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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: August 2014

Interventions

  • Drug: 90 grams of Crystalline Lactulose
    • 15 mg of bisacodyl, plus 30 grams crystalline lactulose x 3 doses
  • Drug: 135 grams of Crystalline Lactulose
    • 15 mg of bisacodyl, plus 45 grams crystalline lactulose x 3 doses
  • Drug: 180 grams of Crystalline Lactulose
    • 15 mg of bisacodyl, plus 60 grams crystalline lactulose x 3 doses

Arms, Groups and Cohorts

  • Experimental: 90 grams of Crystalline Lactulose
    • 15 mg of bisacodyl, plus 30 grams of crystalline lactulose x three doses
  • Experimental: 135 grams of Crystalline Lactulose
    • 15 mg of bisacodyl, plus 45 grams of crystalline lactulose x three doses
  • Experimental: 180 grams of Crystalline Lactulose
    • 15 mg of bisacodyl, plus 60 grams of crystalline lactulose x three doses

Clinical Trial Outcome Measures

Primary Measures

  • Efficacy of Bisacodyl and Lactulose as a Preparation for Colonoscopy.
    • 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.

Secondary Measures

  • Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Incidence
    • Time Frame: 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
    • Time Frame: 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
    • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Cumberland Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Richard Krause, MD, Principal Investigator, ClinSearch, LLC

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