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

Braintree Laboratories

Status and phase: Completed; Phase 3

Conditions: Colon Cancer

Treatments: Drug: polyethylene glycol 3350 based bowel preparation; Drug: BLI850

Study type: Interventional

Funder types: Industry

Identifiers

NCT00756977

BLI850-301

Details and patient eligibility

About

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

Enrollment: 394 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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394 participants in 2 patient groups

1

Experimental group

Description:

multi-dose preparation for oral administration prior to colonoscopy

Treatment:

Drug: BLI850

2

Active Comparator group

Description:

multi-dose preparation for oral administration prior to colonoscopy

Treatment:

Drug: polyethylene glycol 3350 based bowel preparation