Study 301: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy

Braintree Laboratories

Status and phase

Completed

Phase 3

Conditions

Colonoscopy

Treatments

Drug: Bowel Prep

Study type

Interventional

Funder types

Industry

Identifiers

NCT04446299

BLI4900-301

Details and patient eligibility

About

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.

Enrollment

519 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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 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.