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

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Benaroya Research Institute
• Collaborators: Cumberland Pharmaceuticals; Virginia Mason Hospital/Medical Center
• Treatments: Lactulose

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