Clinical Evaluation of a New Reduced Volume Bowel Preparation
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|ClinicalTrials.gov Identifier: NCT00321230|
Recruitment Status : Completed
First Posted : May 3, 2006
Last Update Posted : April 16, 2008
|Condition or disease||Intervention/treatment||Phase|
|Colonoscopy||Drug: macrogol3350 NA sulphate NACL KCL ascorbic acid NA ascorbate||Phase 2|
Open prospective pilot monocentric phase II clinical trial evaluating the therapeutic efficacy of a new "Low Dose Bowel Prep" formulation for gut cleansing prior to colonoscopy.
Thirty patients admitted to the hospital (inpatients) planned to undergo a complete colonoscopy will have gut cleansing with the "Low Dose Bowel Prep" using a one-step intake mode.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Monocentric, Open Phase II Study to Investigate the Efficacy and Safety of a New Oral Gut Cleansing Solution ("Low Dose Bowel Prep") in 30 Patients Submitted to Colonoscopy|
|Study Start Date :||January 2001|
|Estimated Study Completion Date :||May 2001|
- Efficacy measured by a final scoring system i.e., "the overall quality of colonoscopy prep" that will be graded (from A to C) and assessed from the degree of cleansing in a 0 - 4 grade scale for each of the predefined colon areas.
- Stool weight as recorded on the case report form for each stool as from start of gut cleansing (day -1) to the beginning of colonoscopy (day 0).
- Amount of fluid removed from the colon during the colonoscopy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00321230
|Hôpital Lariboisière, Endoscopy Department|
|Paris, France, 75010|
|Principal Investigator:||Alain Bitoun, MD||Hôpital Lariboisière|