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

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

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.

Study Overview

• Status: Completed
• Conditions: Colonoscopy Preparation
• Intervention / Treatment: Drug: 90 grams of Crystalline Lactulose; Drug: 135 grams of Crystalline Lactulose; Drug: 180 grams of Crystalline Lactulose

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • ClinSearch, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cumberland Pharmaceuticals
• Investigators: Principal Investigator: Richard Krause, MD, ClinSearch, LLC

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: April 23, 2014
• First Submitted That Met QC Criteria: April 23, 2014
• First Posted (Estimate): April 25, 2014

Study Record Updates

• Last Update Posted (Estimate): February 24, 2016
• Last Update Submitted That Met QC Criteria: January 27, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Bowel Evacuation; Colonoscopy Preparation
• Additional Relevant MeSH Terms: Gastrointestinal Agents; Lactulose
• Other Study ID Numbers: CPI-KR-005