Safety, Efficacy, and Patient Preference of Split-Dose Crystalline Lactulose as a Preparation for Colonoscopy in Adults
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|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
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): NCT01650870
|United States, Washington|
|Virginia Mason Medical Center|
|Seattle, Washington, United States, 98101|
|Principal Investigator:||Otto Lin, MD||Virginia Mason Medical Center|