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

This study has been completed.
Sponsor:
Collaborators:
Takeda Global Research & Development Center, Inc.
Sucampo Pharmaceuticals, Inc.
Information provided by:
University of South Alabama
ClinicalTrials.gov Identifier:
NCT00746395
First received: September 3, 2008
Last updated: August 5, 2011
Last verified: August 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Inflammation Bowel Disease
 Drug: Lubiprostone
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: Randomized, Placebo-controlled Trial of Lubiprostone as a Preparation for Capsule Endoscopy

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Further study details as provided by University of South Alabama:

Primary Outcome Measures:
  • Complete small bowel transit [ Time Frame: end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cleansing preparation [ Time Frame: end of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: April 2008
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
lubiprostone
 Drug: Lubiprostone
24 mcg oral administration
Other Name: Amitiza
Placebo Comparator: 2
Placebo
 Drug: Placebo
Oral administration

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 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

Ages Eligible for Study:   19 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers

Exclusion Criteria:

  • Gi disorders, gi surgery, cardiac, renal, or hepatic insufficiency, severe diarrhea
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00746395

Locations
United States, Alabama
USA Pavilion at Infirmary West
Mobile, Alabama, United States, 36693
Sponsors and Collaborators
University of South Alabama
Takeda Global Research & Development Center, Inc.
Sucampo Pharmaceuticals, Inc.
Investigators
Principal Investigator: JAck A DiPalma, MD University of South Alabama
  More Information

No publications provided

Responsible Party: Jack A. Di Palma, MD, University of South Alabama
ClinicalTrials.gov Identifier: NCT00746395     History of Changes
Other Study ID Numbers: 07-096
Study First Received: September 3, 2008
Last Updated: August 5, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of South Alabama:
capsule
endoscopy
prokinetic
 lubiprostone
Normal
volunteers

Additional relevant MeSH terms:
Inflammation
Intestinal Diseases
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 16, 2013