Clinical trial NCT01650870: Safety, Efficacy, and Patient Preference of Split-Dose Crystalline Lactulose as a Preparation for Colonoscopy in Adults
Official title: A Single Center, Randomized, Single-blind Pilot Study to Determine the Safety, Efficacy, and Patient Preference of Split-Dose Regimen of Crystalline Lactulose for Cleansing of the Colon as a Preparation for Colonoscopy in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colonoscopy
Keywords: Cathartics
Laxatives
Lactulose
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Lead sponsor: Benaroya Research Institute
Sponsor class: OTHER
Collaborators: name: Virginia Mason Hospital/Medical Center
name: Cumberland Pharmaceuticals
First posted: 2012-07-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy of a split-dose regimen of crystalline lactulose for cleansing of the colon as a preparation for colonoscopy, as assessed by the physician's determination of the cleanliness of the colon using the Boston Bowel Prep Scale (BBPS).

Detailed description: This is a single center, open-label, pilot study to determine the safety, efficacy, and patient preference of a split-dose regimen of Crystalline Lactulose for cleansing of the colon prior to colonoscopy. Safety will be assessed by the occurrence of any treatment emergent adverse events. Efficacy will be determined by the endoscopist's rating of the cleanliness of the colon and the incidence of treatment failure (insufficient evacuation of the bowel). Patient preference will be determined by the patient's responses on a patient questionnaire.

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 Crystalline Lactulose
* 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, previous colonic surgery, gastric retention, bowel perforation, toxic colitis, toxic megacolon, or ileus
* Patients on lactulose therapy or receiving any treatment for chronic constipation
* 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 pregnant or nursing
* Be otherwise unsuitable for the study, in the opinion of the Investigator

Primary outcomes:
measure: Cleanliness of the Colon During Colonoscopy
timeFrame: Day of the procedure
Secondary outcomes:
measure: Treatment Failures
timeFrame: Day of the procedure
measure: Patient Tolerability and Preference
timeFrame: Day before and day of colonoscopy
measure: Colonic Hydrogen and Methane Gas Production
timeFrame: Day of colonoscopy
measure: Safety/Adverse Events
timeFrame: Day before colonoscopy till 7 days after colonoscopy
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
Study officials:
affiliation: Virginia Mason Medical Center
name: Otto Lin, MD
role: PRINCIPAL_INVESTIGATOR
References: