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Effect of Cannabinoid Agonist on Gastrointestinal and Colonic Motor Functions in Patients With Irritable Bowel Syndrome (IBS)

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ClinicalTrials.gov Identifier: NCT01253408
Recruitment Status : Completed
First Posted : December 3, 2010
Results First Posted : May 7, 2013
Last Update Posted : May 7, 2013
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Research Resources (NCRR)
Information provided by:
Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator)
Condition Irritable Bowel Syndrome
Interventions Drug: Dronabinol
Drug: Placebo
Enrollment 36
Recruitment Details All participants were recruited from a database of patients with irritable bowel syndrome (IBS) who reside within 150 miles of Rochester, Minnesota from October 2008 through April 2011.
Pre-assignment Details  
Arm/Group Title Dronabinol 2.5 mg Bid Dronabinol 5 mg Bid Placebo
Hide Arm/Group Description Dronabinol 2.5 mg will be taken orally with water twice per day for two days. Dronabinol 5 mg will be taken orally with water twice per day for two days. Placebo will be taken orally with water twice per day for two days.
Period Title: Overall Study
Started 10 13 13
Completed 10 12 13
Not Completed 0 1 0
Reason Not Completed
Adverse Event             0             1             0
Arm/Group Title Dronabinol 2.5 mg Bid Dronabinol 5 mg Bid Placebo Total
Hide Arm/Group Description Dronabinol 2.5 mg will be taken orally with water twice per day for two days. Dronabinol 5 mg will be taken orally with water twice per day for two days. Placebo will be taken orally with water twice per day for two days. Total of all reporting groups
Overall Number of Baseline Participants 10 13 13 36
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 13 participants 13 participants 36 participants
47.68  (25.08) 42.28  (16.36) 36.7  (11.02) 41.77  (17.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 13 participants 13 participants 36 participants
Female
10
 100.0%
11
  84.6%
13
 100.0%
34
  94.4%
Male
0
   0.0%
2
  15.4%
0
   0.0%
2
   5.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 13 participants 13 participants 36 participants
10 13 13 36
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 10 participants 13 participants 13 participants 36 participants
28.7  (1.5) 31.6  (3.9) 30.8  (1.8) 30.50  (9.46)
1.Primary Outcome
Title Colonic Transit Geometric Center at 24 Hours
Hide Description The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dronabinol 2.5 mg Bid Dronabinol 5 mg Bid Placebo
Hide Arm/Group Description:
Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
Dronabinol 5 mg will be taken orally with water twice per day for two days.
Placebo will be taken orally with water twice per day for two days.
Overall Number of Participants Analyzed 10 13 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.12  (1.29) 3.05  (1.02) 2.77  (1.23)
2.Secondary Outcome
Title Colonic Transit Geometric Center
Hide Description The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.
Time Frame 28, 32, and 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dronabinol 2.5 mg Bid Dronabinol 5 mg Bid Placebo
Hide Arm/Group Description:
Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
Dronabinol 5 mg will be taken orally with water twice per day for two days.
Placebo will be taken orally with water twice per day for two days.
Overall Number of Participants Analyzed 10 13 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
28 hours 3.39  (1.28) 3.60  (1.04) 3.24  (1.18)
32 hours 3.78  (1.11) 4.05  (0.90) 3.54  (1.17)
48 hours 4.21  (0.94) 4.60  (0.65) 4.02  (0.99)
3.Secondary Outcome
Title Gastric Emptying Half-Time (t1/2)
Hide Description The time for half of the ingested solids or liquids to leave the stomach.
Time Frame Approximately 2 hours after radiolabel meal is ingested
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dronabinol 2.5 mg Bid Dronabinol 5 mg Bid Placebo
Hide Arm/Group Description:
Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
Dronabinol 5 mg will be taken orally with water twice per day for two days.
Placebo will be taken orally with water twice per day for two days.
Overall Number of Participants Analyzed 10 13 13
Mean (Standard Deviation)
Unit of Measure: minutes
137.3  (33.53) 130.7  (42.13) 138.2  (45.18)
4.Secondary Outcome
Title Colonic Filling at 6 Hours
Hide Description Percent of the radio-labeled meal that reached the colon at 6 hours, indirectly reflecting small bowel transit time.
