ClinSearch, LLC
Chattanooga, Tennessee, 37421, United States
NCT Number: NCT02123017
The purpose of the study is to evaluate the efficacy and safety of bisacodyl combined with escalating doses of lactulose to be used as a preparation for colonoscopy.
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Notify Me18 year and older
All sexes
Interventional
Phase 2
Chattanooga, Tennessee, 37421, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
15 mg of bisacodyl, plus 30 grams crystalline lactulose x 3 doses
15 mg of bisacodyl, plus 45 grams crystalline lactulose x 3 doses
15 mg of bisacodyl, plus 60 grams crystalline lactulose x 3 doses
Time frame: 10-14 hours post last consumption
Efficacy assessed by the physician's determination of the cleanliness of the colon using the Boston Bowel Preparation Scale (BBPS). 9 is the maximum score, representing an fully cleansed colon; 0 is the minimal score, representing a colon with no cleaning.
Time frame: 1 day post last consumption
Safety determined by the incidence of treatment emergent adverse events.
Time frame: 1 day post last consumption
Safety determined by the severity of treatment emergent adverse events.
Time frame: 1 day post last consumption
Tolerability assessed by a patient questionnaire. Overall tolerability as given by Visual Analog Scale (VAS): 100 represents maximally tolerable; 0 represents minimally tolerable
Cumberland Pharmaceuticals
Industry
An Observer-blinded, Dose-finding Study to Investigate the Safety, Efficacy, and Patient Preference of Lactulose for Oral Solution With Bisacodyl for Cleansing of the Colon as a Preparation for Colonoscopy in Adults
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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