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
1 other identifier
interventional
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2014
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 23, 2014
CompletedFirst Posted
Study publicly available on registry
April 25, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedResults Posted
Study results publicly available
February 24, 2016
CompletedFebruary 24, 2016
January 1, 2016
4 months
April 23, 2014
December 18, 2015
January 27, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Incidence
1 day post last consumption
Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Severity
1 day post last consumption
Tolerability of and Preference for Bisacodyl and Lactulose as a Bowel Evacuant
1 day post last consumption
Study Arms (3)
90 grams of Crystalline Lactulose
EXPERIMENTAL15 mg of bisacodyl, plus 30 grams of crystalline lactulose x three doses
135 grams of Crystalline Lactulose
EXPERIMENTAL15 mg of bisacodyl, plus 45 grams of crystalline lactulose x three doses
180 grams of Crystalline Lactulose
EXPERIMENTAL15 mg of bisacodyl, plus 60 grams of crystalline lactulose x three doses
Interventions
15 mg of bisacodyl, plus 30 grams crystalline lactulose x 3 doses
15 mg of bisacodyl, plus 45 grams crystalline lactulose x 3 doses
15 mg of bisacodyl, plus 60 grams crystalline lactulose x 3 doses
Eligibility Criteria
You may qualify if:
- Patients requiring bowel evacuation for colonoscopy.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ClinSearch, LLC
Chattanooga, Tennessee, 37421, United States
Results Point of Contact
- Title
- Amy Rock, PhD
- Organization
- Cumberland Pharmaceuticals, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Krause, MD
ClinSearch, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2014
First Posted
April 25, 2014
Study Start
April 1, 2014
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
February 24, 2016
Results First Posted
February 24, 2016
Record last verified: 2016-01