Safety, Efficacy, and Patient Preference of Split-Dose Crystalline Lactulose as a Preparation for Colonoscopy in Adults
The purpose of this study is to determine the efficacy of a split-dose regimen of crystalline lactulose for cleansing of the colon as a preparation for colonoscopy, as assessed by the physician's determination of the cleanliness of the colon using the Boston Bowel Prep Scale (BBPS).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||A Single Center, Randomized, Single-blind Pilot Study to Determine the Safety, Efficacy, and Patient Preference of Split-Dose Regimen of Crystalline Lactulose for Cleansing of the Colon as a Preparation for Colonoscopy in Adults|
- Cleanliness of the Colon During Colonoscopy [ Time Frame: Day of the procedure ] [ Designated as safety issue: No ]
To evaluate the primary objective of efficacy of the split-dose, the following endpoint will be measured:
o Physician's determination of the cleanliness of the colon will be evaluated by completion of the Boston bowel prep scale.
- Treatment Failures [ Time Frame: Day of the procedure ] [ Designated as safety issue: No ]
To evaluate the secondary objective of efficacy, the following endpoint will be measured:
o 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).
- Patient Tolerability and Preference [ Time Frame: Day before and day of colonoscopy ] [ Designated as safety issue: No ]To evaluate the secondary objective of patient tolerability and preference on the basis of the following assessments: Patient tolerability and preference questionnaire including 100 mm Visual Analog Scale (VAS) and Likert Scale
- Colonic Hydrogen and Methane Gas Production [ Time Frame: Day of colonoscopy ] [ Designated as safety issue: No ]
To evaluate the secondary objective of measuring colonic hydrogen and methane gas production as measured by:
o Colonic hydrogen and methane gas levels.
- Safety/Adverse Events [ Time Frame: Day before colonoscopy till 7 days after colonoscopy ] [ Designated as safety issue: Yes ]To evaluate the secondary objective of safety as measured by the incidence of treatment emergent adverse events
|Study Start Date:||July 2012|
|Study Completion Date:||September 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Evening Only (full-dose)
The dosing regimen of Crystalline lactulose will be four 45-gram doses (one dose every 60 minutes for 4 straight hours) taken the evening before the colonoscopy procedure.
|Drug: Crystalline Lactulose|
The dosing regimen of Crystalline lactulose will be three 45-gram doses (one dose every 60 minutes for 3 straight hours) taken the evening before the colonoscopy procedure followed by one 45-gram dose the morning before the colonoscopy procedure.
|Drug: Crystalline Lactulose|
This is a single center, open-label, pilot study to determine the safety, efficacy, and patient preference of a split-dose regimen of Crystalline Lactulose for cleansing of the colon prior to colonoscopy. Safety will be assessed by the occurrence of any treatment emergent adverse events. Efficacy will be determined by the endoscopist's rating of the cleanliness of the colon and the incidence of treatment failure (insufficient evacuation of the bowel). Patient preference will be determined by the patient's responses on a patient questionnaire.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01650870
|United States, Washington|
|Virginia Mason Medical Center|
|Seattle, Washington, United States, 98101|
|Principal Investigator:||Otto Lin, MD||Virginia Mason Medical Center|