A Safety and Efficacy Evaluation of 3 Bowel Preparations in the Pediatric Population
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.
Drug: HalfLytely and Bisacodyl Tablets - Formulation 1
Drug: HalfLytely and Bisacodyl Tablets - Formulation 2
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Official Title:||A Safety and Efficacy Evaluation of 3 Bowel Preparations in the Pediatric Population|
- Efficacy - preparation quality using a 4-point scale
- Safety - patient reported preparation related side effects. Pre and post preparation analysis of serum chemistry.
|Study Start Date:||January 2007|
|Study Completion Date:||May 2007|
|Primary Completion Date:||May 2007 (Final data collection date for primary outcome measure)|
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|Study Director:||John McGowan||Braintree Laboratories, Inc.|