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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

September 3, 2008
August 5, 2011
April 2008
September 2008   (final data collection date for primary outcome measure)
Complete small bowel transit [ Time Frame: end of study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00746395 on ClinicalTrials.gov Archive Site
Cleansing preparation [ Time Frame: end of study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Randomized, Placebo-controlled Trial of Lubiprostone as a Preparation for Capsule Endoscopy
Randomized, Placebo-controlled Trial of Lubiprostone as a Preparation for Capsule Endoscopy

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

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Inflammation Bowel Disease
  • Drug: Lubiprostone
    24 mcg oral administration
    Other Name: Amitiza
  • Drug: Placebo
    Oral administration
  • Active Comparator: 1
    lubiprostone
    Intervention: Drug: Lubiprostone
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
September 2008
September 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy volunteers

Exclusion Criteria:

  • Gi disorders, gi surgery, cardiac, renal, or hepatic insufficiency, severe diarrhea
Both
19 Years to 90 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00746395
07-096
No
Jack A. Di Palma, MD, University of South Alabama
University of South Alabama
  • Takeda Global Research & Development Center, Inc.
  • Sucampo Pharmaceuticals, Inc.
Principal Investigator: JAck A DiPalma, MD University of South Alabama
University of South Alabama
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP