At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 75 enrolled

Drug / intervention

Dronabinol +1 moredrug

Likely dose

Dronabinol 2.5 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01786109

NCT01786109Phase 2Completed

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Study on the Effect of Cannabinoid Agonist on Gastrointestinal and Colonic Motor and Sensory Functions in Patients With Diarrhea-Predominant Irritable Bowel Syndrome

Michael Camilleri·interventional·Posted Feb 7, 2013·Updated Mar 14, 2013

In Brief

A Phase 2 clinical trial evaluating Dronabinol and Placebo for Irritable Bowel Syndrome. Completed, enrolled 75 participants across 1 site.

Detailed 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 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).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsIrritable Bowel Syndrome

CountriesUnited States

CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Center for Research Resources (NCRR)

Timeline

Phase 2CompletedFinished

20102011201220132014201520162017201820192020202120222023202420252026

Enrollment StartSep 2009

Primary CompletionDec 2011

First PostedFeb 2013

TodayJul 2026

First PostedFeb 7, 2013

Enrollment StartSep 1, 2009

Primary CompletionDec 1, 2011

TodayJul 2, 2026

Enrollment to primary: 2.3 yearsPosted 13.4 years ago

Interventions

Dronabinoldrug

Dronabinol is a synthetic delta-9-tetrahydrocannabinol, a nonselective cannabinoid agonist. Subjects received one dose of either 2.5 mg or 5 mg orally with water.

Placebodrug

Placebo will match study drug; taken as one dose orally with water.