Clinical trial NCT01887470: 2 Regimens of Lactulose for Colonoscopy Preparation in Adults
Official title: A Randomized, Single-blind Pilot Study to Determine the Safety, Efficacy, and Patient Preference of 2 Regimens of Lactulose 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: 2013-06-26
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine the efficacy of 2 regimens of lactulose as a preparation for colonoscopy.

Detailed description: A full-dose regimen of lactulose for oral solution, where all dosing is completed the evening prior to the colonoscopy procedure, will be studied and compared to a split-dose regimen, where three doses are taken on the prior evening, and one dose is taken the morning of the procedure.

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 an abnormality on screening blood work or 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.
* Patients on lactulose therapy or receiving any treatment for chronic constipation.
* Be pregnant or nursing.
* Patients with known large polyps or flat polyps (i.e. polyps requiring 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 Lactulose as a Preparation for Colonoscopy.
timeFrame: at least 3 hours post last consumption
Secondary outcomes:
measure: Incidence of Treatment Failure
timeFrame: at least 3 hours post last consumption
measure: Tolerability of and Preference for Lactulose as a Bowel Evacuant-Patient Visual Analog Scale (VAS)
timeFrame: 3 - 15 hours post last consumption
measure: Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 1
timeFrame: 3-15 hours post last consumption
measure: Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 2
timeFrame: 3-15 hours post last consumption
measure: Tolerability of and Preference for Lactulose as a Bowel Evacuant-Likert 3
timeFrame: 3 - 15 hours post last consumption
measure: Tolerability of and Preference for Lactulose as a Bowel Evacuant
timeFrame: 3 - 15 hours post last consumption
measure: Tolerability of and Preference for Lactulose as a Bowel Evacuant
timeFrame: 3 to 15 hours post last consumption
measure: Colonic Hydrogen Gas Levels
timeFrame: 3 - 15 hours post last consumption
measure: Colonic Methane Gas Levels
timeFrame: 3 - 15 hours post last consumption
Other outcomes:
Locations:
city: Chattanooga
country: United States
facility: ClinSearch, LLC
state: Tennessee
Study officials:
affiliation: ClinSearch, LLC
name: Richard Krause, M.D
role: PRINCIPAL_INVESTIGATOR
References: