A Safety and Efficacy Comparison of BLI4700 Bowel Prep Versus an FDA-approved Comparator in Adults Prior to Colonoscopy
Condition: Colonoscopy
Intervention: BLI4700; Polyethylene glycol bowel preparation
Intervention description: Oral bowel preparation; Oral bowel preparation
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 620.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The objective of this study is to compare the safety and efficacy of BLI4700 bowel
      preparation to an FDA-approved bowel preparation 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 ongoing severe, acute inflammatory bowel disease

          -  Subjects who had previous significant gastrointestinal surgeries.

          -  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. NSAID use for occasional pain
             is not exclusionary.

          -  Subjects with uncontrolled hypertension (systolic blood pressure > 170 mmHg or
             diastolic blood pressure > 100 mmHg).

          -  Subjects taking antibiotics within 7 days of colonoscopy.

          -  Subjects with severe renal insufficiency (GFR < 30 mL/min/1.73m2).

          -  Subjects with known severe hepatic insufficiency (Child Pugh C)

          -  Subjects with cardiac insufficiency (NYHA Functional Classifications 3 or 4).

          -  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 who are pregnant or lactating, or intending to become pregnant during the
             study.

          -  Subjects of childbearing potential who refuse a pregnancy test.

          -  Subjects allergic to any preparation component.

          -  Subjects using drugs of abuse, including abused prescription medications.

          -  Subjects who are withdrawing from alcohol or benzodiazepines.

          -  Subjects who, in the opinion of the Investigator, should not be included in the study
             for any reason, including inability to follow study procedures.

          -  Subjects who have participated in an investigational surgical, drug, or device study
             within the past 30 days.