mandeville, Louisiana, United States
• 302 Research Site 36 — Monroe, Louisiana, United States
• 302 Research Site 16 — Hagerstown, Maryland, United States
• 302 Research Site 39 — Brooklyn, New York, United States
• 302 Research Site 37 — Great Neck, New York, United States
• 302 Research Site 8 — Asheville, North Carolina, United States
• 302 Research Site 25 — High Point, North Carolina, United States
• 302 Research Site 1 — Raleigh, North Carolina, United States
• 302 Research Site 13 — Wilmington, North Carolina, United States
• 302 Research Site 18 — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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