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

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2013
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).
Epistemonikos ID: 78112bf46cea291d49e06b56bf11f5b745ec4155
First added on: May 11, 2024