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

Completed · Phase 3

Conditions studied: Colonoscopy

In brief

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

Key facts

Study ID

NCT00503607

Run by

Braintree Laboratories

People needed

400

Starts

2007-07-01

Expected to finish

2007-11-01

Last updated by the study team

2007-12-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Study site — Mobile, Alabama, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Jupiter, Florida, United States
• Study site — Miami, Florida, United States
• Study site — New Smyrna Beach, Florida, United States
• Study site — Monroe, Louisiana, United States
• Study site — Laurel, Maryland, United States
• Study site — Great Neck, New York, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Lancaster, Pennsylvania, United States
• Study site — Chesapeake, Virginia, United States

Full record on ClinicalTrials.gov

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