Clinical trial NCT00746395: Randomized, Placebo-controlled Trial of Lubiprostone as a Preparation for Capsule Endoscopy
Official title: Randomized, Placebo-controlled Trial of Lubiprostone as a Preparation for Capsule Endoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Inflammatory Bowel Disease
Keywords: capsule
endoscopy
prokinetic
lubiprostone
Normal
volunteers
Lead sponsor: University of South Alabama
Sponsor class: OTHER
Collaborators: name: Takeda
name: Sucampo Pharmaceuticals, Inc.
First posted: 2008-09-04
Enrollment: 45
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Gi disorders, gi surgery, cardiac, renal, or hepatic insufficiency, severe diarrhea

Primary outcomes:
measure: Complete Small Bowel Transit
timeFrame: 8 hours
Secondary outcomes:
measure: Small Bowel Transit
timeFrame: Duration of the test - 8 hours
Other outcomes:
Locations:
city: Mobile
country: United States
facility: USA Pavilion at Infirmary West
state: Alabama
Study officials:
affiliation: University of South Alabama
name: JAck A DiPalma, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hooks SB 3rd, Rutland TJ, Di Palma JA. Lubiprostone neither decreases gastric and small-bowel transit time nor improves visualization of small bowel for capsule endoscopy: a double-blind, placebo-controlled study. Gastrointest Endosc. 2009 Nov;70(5):942-6. doi: 10.1016/j.gie.2009.04.045. Epub 2009 Jul 4.