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Sponsored by: |
Braintree Laboratories |
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Information provided by: | Braintree Laboratories |
ClinicalTrials.gov Identifier: | NCT00856843 |
To evaluate the safety and efficacy of BLI800 vs an FDA approved bowel preparation before colonoscopic examination in adult subjects.
Condition | Intervention | Phase |
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Colonoscopy |
Drug: BLI800 Drug: Polyethylene glycol 3350 based bowel preparation |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | BLI800-303: An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects |
Estimated Enrollment: | 120 |
Study Start Date: | February 2009 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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2: Active Comparator
Polyethylene glycol 3350 based bowel preparation
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Drug: Polyethylene glycol 3350 based bowel preparation
Solution for oral administration prior to colonoscopy
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1: Experimental
BLI800
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Drug: BLI800
Solution for oral administration prior to colonoscopy
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
University of South Alabama | |
Mobile, Alabama, United States, 36693 | |
United States, Florida | |
Jupiter Research | |
Jupiter, Florida, United States, 33458 | |
Miami Research Associates | |
Miami, Florida, United States, 33143 | |
United States, Indiana | |
Indiana University Medical Center | |
Indianapolis, Indiana, United States, 46202 | |
United States, New York | |
Long Island GI Research Group | |
Great Neck, New York, United States, 11023 |
Study Director: | John McGowan, BS | Braintree Laboratories, Inc. |
Responsible Party: | Braintree Laboratories, Inc. ( John McGowan, Clinical Operations Mgr. ) |
Study ID Numbers: | BLI800-303 |
Study First Received: | March 5, 2009 |
Last Updated: | April 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00856843 History of Changes |
Health Authority: | United States: Food and Drug Administration |
colonoscopy bowel preparation |