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

This study has been completed.
Sponsor:
Collaborators:
Takeda
Sucampo Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Jack DiPalma, University of South Alabama
ClinicalTrials.gov Identifier:
NCT00746395
First received: September 3, 2008
Last updated: November 7, 2016
Last verified: November 2016
  Purpose
This investigation is designed to compare lubiprostone and placebo for cleansing and propulsion in preparation for capsule endoscopy.

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

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

Resource links provided by NLM:


Further study details as provided by Jack DiPalma, University of South Alabama:

Primary Outcome Measures:
  • Complete Small Bowel Transit [ Time Frame: 8 hours ]
    Percent of subjects with capsule passage through small bowel


Secondary Outcome Measures:
  • Small Bowel Transit [ Time Frame: Duration of the test - 8 hours ]
    Small bowel transit time


Enrollment: 45
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: lubiprostone 24mcg single dose
lubiprostone 24mcg single dose po prior to capsule endoscopy
Drug: Lubiprostone
24 mcg oral administration
Other Name: Amitiza
Placebo Comparator: Sugar pill
Placebo (sugar pill) - matched single dose po prior to capsule endoscopy
Drug: Placebo
Oral administration
Other Name: Sugar pill

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

Ages Eligible for Study:   19 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Sucampo Pharmaceuticals, Inc.
Investigators
Principal Investigator: JAck A DiPalma, MD University of South Alabama
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jack DiPalma, Professor of Medicine, University of South Alabama
ClinicalTrials.gov Identifier: NCT00746395     History of Changes
Other Study ID Numbers: 07-096
Study First Received: September 3, 2008
Results First Received: August 15, 2013
Last Updated: November 7, 2016

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

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Lubiprostone
Chloride Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2017