Time Frame 6 hours after radiolabeled meal was ingested
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dronabinol 2.5 mg Bid Dronabinol 5 mg Bid Placebo
Hide Arm/Group Description:
Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
Dronabinol 5 mg will be taken orally with water twice per day for two days.
Placebo will be taken orally with water twice per day for two days.
Overall Number of Participants Analyzed 10 13 13
Mean (Standard Deviation)
Unit of Measure: percentage of meal
48.60  (33.76) 51.62  (29.89) 57.46  (24.77)
5.Secondary Outcome
Title Ascending Colon Emptying T 1/2
Hide Description Ascending colon emptying t1/2 will be estimated by power exponential analysis of the proportionate emptying over time of counts from the colon. The primary data for this analysis will be the proportion of decay and depth-corrected counts in the ascending colon on the hourly scans on the first day of transit measurement and the 48 hour data.
Time Frame 48 hours after radiolabeled meal was ingested
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dronabinol 2.5 mg Bid Dronabinol 5 mg Bid Placebo
Hide Arm/Group Description:
Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
Dronabinol 5 mg will be taken orally with water twice per day for two days.
Placebo will be taken orally with water twice per day for two days.
Overall Number of Participants Analyzed 10 13 13
Mean (Standard Deviation)
Unit of Measure: hours
9.50  (4.62) 9.90  (5.44) 14.53  (8.36)
6.Secondary Outcome
Title Gastric Emptying at 2 and 4 Hours
Hide Description Proportion of stomach contents emptied at a 2 and 4 hours.
Time Frame 2, 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dronabinol 2.5 mg Bid Dronabinol 5 mg Bid Placebo
Hide Arm/Group Description:
Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
Dronabinol 5 mg will be taken orally with water twice per day for two days.
Placebo will be taken orally with water twice per day for two days.
Overall Number of Participants Analyzed 10 13 13
Mean (Standard Deviation)
Unit of Measure: proportion of stomach contents
2 hours 0.38  (0.15) 0.49  (0.17) 0.45  (0.14)
4 hours 0.90  (0.09) 0.90  (0.13) 0.88  (0.16)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dronabinol 2.5 mg Bid Dronabinol 5 mg Bid Placebo
Hide Arm/Group Description Dronabinol 2.5 mg will be taken orally with water twice per day for two days. Dronabinol 5 mg will be taken orally with water twice per day for two days. Placebo will be taken orally with water twice per day for two days.
All-Cause Mortality
Dronabinol 2.5 mg Bid Dronabinol 5 mg Bid Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dronabinol 2.5 mg Bid Dronabinol 5 mg Bid Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/13 (0.00%)      0/13 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dronabinol 2.5 mg Bid Dronabinol 5 mg Bid Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/10 (70.00%)      9/13 (69.23%)      7/13 (53.85%)    
General disorders       
Headache   3/10 (30.00%)  3 2/13 (15.38%)  2 2/13 (15.38%)  2
Dizziness/lightheadedness   2/10 (20.00%)  2 4/13 (30.77%)  4 1/13 (7.69%)  1
Drowsiness/tiredness   4/10 (40.00%)  4 5/13 (38.46%)  5 4/13 (30.77%)  4
"Loopy," foggy thinking   1/10 (10.00%)  1 2/13 (15.38%)  2 0/13 (0.00%)  0
Skin and subcutaneous tissue disorders       
Hot flushing   1/10 (10.00%)  1 0/13 (0.00%)  0 2/13 (15.38%)  2
Indicates events were collected by systematic assessment
This study included assessment of only four doses of dronabinol over 2 days.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Michael Camilleri
Organization: Mayo Clinic
Phone: 507-266-2306
Responsible Party: Dr. Michael Camilleri, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01253408     History of Changes
Other Study ID Numbers: 08-008314 Part A
R01DK079866 ( U.S. NIH Grant/Contract )
UL1RR024150 ( U.S. NIH Grant/Contract )
First Submitted: November 18, 2010
First Posted: December 3, 2010
Results First Submitted: February 4, 2013
Results First Posted: May 7, 2013
Last Update Posted: May 7, 2013