Trial Outcomes & Findings for Effect of Cannabinoid Agonist on Gastrointestinal and Colonic Motor Functions in Patients With Irritable Bowel Syndrome (IBS) (NCT NCT01253408)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

36 participants

Primary outcome timeframe

24 hours

Results posted on

2013-05-07

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Dronabinol 2.5 mg Bid Dronabinol 2.5 mg will be taken orally with water twice per day for two days.	Dronabinol 5 mg Bid Dronabinol 5 mg will be taken orally with water twice per day for two days.	Placebo Placebo will be taken orally with water twice per day for two days.
Overall Study STARTED	10	13	13
Overall Study COMPLETED	10	12	13
Overall Study NOT COMPLETED	0	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Dronabinol 2.5 mg Bid Dronabinol 2.5 mg will be taken orally with water twice per day for two days.	Dronabinol 5 mg Bid Dronabinol 5 mg will be taken orally with water twice per day for two days.	Placebo Placebo will be taken orally with water twice per day for two days.
Overall Study Adverse Event	0	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dronabinol 2.5 mg Bid n=10 Participants Dronabinol 2.5 mg will be taken orally with water twice per day for two days.	Dronabinol 5 mg Bid n=13 Participants Dronabinol 5 mg will be taken orally with water twice per day for two days.	Placebo n=13 Participants Placebo will be taken orally with water twice per day for two days.	Total n=36 Participants Total of all reporting groups
Age Continuous	47.68 years STANDARD_DEVIATION 25.08 • n=5 Participants	42.28 years STANDARD_DEVIATION 16.36 • n=7 Participants	36.7 years STANDARD_DEVIATION 11.02 • n=5 Participants	41.77 years STANDARD_DEVIATION 17.74 • n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	11 Participants n=7 Participants	13 Participants n=5 Participants	34 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment United States	10 participants n=5 Participants	13 participants n=7 Participants	13 participants n=5 Participants	36 participants n=4 Participants
Body Mass Index (BMI)	28.7 kg/m^2 STANDARD_DEVIATION 1.5 • n=5 Participants	31.6 kg/m^2 STANDARD_DEVIATION 3.9 • n=7 Participants	30.8 kg/m^2 STANDARD_DEVIATION 1.8 • n=5 Participants	30.50 kg/m^2 STANDARD_DEVIATION 9.46 • n=4 Participants

PRIMARY outcome

Timeframe: 24 hours

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.

Outcome measures

Outcome measures
Measure	Dronabinol 2.5 mg Bid n=10 Participants Dronabinol 2.5 mg will be taken orally with water twice per day for two days.	Dronabinol 5 mg Bid n=13 Participants Dronabinol 5 mg will be taken orally with water twice per day for two days.	Placebo n=13 Participants Placebo will be taken orally with water twice per day for two days.
Colonic Transit Geometric Center at 24 Hours	3.12 units on a scale Standard Deviation 1.29	3.05 units on a scale Standard Deviation 1.02	2.77 units on a scale Standard Deviation 1.23

SECONDARY outcome

Timeframe: 28, 32, and 48 hours

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.

Outcome measures

Outcome measures
Measure	Dronabinol 2.5 mg Bid n=10 Participants Dronabinol 2.5 mg will be taken orally with water twice per day for two days.	Dronabinol 5 mg Bid n=13 Participants Dronabinol 5 mg will be taken orally with water twice per day for two days.	Placebo n=13 Participants Placebo will be taken orally with water twice per day for two days.
Colonic Transit Geometric Center 28 hours	3.39 units on a scale Standard Deviation 1.28	3.60 units on a scale Standard Deviation 1.04	3.24 units on a scale Standard Deviation 1.18
Colonic Transit Geometric Center 32 hours	3.78 units on a scale Standard Deviation 1.11	4.05 units on a scale Standard Deviation 0.90	3.54 units on a scale Standard Deviation 1.17
Colonic Transit Geometric Center 48 hours	4.21 units on a scale Standard Deviation 0.94	4.60 units on a scale Standard Deviation 0.65	4.02 units on a scale Standard Deviation 0.99

SECONDARY outcome

Timeframe: Approximately 2 hours after radiolabel meal is ingested

The time for half of the ingested solids or liquids to leave the stomach.

