NCT00746395

Randomized, Placebo-controlled Trial of Lubiprostone as a Preparation for Capsule Endoscopy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: University of South Alabama · Academic / Other
• Sex: All
• Age: 19 Years – 90 Years
• Healthy volunteers: Accepted

Summary

This investigation is designed to compare lubiprostone and placebo for cleansing and propulsion in preparation for capsule endoscopy.

Detailed description

Introduction of small bowel capsule endoscopy made available an unique technique for diagnostic evaluation of the gastrointestinal tract. After esophagogastroduodenoscopy and colonoscopy about 5% of bleeding cases remain unexplained and capsule endoscopy provides small bowel yield. Capsule endoscopy has special application for evaluation of inflammation bowel disease and other small bowel conditions. Several adjuncts are used to enhance the examination by improving cleansing preparation or propulsion. Metoclopramide, tegaserod, simethicone, erythromycin, phosphates and polyethylene glycol (PEG) colon cleansing agents have been tried and some show improved visualization or increased propulsion where more capsules reach to colonic cecum while still recording within the limits of its 8 hour battery. Recently, our group had an observational report of our experience showing that either full bowel cleansing preparation or prokinetics such as metoclopramide or tegaserod enhanced visualization and functioning capsule transit to the colon. Lubiprostone is a novel chloride channel activator that increases intestinal fluid secretion and motility. It is FDA approved and indicated for treatment of chronic idiopathic constipation. This investigation is designed to compare lubiprostone and placebo for cleansing and propulsion in preparation for capsule endoscopy. The FDA approved 24 mcg constipation dose was chosen because other medications used in similar single dose in our pilot studies appear effective.

Conditions

• Inflammatory Bowel Disease

Interventions

Type	Name	Description
DRUG	Lubiprostone	24 mcg oral administration
DRUG	Placebo	Oral administration

Timeline

• Start date: 2008-04-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2008-09-04
• Last updated: 2020-10-08
• Results posted: 2017-01-04

Locations

1 site across 1 country: United States