Effect of a Cannabinoid Agonist on Colonic Sensory Functions in Patients With Irritable Bowel Syndrome

Completed · Phase 2 · Has a placebo group

Conditions studied: Irritable Bowel Syndrome

In brief

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 in IBS. This study will investigate the effects of an approved medication, Dronabinol, on the movement of food through the stomach and colon in subjects with a history of diarrhea-predominant Irritable Bowel Syndrome (D-IBS).

Key facts

Study ID

NCT01786109

Run by

Michael Camilleri

People needed

75

Starts

2009-09-01

Expected to finish

2011-12-01

Last updated by the study team

2013-03-14

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-75 years
• Positive for IBS symptoms by Rome III criteria
• No prior abdominal surgery (except appendectomy or cholecystectomy
• Score of 10 or less on either Anxiety or Depression on the Hospital Anxiety/Depression Inventory

You may not qualify if…

• Patients with significant depression (score of greater than 10 on Hospital Depression Inventory
• Patients with anxiety (score of greater than 10 on Hospital Anxiety Inventory. However, patients on stable doses of selective serotonin inhibitors (SSRIs) or low dose of tricyclic antidepressants will be eligible.

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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