BLI850-302: BLI850 vs an Approved Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy

NCT ID: NCT00756548

Last Updated: 2013-12-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 386 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31

Brief Summary

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

Conditions

Colon Cancer

Keywords

colonoscopy; screening

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

multi-dose preparation for oral administration prior to colonoscopy

Group Type: EXPERIMENTAL

BLI850

Intervention Type: DRUG

multi-dose preparation for oral administration prior to colonoscopy

2

multi-dose preparation for oral administration prior to colonoscopy

Group Type: ACTIVE_COMPARATOR

polyethylene glycol 3350 based bowel preparation

Intervention Type: DRUG

multi-dose preparation for oral administration prior to colonoscopy

Interventions

BLI850

multi-dose preparation for oral administration prior to colonoscopy

Intervention Type: DRUG

polyethylene glycol 3350 based bowel preparation

multi-dose preparation for oral administration prior to colonoscopy

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Braintree Laboratories

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Advanced Clinical Research Institute

Anaheim, California, United States

Advanced Clinical Research Institute

Orange, California, United States

Indiana University Medical Center

Indianapolis, Indiana, United States

Gastrointestinal Associates

Jackson, Mississippi, United States

Options Health Research

Tulsa, Oklahoma, United States

Northwest Gastroenterology Clinic

Portland, Oregon, United States

Franklin Gastroenterology

Franklin, Tennessee, United States

Memphis Gastroenterology Group

Germantown, Tennessee, United States

The Frist Clinic

Nashville, Tennessee, United States

Houston Medical Research Associates

Houston, Texas, United States

Charlottesville Medical Research

Charlottesville, Virginia, United States

Northwest Gastroenterology Associates

Bellevue, Washington, United States

Countries

United States

Other Identifiers

BLI850-302

Identifier Type: -

Identifier Source: secondary_id

BLI850-302

Identifier Type: -

Identifier Source: org_study_id