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

Phase 2

Completed

Interventions: Drug: 90 grams of Crystalline Lactulose
Drug: 135 grams of Crystalline Lactulose
Drug: 180 grams of Crystalline Lactulose

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
90 grams of Crystalline Lactulose	90 grams of Crystalline Lactulose	15 mg of bisacodyl, plus 30 grams of crystalline lactulose x three doses
135 grams of Crystalline Lactulose	135 grams of Crystalline Lactulose	15 mg of bisacodyl, plus 45 grams of crystalline lactulose x three doses
180 grams of Crystalline Lactulose	180 grams of Crystalline Lactulose	15 mg of bisacodyl, plus 60 grams of crystalline lactulose x three doses

Primary Outcome Measures

Name	Time	Method
Efficacy of Bisacodyl and Lactulose as a Preparation for Colonoscopy.	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.

Secondary Outcome Measures

Name	Time	Method
Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Incidence	1 day post last consumption	Safety determined by the incidence of treatment emergent adverse events.
Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Severity	1 day post last consumption	Safety determined by the severity of treatment emergent adverse events.
Tolerability of and Preference for Bisacodyl and Lactulose as a Bowel Evacuant	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