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Sponsored by: |
Braintree Laboratories |
Information provided by: | Braintree Laboratories |
ClinicalTrials.gov Identifier: | NCT00425594 |
This randomized, parallel, multi-center, single-blind study is designed to compare the safety and efficacy of 3 bowel preparations in pediatric subjects scheduled to undergo a colonoscopy for a routinely accepted indication.
Condition | Intervention | Phase |
Colonoscopy |
Drug: HalfLytely and Bisacodyl Tablets - Formulation 1 Drug: HalfLytely and Bisacodyl Tablets - Formulation 2 Drug: NuLYTELY |
Phase IV |
ChemIDplus related topics: | Nulytely Bisacodyl Bisacodyl tannex |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Active Control, Parallel Assignment |
Official Title: | A Safety and Efficacy Evaluation of 3 Bowel Preparations in the Pediatric Population |
Estimated Enrollment: | 150 |
Study Start Date: | January 2007 |
Study Completion Date: | May 2007 |
Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 6 Years to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Male or female patients who are undergoing colonoscopy for a routinely accepted indication, including:
Exclusion Criteria:
Show 26 Study Locations |
Braintree Laboratories |
Study Director: | John McGowan | Braintree Laboratories, Inc. |
Responsible Party: | Braintree Laboratories, Inc. ( John McGowan, Clinical Operations Manager ) |
Study ID Numbers: | F38-25 |
First Received: | January 19, 2007 |
Last Updated: | December 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00425594 |
Health Authority: | United States: Food and Drug Administration |
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