NCT01650870

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Benaroya Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Crystalline Lactulose

Timeline

• Start date: 2012-07-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2012-07-26
• Last updated: 2014-08-08

Locations

1 site across 1 country: United States