Clinical trial NCT02123017: Efficacy and Safety of Bisacodyl and Lactulose as a Preparation for Colonoscopy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colonoscopy Preparation
Keywords: Bowel Evacuation
Colonoscopy Preparation
Lead sponsor: Cumberland Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2014-04-25
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy of Bisacodyl and Lactulose as a Preparation for Colonoscopy.
timeFrame: 10-14 hours post last consumption
Secondary outcomes:
measure: Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Incidence
timeFrame: 1 day post last consumption
measure: Safety of Bisacodyl and Lactulose as a Bowel evacuant_AE Severity
timeFrame: 1 day post last consumption
measure: Tolerability of and Preference for Bisacodyl and Lactulose as a Bowel Evacuant
timeFrame: 1 day post last consumption
Other outcomes:
Locations:
city: Chattanooga
country: United States
facility: ClinSearch, LLC
state: Tennessee
Study officials:
affiliation: ClinSearch, LLC
name: Richard Krause, MD
role: PRINCIPAL_INVESTIGATOR
References: