Safety, Efficacy, and Patient Preference of Split-Dose Crystalline Lactulose as a Preparation for Colonoscopy in Adults

NCT ID: NCT01650870

Last Updated: 2014-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2012-09-30

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.

Conditions

Colonoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Evening Only (full-dose)

The dosing regimen of Crystalline lactulose will be four 45-gram doses (one dose every 60 minutes for 4 straight hours) taken the evening before the colonoscopy procedure.

Group Type: ACTIVE_COMPARATOR

Crystalline Lactulose

Intervention Type: DRUG

Split-dose

The dosing regimen of Crystalline lactulose will be three 45-gram doses (one dose every 60 minutes for 3 straight hours) taken the evening before the colonoscopy procedure followed by one 45-gram dose the morning before the colonoscopy procedure.

Group Type: EXPERIMENTAL

Crystalline Lactulose

Intervention Type: DRUG

Interventions

Crystalline Lactulose

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Mason Hospital/Medical Center

OTHER

Sponsor Role: collaborator

Cumberland Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Benaroya Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Otto Lin, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Mason Medical Center

Locations

Virginia Mason Medical Center

Seattle, Washington, United States

Countries

United States

Other Identifiers

SplitDose Cryst. Lactulose

Identifier Type: -

Identifier Source: org_study_id