Colon Cancer Clinical Trial

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

Summary

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

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

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 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.

Study is for people with:

Colon Cancer

Phase:

Phase 3

Estimated Enrollment:

394

Study ID:

NCT00756977

Recruitment Status:

Completed

Sponsor:

Braintree Laboratories

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There are 12 Locations for this study

See Locations Near You

University of South Alabama
Mobile Alabama, 36693, United States
Jupiter Research
Jupiter Florida, 33458, United States
Miami Research Associates
Miami Florida, 33143, United States
United Medical Research
New Smyrna Beach Florida, 32168, United States
Atlanta Gastroenterology Associates
Roswell Georgia, 30076, United States
Delta Research Partners
Monroe Louisiana, 71201, United States
Maryland Digestive Disease Research
Laurel Maryland, 20707, United States
Long Island GI Research Group
Great Neck New York, 11023, United States
Carolina Digestive Health Associates
Harrisburg North Carolina, 28075, United States
Wake Research Associates
Raleigh North Carolina, 27612, United States
Regional Gastroenterology Associates of Lancaster
Lancaster Pennsylvania, 17604, United States
Southeastern Clinical Research
Chattanooga Tennessee, 37403, United States

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 3

Estimated Enrollment:

394

Study ID:

NCT00756977

Recruitment Status:

Completed

Sponsor:


Braintree Laboratories

How clear is this clinincal trial information?

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