Evaluation of Proposed EZ2go Complete Bowel Cleansing System
This study aims to provide safety and efficacy data comparable to available over-the-counter bowel preparations prior to colonoscopy. While there are many bowel preparations available, most of them remain expensive and require prescription from a health provider. The investigators believe EZ2go Complete will provide a non-inferior colon cleansing in a more accessible way (over-the-counter).
To accomplish this goal, the investigators decided to evaluate the proposed EZ2go combination versus currently available over-the-counter bowel preparations. The investigators believe the EZ2go kit will not be inferior to current FDA approved over-the-counter bowel preparations.
|Screening Colonoscopy Surveillance Colonoscopy Colonoscopy||Other: Ez2go Complete Other: LoSo Prep|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
|Official Title:||Randomized, Single Blinded Study of Proposed EZ2go Complete Bowel Cleansing System: Evaluation of Its Safety, Efficacy and Patient Tolerance Compared to LOSO Prep, an Over the Counter Laxative Kit for Colonoscopy Bowel Preparation|
- Measurement of Efficacy [ Time Frame: 24 hours ]The primary end point is efficacy of colonoscopy preparation measured by the Ottawa scale.
- Evaluate the safety [ Time Frame: 2 weeks ]A basic metabolic panel will be drawn at baseline and after the bowel preparation is complete to evaluate for any electrolyte and renal disturbances.
|Study Start Date:||April 2013|
|Study Completion Date:||June 2014|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Experimental: EZ2go Complete
EZ2go complete: Peg 3350, Magnesium Citrate and Simethicone
Other: Ez2go Complete
Active Comparator: LoSo Prep ™
LoSo Prep ™: Magnesium citrate and Bisacodyl
Other: LoSo Prep
LoSo Prep ™ Magnesium Citrate plus Bisacodyl Kit Study Arm
Please refer to this study by its ClinicalTrials.gov identifier: NCT01838408
|United States, Florida|
|Jacksonville, Florida, United States, 32256|