Phase 2
Completed N=75
Effect of a Cannabinoid Agonist on Colonic Sensory Functions in Patients With Irritable Bowel Syndrome
Source: ClinicalTrials.gov NCT01786109 ↗Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Mar 2013
Primary outcomePrimary: Colonic Compliance at Pressure at Half-Maximum Volume (Pr 1/2) — 17.57; 16.2; 18.76 mL/mm Hg
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Colonic Compliance at Pressure at Half-Maximum Volume (Pr 1/2) |
17.57; 16.2; 18.76 | — |
| SECONDARY Postprandial Change in Colonic Tone |
30.34; 27.41; 26.31 | — |
| SECONDARY Post-treatment Sensory Threshold for First Perception of Pain |
42.83; 40.33; 44.44 | — |
| SECONDARY Post-Treatment Overall Sensory Rating in Response to 16, 24, 32, and 40 mm Hg Distensions |
38.18; 38.71; 37.0; 49.64; 42.75; 39.76 | — |
| SECONDARY Fasting Colonic Tone |
117.8; 118.5; 114.3 | — |
| SECONDARY Postprandial Colonic Motility Index |
11.24; 11.22; 10.70; 9.97; 10.23; 10.50 | — |
| SECONDARY Post-treatment Sensory Threshold for First Sensation |
15.83; 15.5; 18.37 | — |
| SECONDARY Post-Treatment Sensory Threshold for First Perception of Gas |
28.83; 27.33; 29.04 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01786109). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.