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

Colonoscopy Preparation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02123017
• Other study ID #: CPI-KR-005
• Status: Completed
• Phase: Phase 2
• First received: April 23, 2014
• Last updated: January 27, 2016
• Start date: April 2014
• Est. completion date: August 2014

Study information

• Verified date: January 2016
• Source: Cumberland Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonoscopy Preparation

Intervention

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

Locations

Country	Name	City	State
United States	ClinSearch, LLC	Chattanooga	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Cumberland Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	No