Status:
COMPLETED
Lubiprostone Effects on Visceral Pain Sensitivity
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Takeda
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this research study is to determine how Lubiprostone, a medication used to treat irritable bowel syndrome with constipation predominant symptoms (IBS-C), works to reduce clinical pain. ...
Detailed Description
Subjects will be enrolled in an 8-week study requiring a total of 7 visits to the UNC Center for Clinical and Translational Research. The protocol is divided into 4 two-week periods: (1) Two-week base...
Eligibility Criteria
Inclusion
- clinical diagnosis of IBS-C
- meeting Rome III diagnostic criteria for IBS-C
- age 18 or older
Exclusion
- use of laxatives or prokinetics within two weeks prior to the study or during the study
- use of IBS-specific compounds, opiates, anticholinergics, or any drug likely to cause constipation as a side-effect
- use of analgesics for 48 hours prior to the study
- hypothyroid condition
- history of bowel resection except appendectomy or cholecystectomy
- psychotic disorder, major depression, substance abuse (other than tobacco), or other psychiatric condition likely to interfere with the conduct of the study. Subjects treated for depression more than 2 years ago or for situational circumstances may be eligible for the study at the investigator's discretion
- renal disease
- inflammatory or ischemic disease of the rectum
- known to be an unreliable subject
- Because this study involves exposure to radiation, subjects who are pregnant or planning to become pregnant, employees currently working with radiation, and subjects who have participated in research involving radiation within the past year will also be excluded.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT01166789
Start Date
February 1 2008
End Date
August 1 2010
Last Update
September 16 2011
Active Locations (1)
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1
UNC Clinical and Translational Research Center
Chapel Hill, North Carolina, United States, 27599