BLI850 vs an Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Braintree Laboratories
• Treatments: Polyethylene glycol 3350

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, IUD, 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.