Kristalose as Bowel Evacuant Prior to Colonoscopy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01256541|
Recruitment Status : Completed
First Posted : December 8, 2010
Last Update Posted : October 6, 2011
|Condition or disease||Intervention/treatment||Phase|
|Bowel Evacuant Prior to Colonoscopy||Drug: Kristalose||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Center, Open-Label, Pilot Study to Determine the Safety, Efficacy, and Patient Preference of Kristalose as a Bowel Evacuant Prior to Colonoscopy|
|Study Start Date :||December 2010|
|Primary Completion Date :||September 2011|
|Study Completion Date :||September 2011|
Kristalose as Bowel Evacuant
The dosing regimen of Kristalose will be nine 20-gram doses (one dose every 30 minutes for 4 straight hours) taken the evening before the colonoscopy procedure.
- Hydrogen and Methane Gas Production [ Time Frame: 3 months ]
To evaluate the primary objective of hydrogen and methane gas production as measured by:
• Pre- and post-dose breath analysis for hydrogen and methane gas.
- Efficacy [ Time Frame: 3 months ]
To evaluate the secondary objective of efficacy, the following endpoints will be measured:
- Physician's determination of the cleanliness of the colon will be evaluated by completion of the Boston bowel prep scale.
- The number and percentage of patient's who by the physician's determination are considered treatment failures (patients with insufficient evacuation of the bowel=Boston bowel prep score < 5, and/or any colon segment score of 0).
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): NCT01256541
|United States, Washington|
|Virginia Mason Medical Center|
|Seattle, Washington, United States, 98101|