Status:
COMPLETED
Effect of Cannabinoid Agonist on Gastrointestinal and Colonic Motor Functions in Patients With Irritable Bowel Syndrome (IBS)
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Research Resources (NCRR)
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Irritable bowel syndrome (IBS) affects about 15% of the U.S. population. There are still no effective and safe medications approved for the treatment of abdominal pain associated with bowel symptoms i...
Detailed Description
Irritable bowel syndrome (IBS) affects about 15% of the U.S. population. Despite increasing understanding of the pathophysiology of IBS, there are unmet clinical needs and no effective medication appr...
Eligibility Criteria
Inclusion
- Age 18-75 years
- Positive for IBS symptoms by Rome III criteria
- No prior abdominal surgery (except appendectomy or cholecystectomy)
- Baseline Geometric Center at 24 hours is greater/equal to 2.0
- Baseline Geometric Center at 48 hours is greater/equal to 3.9
Exclusion
- Patients with significant depression (score of greater than 10 on Hospital and Anxiety Inventory)
- Patients with anxiety (score of greater than 10 on Hospital and Anxiety Inventory) will not be allowed to participate. However, patients on stable doses of selective serotonin re-uptake inhibitors (SSRIs) or low dose of tricyclic antidepressants will be eligible.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01253408
Start Date
September 1 2009
End Date
December 1 2011
Last Update
May 7 2013
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905