NCT01324284

Comparative Study of Lubiprostone and PEG Preparation Versus Conventional PEG Preparation for Colonoscopy

Comparative Study of Lubiprostone and PEG Preparation Versus Conventional PEG Preparation to Enhance the Colonoscopy Preparation Quality in an Indian Tertiary Care Center.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 442 (actual)
• Sponsor: Asian Institute of Gastroenterology, India · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Lubiprostone as an adjunct to the standard bowel preparation regime the quality of bowel preparation can be improved for a good colonoscopic examination without missing lesions and complications.

Detailed description

Objectives: 1. Primary: * Same day Low volume PEG with placebo (Arm 1) versus same day low volume PEG with Lubiprostone (Arm 2) * Waiting time for colonoscopic procedure and quality of bowel preparation 2. Secondary: * Quality of bowel preparation without Dietary restriction (Modified bowel preparation regime without Fiber diet restrictions)

Conditions

• Colorectal Carcinoma

Interventions

Type	Name	Description
DRUG	Lubiprostone	Lubiprostone is a chloride channel activator approved by the Food and Drug Administration for the treatment of chronic constipation. A randomized, double-blind, parallel-group, placebo-controlled study evaluating the effect of lubiprostone on gastric function showed slowed gastric emptying and increased small bowel and colonic transit time. Peak plasma concentration was shown to be around 1.14 hours, with a majority of the drug excreted in the urine within 48 hours.

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2011-03-29
• Last updated: 2013-04-05