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

NCT ID: NCT00756977

Last Updated: 2013-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 394 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, 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.

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

Sponsors

Braintree Laboratories

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John D McGowan

Role: STUDY_DIRECTOR

Braintree Laboratories

Locations

University of South Alabama

Mobile, Alabama, United States

Jupiter Research

Jupiter, Florida, United States

Miami Research Associates

Miami, Florida, United States

United Medical Research

New Smyrna Beach, Florida, United States

Atlanta Gastroenterology Associates

Roswell, Georgia, United States

Delta Research Partners

Monroe, Louisiana, United States

Maryland Digestive Disease Research

Laurel, Maryland, United States

Long Island GI Research Group

Great Neck, New York, United States

Carolina Digestive Health Associates

Harrisburg, North Carolina, United States

Wake Research Associates

Raleigh, North Carolina, United States

Regional Gastroenterology Associates of Lancaster

Lancaster, Pennsylvania, United States

Southeastern Clinical Research

Chattanooga, Tennessee, United States

Countries

United States

Other Identifiers

BLI850-301

Identifier Type: -

Identifier Source: secondary_id

BLI850-301

Identifier Type: -

Identifier Source: org_study_id