BLI850-302: BLI850 vs an Approved Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy
Condition: Colon Cancer
MeSH terms: Colonic Neoplasms
Intervention: BLI850; polyethylene glycol 3350 based bowel preparation
Intervention description: multi-dose preparation for oral administration prior to colonoscopy; multi-dose preparation for oral administration prior to colonoscopy
Intervention MeSH terms: Polyethylene glycol 3350
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 386.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: colonoscopy; screening

Summary:

      This is a randomized, parallel, multi-center, single-blind study, comparing BLI850 to an FDA
      approved bowel preparation in adult subjects undergoing colonoscopy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female outpatients who are undergoing colonoscopy for a routinely accepted
             indication, including:

               -  Evaluation of barium enema results

               -  GI bleeding

               -  Anemia of unknown etiology

               -  Neoplastic disease surveillance

               -  Abnormal Endosonography

               -  Inflammatory bowel disease

               -  Unknown diarrhea or constipation etiology

               -  Polypectomy

               -  Laser therapy

               -  Routine screening

          2. At least 18 years of age.

          3. Otherwise in good health, as determined by physical exam and medical history.

          4. If female, and of child-bearing potential, is using an acceptable form of birth
             control (hormonal birth control, intra-uterine device, double-barrier method, depot
             contraceptive, abstinent, or vasectomized spouse).

          5. Negative urine pregnancy test at screening, if applicable.

          6. In the Investigator's judgment, subject is mentally competent to provide informed
             consent to participate in the study.

        Exclusion Criteria:

          1. Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal
             obstruction, gastric retention, bowel perforation, toxic colitis, or megacolon.

          2. Subjects with impaired consciousness that predisposes them to pulmonary aspiration.

          3. Subjects who are undergoing colonoscopy for foreign body removal or decompression.

          4. Subjects with clinically significant electrolyte abnormalities based on Visit 1
             laboratory results.

          5. Subjects who had previous significant gastrointestinal surgeries (e.g. colostomy,
             colectomy, gastric bypass).

          6. Subjects who are pregnant or lactating, or intending to become pregnant during the
             study.

          7. Subjects of childbearing potential who refuse a pregnancy test.

          8. Subjects who are allergic to any preparation components

          9. Subjects who, in the opinion of the Investigator, should not be included in the study
             for any reason, including inability to follow study procedures.

         10. Subjects who have participated in an investigational surgical, drug, or device study
             within the past 30 days.