Lubiprostone Effects on Visceral Pain Sensitivity
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. Lubiprostone acts in the small intestine to cause an increase in the secretion of chloride, water and sodium. The increased fluid causes food residue to move through the bowel more quickly and makes the stools softer. First, we want to test the idea that Lubiprostone works by making a person less sensitive to pain. Second, we want to confirm that Lubiprostone decreases the time it takes fecal matter to travel through your GI tract, referred to as transit time.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Lubiprostone Effects on Visceral Pain Sensitivity|
- Pain threshold [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||February 2008|
|Study Completion Date:||August 2010|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Lubiprostone
Lubiprostone 48ug taken daily for 14 days.
48ug daily taken as 24ug capsules twice per day, in morning and evening.
Other Name: Amitiza
Placebo Comparator: Placebo
2 capsules containing a substance with no active ingredient taken daily for 14 days.
2 capsules daily, taken in morning and evening
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 baseline diary symptom monitoring, followed by a barostat test of pain sensitivity. (2) Two-week treatment with either Lubiprostone or placebo, with daily symptom diary recording and barostat test of pain sensitivity at the end. In addition, patients will be tested for whole gut transit time by the radio-opaque marker (Sitzmark) technique in the second week. (3) Two-week washout period, during which patients will continue the symptom diary. (4) Two-week crossover to Lubiprostone or placebo, identical to the second two-week period.
|United States, North Carolina|
|UNC Clinical and Translational Research Center|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||William E Whitehead, PhD||University of North Carolina, Chapel Hill|