Study 301: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy
Condition: Colonoscopy
Intervention: Bowel Prep
Intervention description: Orally ingested liquid bowel preparation
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 519.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

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 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.