Outcome measures

Outcome measures
Measure	Dronabinol 2.5 mg Bid n=10 Participants Dronabinol 2.5 mg will be taken orally with water twice per day for two days.	Dronabinol 5 mg Bid n=13 Participants Dronabinol 5 mg will be taken orally with water twice per day for two days.	Placebo n=13 Participants Placebo will be taken orally with water twice per day for two days.
Gastric Emptying Half-Time (t1/2)	137.3 minutes Standard Deviation 33.53	130.7 minutes Standard Deviation 42.13	138.2 minutes Standard Deviation 45.18

SECONDARY outcome

Timeframe: 6 hours after radiolabeled meal was ingested

Percent of the radio-labeled meal that reached the colon at 6 hours, indirectly reflecting small bowel transit time.

Outcome measures

Outcome measures
Measure	Dronabinol 2.5 mg Bid n=10 Participants Dronabinol 2.5 mg will be taken orally with water twice per day for two days.	Dronabinol 5 mg Bid n=13 Participants Dronabinol 5 mg will be taken orally with water twice per day for two days.	Placebo n=13 Participants Placebo will be taken orally with water twice per day for two days.
Colonic Filling at 6 Hours	48.60 percentage of meal Standard Deviation 33.76	51.62 percentage of meal Standard Deviation 29.89	57.46 percentage of meal Standard Deviation 24.77

SECONDARY outcome

Timeframe: 48 hours after radiolabeled meal was ingested

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.

Outcome measures

Outcome measures
Measure	Dronabinol 2.5 mg Bid n=10 Participants Dronabinol 2.5 mg will be taken orally with water twice per day for two days.	Dronabinol 5 mg Bid n=13 Participants Dronabinol 5 mg will be taken orally with water twice per day for two days.	Placebo n=13 Participants Placebo will be taken orally with water twice per day for two days.
Ascending Colon Emptying T 1/2	9.50 hours Standard Deviation 4.62	9.90 hours Standard Deviation 5.44	14.53 hours Standard Deviation 8.36

SECONDARY outcome

Timeframe: 2, 4 hours

Proportion of stomach contents emptied at a 2 and 4 hours.

Outcome measures

Outcome measures
Measure	Dronabinol 2.5 mg Bid n=10 Participants Dronabinol 2.5 mg will be taken orally with water twice per day for two days.	Dronabinol 5 mg Bid n=13 Participants Dronabinol 5 mg will be taken orally with water twice per day for two days.	Placebo n=13 Participants Placebo will be taken orally with water twice per day for two days.
Gastric Emptying at 2 and 4 Hours 2 hours	0.38 proportion of stomach contents Standard Deviation 0.15	0.49 proportion of stomach contents Standard Deviation 0.17	0.45 proportion of stomach contents Standard Deviation 0.14
Gastric Emptying at 2 and 4 Hours 4 hours	0.90 proportion of stomach contents Standard Deviation 0.09	0.90 proportion of stomach contents Standard Deviation 0.13	0.88 proportion of stomach contents Standard Deviation 0.16

Adverse Events

Dronabinol 2.5 mg Bid

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Dronabinol 5 mg Bid

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Dronabinol 2.5 mg Bid n=10 participants at risk Dronabinol 2.5 mg will be taken orally with water twice per day for two days.	Dronabinol 5 mg Bid n=13 participants at risk Dronabinol 5 mg will be taken orally with water twice per day for two days.	Placebo n=13 participants at risk Placebo will be taken orally with water twice per day for two days.
Skin and subcutaneous tissue disorders Hot flushing	10.0% 1/10 • Number of events 1	0.00% 0/13	15.4% 2/13 • Number of events 2
General disorders Headache	30.0% 3/10 • Number of events 3	15.4% 2/13 • Number of events 2	15.4% 2/13 • Number of events 2
General disorders Dizziness/lightheadedness	20.0% 2/10 • Number of events 2	30.8% 4/13 • Number of events 4	7.7% 1/13 • Number of events 1
General disorders Drowsiness/tiredness	40.0% 4/10 • Number of events 4	38.5% 5/13 • Number of events 5	30.8% 4/13 • Number of events 4
General disorders "Loopy," foggy thinking	10.0% 1/10 • Number of events 1	15.4% 2/13 • Number of events 2	0.00% 0/13

Additional Information

Dr. Michael Camilleri

Mayo Clinic

Phone: 507-266-2306

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place