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

Completed · Phase 3

Conditions studied: Colon Cancer

In brief

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

Key facts

Study ID

NCT00756977

Run by

Braintree Laboratories

People needed

394

Starts

2008-08-01

Last updated by the study team

2013-08-15

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 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
• 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 or decompression.
• Subjects with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.
• Subjects who had previous significant gastrointestinal surgeries (e.g. colostomy, colectomy, gastric bypass).
• 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 surgical, drug, or device study within the past 30 days.

Where it is running

• 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

Full record on ClinicalTrials.gov

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