Evaluation of Proposed EZ2go Complete Bowel Cleansing System
|ClinicalTrials.gov Identifier: NCT01838408|
Recruitment Status : Completed
First Posted : April 24, 2013
Last Update Posted : January 27, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Screening Colonoscopy Surveillance Colonoscopy Colonoscopy||Other: Ez2go Complete Other: LoSo Prep||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||185 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||June 2014|
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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01838408
|United States, Florida|
|Jacksonville, Florida, United States, 32256|