Safety, Efficacy, and Patient Preference of Split-Dose Crystalline Lactulose as a Preparation for Colonoscopy in Adults
|ClinicalTrials.gov Identifier: NCT01650870|
Recruitment Status : Completed
First Posted : July 26, 2012
Last Update Posted : August 8, 2014
|Condition or disease||Intervention/treatment||Phase|
|Colonoscopy||Drug: Crystalline Lactulose||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2012|
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
- Cleanliness of the Colon During Colonoscopy [ Time Frame: Day of the procedure ]
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 ]
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 ]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 ]
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 ]To evaluate the secondary objective of safety as measured by the incidence of treatment emergent adverse events
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01650870
|United States, Washington|
|Virginia Mason Medical Center|
|Seattle, Washington, United States, 98101|
|Principal Investigator:||Otto Lin, MD||Virginia Mason Medical Center|