Colon Disease Clinical Trial
Official title:
A Prospective, Randomized, Single-blinded (Evaluator), 3-treatment Arm, Parallel, Multi-center, Phase 3 Trial to Evaluate Safety and Efficacy of CDFR0612 and CDFR0613
The purpose of this study is to evaluate the safety and efficacy of CDFR0612 and CDFR0613 compared to PEG+picosulfate (Coolprep Powder) preparation. The effectiveness for bowel cleansing will be assessed with Harefield Cleansing Scale (HCS) by blinded assessor.
This study is a prospective, randomized, single-blinded, parallel, 3-treatment, multi-center clinical trial. A total of 297 subjects scheduled for colonoscopy will participate to this study and be assigned to 3 groups - CDFR0612, CDFR0613, or a comparator (Coolprep Powder). A subject will admit to hospital one day before colonoscopy and be administrated with study drug. In early morning at the that day of colonoscopy, he/she will be administrated with study drug again. Any subject will be carefully monitored for safety during hospitalisation (1 night) and additional 4 weeks follow-up period because this study is the first human trial of CDFR0612 and CDFR0613. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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