Efficacy and Safety of Bisacodyl and Lactulose as a Preparation for Colonoscopy

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Colonoscopy Preparation

Intervention / Treatment
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* Drug: 90 grams of Crystalline Lactulose
* Drug: 135 grams of Crystalline Lactulose
* Drug: 180 grams of Crystalline Lactulose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients requiring bowel evacuation for colonoscopy. Exclusion Criteria: Patients with galactosemia (galactose-sensitive diet). Patients known to be hypersensitive to any of the components of lactulose for oral solution. Patients with a known abnormality on screening or a vital sign assessments that, in the Investigator's judgment, may pose a significant risk including those pertaining to dehydration or electrolyte shifts. Patients with a history of impaired renal function. Patients with current or recent history of hypotension, as defined by the Investigator. Patients with a history of long Q-T syndrome. Patients with a history of a failed bowel preparation. Patients with severe constipation, defined as those patients taking daily prescription or over-the-counter laxatives. Patients with possible bowel obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon, ileus or previous colonic surgery (except hemorrhoidectomy and polypectomy). Patients on lactulose therapy or receiving any treatment for chronic constipation. Be pregnant or nursing. Patients expected to require electrocautery or argon plasma coagulation. Patients less than 18 years of age. Inability to understand the requirements of the study or be unwilling to provide written informed consent (as evidenced by signature on an informed consent document approved by an Institutional Review Board [IRB]) and agree to abide by the study restrictions. Be otherwise unsuitable for the study, in the opinion of the Investigator.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 90 grams of Crystalline Lactulose<br>15 mg of bisacodyl, plus 30 grams of crystalline lactulose x three doses | Drug: 90 grams of Crystalline Lactulose<br>* 15 mg of bisacodyl, plus 30 grams crystalline lactulose x 3 doses<br>|
| Experimental: 135 grams of Crystalline Lactulose<br>15 mg of bisacodyl, plus 45 grams of crystalline lactulose x three doses | Drug: 135 grams of Crystalline Lactulose<br>* 15 mg of bisacodyl, plus 45 grams crystalline lactulose x 3 doses<br>|
| Experimental: 180 grams of Crystalline Lactulose<br>15 mg of bisacodyl, plus 60 grams of crystalline lactulose x three doses | Drug: 180 grams of Crystalline Lactulose<br>* 15 mg of bisacodyl, plus 60 grams crystalline lactulose x 3 doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Bisacodyl and Lactulose as a Preparation for Colonoscopy. | 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. | 10-14 hours post last consumption | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Incidence | Safety determined by the incidence of treatment emergent adverse events. | 1 day post last consumption | 
| Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Severity | Safety determined by the severity of treatment emergent adverse events. | 1 day post last consumption | 
| Tolerability of and Preference for Bisacodyl and Lactulose as a Bowel Evacuant | Tolerability assessed by a patient questionnaire. Overall tolerability as given by Visual Analog Scale (VAS): 100 represents maximally tolerable; 0 represents minimally tolerable | 1 day post last consumption | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bowel Evacuation, Colonoscopy Preparation