Lubiprostone Effects on Visceral Pain Sensitivity
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01166789|
Recruitment Status : Completed
First Posted : July 21, 2010
Last Update Posted : September 16, 2011
|Condition or disease||Intervention/treatment||Phase|
|Irritable Bowel Syndrome||Drug: Lubiprostone Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Lubiprostone Effects on Visceral Pain Sensitivity|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||August 2010|
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
- Pain threshold [ Time Frame: 2 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01166789
|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|