A Study of the Efficacy and Safety of Bowklean and Klean-Prep With Dulcolax for the Bowel Preparation Prior Colonoscopy

Overview

The primary objective of this study is to demonstrate that investigation medication (Bowklean) is not less effective than the active comparator (Klean-Prep with Dulcolax), with regards to the overall quality of bowel preparation in subjects undergoing colonoscopy. An additional objective of this study is to collect subject's response to the acceptability and tolerability about bowel preparation and safety information. After bowel preparation, independent evaluator who is blinded to subject's treatment will evaluate the overall colon cleansing based on Aronchick and Ottawa scale. A total of 600 eligible subjects scheduled to a colonoscopy will be randomly assigned with equal allocation to 1 of 2 treatment groups: "Bowklean" or "Klean-Prep" with Dulcolax. Each subject's participation is expected to be maximally 4 weeks in study duration (up to 3-week screening period followed by one week post colonoscopy).

The objective of this study was to demonstrate that investigational medication (Bowklean) is not less effective than the active comparator (Klean-Prep with Dulcolax), with regards to the overall quality of bowel preparation in subjects undergoing colonoscopy. It was designed to measure the number of subjects whose colons are cleansed successfully. The primary efficacy endpoint is the percentage of subjects that achieve excellent or good cleansing (success rate) in the Aronchick Scale. The secondary efficacy variables include: 1. Proportion of successes (excellent, good, or fair) by individual colon segment (ascending, transverse, descending), which are assessed with the Ottawa scale6. 2. Mean bowel preparation score assessed with Ottawa Scale by adding points for the cleansing of three parts of colon and points for amount of fluid in the bowel. 3. Percentage of subject's responses to the acceptability and tolerability Safety was assessed at each clinic visit by evaluation of the following variables: 1. Percentage of subjects occurred solicited event (nausea, vomiting, chest pain and dizziness) during the preparation. 2. Percentage of subjects with treatment-emergent adverse events during the study period.