Status:
COMPLETED
BLI850-302: BLI850 vs an Approved Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy
Lead Sponsor:
Braintree Laboratories
Conditions:
Colon Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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, intra-uterine device, 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
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
386 Patients enrolled
Trial Details
Trial ID
NCT00756548
Start Date
August 1 2008
Last Update
December 27 2013
Active Locations (12)
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1
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
2
Advanced Clinical Research Institute
Orange, California, United States, 92869
3
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
4
Gastrointestinal Associates
Jackson, Mississippi, United States, 39202