BLI-800-301: BLI-800 vs an Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy

NCT ID: NCT00503607

Last Updated: 2007-12-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2007-11-30

Brief Summary

This is a randomized, parallel, multi-center, single-blind study, comparing BLI-800 to an FDA approved bowel preparation in adult subjects undergoing colonoscopy.

Conditions

Colonoscopy

Keywords

colonoscopy; bowel preparation; prep

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Interventions

BLI-800

Intervention Type: DRUG

Polyethylene glycol 3350 based bowel preparation

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication, including:

• Evaluation of BE results
• GI bleeding
• Anemia of unknown etiology
• Neoplastic disease surveillance
• Endosonography
• Inflammatory bowel disease
• Unknown diarrhea or constipation etiology
• Polypectomy
• Laser therapy
• Routine Screening
• At least 18 years of age
• Otherwise in good health, as determined by physical exam and medical history
• 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)
• Negative urine pregnancy test at screening, if applicable
• In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Exclusion Criteria

• Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or megacolon.
• Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
• Subjects who are undergoing colonoscopy for foreign body removal and decompression.
• Subjects with clinically significant electrolyte abnormalities based on Visit 1 laboratory results, such as hypernatremia, hyponatremia, hyperphosphatemia, hypokalemia, hypocalcemia, dehydration, or those secondary to the use of diuretics or angiotensin converting enzyme (ACE) inhibitors.
• Subjects with a history of renal or hepatic insufficiency or congestive heart failure.
• Subjects who had previous gastrointestinal surgeries
• Subjects who are pregnant or lactating, or intending to become pregnant during the study.
• Subjects of childbearing potential who refuse a pregnancy test.
• Subjects who are allergic to any preparation components
• Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
• Subjects who have participated in an investigational clinical, 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

Braintree Laboratories, Inc.

Principal Investigators

John D McGowan, BS

Role: STUDY_DIRECTOR

Braintree Laboratories, Inc.

Locations

Mobile, Alabama, United States

Washington D.C., District of Columbia, United States

Jupiter, Florida, United States

Miami, Florida, United States

New Smyrna Beach, Florida, United States

Monroe, Louisiana, United States

Laurel, Maryland, United States

Great Neck, New York, United States

Raleigh, North Carolina, United States

Lancaster, Pennsylvania, United States

Chesapeake, Virginia, United States

Countries

United States

Other Identifiers

BLI-800-301

Identifier Type: -

Identifier Source: org_study_id