Randomized, Placebo-controlled Trial of Lubiprostone as a Preparation for Capsule Endoscopy
1 other identifier
interventional
45
1 country
1
Brief Summary
This investigation is designed to compare lubiprostone and placebo for cleansing and propulsion in preparation for capsule endoscopy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2008
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 3, 2008
CompletedFirst Posted
Study publicly available on registry
September 4, 2008
CompletedResults Posted
Study results publicly available
January 4, 2017
CompletedOctober 8, 2020
September 1, 2020
5 months
September 3, 2008
August 15, 2013
September 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete Small Bowel Transit
Percent of subjects with capsule passage through small bowel
8 hours
Secondary Outcomes (1)
Small Bowel Transit
Duration of the test - 8 hours
Study Arms (2)
lubiprostone 24mcg single dose
ACTIVE COMPARATORlubiprostone 24mcg single dose po prior to capsule endoscopy
Sugar pill
PLACEBO COMPARATORPlacebo (sugar pill) - matched single dose po prior to capsule endoscopy
Interventions
Eligibility Criteria
You may qualify if:
- Healthy volunteers
You may not qualify if:
- Gi disorders, gi surgery, cardiac, renal, or hepatic insufficiency, severe diarrhea
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of South Alabamalead
- Takedacollaborator
- Sucampo Pharmaceuticals, Inc.collaborator
Study Sites (1)
USA Pavilion at Infirmary West
Mobile, Alabama, 36693, United States
Related Publications (1)
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.
PMID: 19577749DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Study participant enrollment met per protocol requirement.
Results Point of Contact
- Title
- Jack A. DiPalma, M.D.
- Organization
- University of South Alabama
Study Officials
- PRINCIPAL INVESTIGATOR
JAck A DiPalma, MD
University of South Alabama
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 3, 2008
First Posted
September 4, 2008
Study Start
April 1, 2008
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
October 8, 2020
Results First Posted
January 4, 2017
Record last verified: 2020-09