Trial Outcomes & Findings for The Effects of Cannabinoid on Patients With Non-GERD Related Non Cardiac Chest Pain (NCT NCT01598207)

Results Overview

Number of people still experiencing the same amount of chest pain during treatment than previously without

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

13 participants

Primary outcome timeframe

Baseline and 1 month

Results posted on

2017-04-28

Participant Flow

Participant milestones

Participant milestones
Measure	Marinol Marinol: 5mg BID, orally for 1 month	Placebo Placebo: 5mg BID, orally for 1 month
Overall Study STARTED	7	6
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effects of Cannabinoid on Patients With Non-GERD Related Non Cardiac Chest Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Marinol n=7 Participants Marinol: 5mg BID, orally for 1 month	Placebo n=6 Participants Placebo: 5mg BID, orally for 1 month	Total n=13 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants	6 participants n=7 Participants	13 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 1 month

Number of people still experiencing the same amount of chest pain during treatment than previously without

Outcome measures

Outcome measures
Measure	Marinol n=6 Participants Marinol: 5mg BID, orally for 1 month	Placebo n=6 Participants Placebo: 5mg BID, orally for 1 month
Frequency of Chest Pain Episodes	1 participants	3 participants

SECONDARY outcome

Timeframe: 1 month

Population: 1 participant in placebo did not have this information completed

Total (intensity (0(none) - 3(severe) + duration (0(none) - 3(longer than 30 mins)) at end of 1 month treatment; higher represents worse outcome; the total score ranges from 0 to 6 and is the sum of the intensity and duration

Outcome measures

Outcome measures
Measure	Marinol n=6 Participants Marinol: 5mg BID, orally for 1 month	Placebo n=5 Participants Placebo: 5mg BID, orally for 1 month
Frequency of Chest Pain in Treatment Group vs Baseline	1.87 units on a scale Standard Deviation 2.58	1.8 units on a scale Standard Deviation 1.64

SECONDARY outcome

Timeframe: Baseline and 1 month

Population: 1 participant in placebo did not have this information completed

Intensity (0(none) - 3(severe)) at baseline vs 1 month for chest pain episodes; higher represents worse outcome; multiple chest pain totals are averaged

Outcome measures

Outcome measures
Measure	Marinol n=6 Participants Marinol: 5mg BID, orally for 1 month	Placebo n=5 Participants Placebo: 5mg BID, orally for 1 month
Intensity of Chest Pain Episodes Baseline	1.33 units on a scale Standard Deviation 0.82	0.6 units on a scale Standard Deviation 0.89
Intensity of Chest Pain Episodes 1 Month	0.67 units on a scale Standard Deviation 1.03	0.8 units on a scale Standard Deviation 0.84

SECONDARY outcome

Timeframe: Baseline and 1 month

This is determined by the Esophageal Balloon Distension Test; range 0-65 mmHg

Outcome measures

Outcome measures
Measure	Marinol n=6 Participants Marinol: 5mg BID, orally for 1 month	Placebo n=6 Participants Placebo: 5mg BID, orally for 1 month
Sensory Thresholds for First Sensation	2 mmHg Standard Deviation .125	2.7 mmHg Standard Deviation .103

SECONDARY outcome

Timeframe: Baseline vs 1 month

Population: 1 participant in placebo did not have this information completed

0 - is none and 3 is longer than 30 mins; higher values is worst outcome; chest pain totals are averaged

Outcome measures

Outcome measures
Measure	Marinol n=6 Participants Marinol: 5mg BID, orally for 1 month	Placebo n=5 Participants Placebo: 5mg BID, orally for 1 month
Duration of Chest Pain Episodes 1 Month	1.2 units on a scale Standard Deviation 1.64	1 units on a scale Standard Deviation 1
Duration of Chest Pain Episodes Baseline	1.83 units on a scale Standard Deviation 1.17	1 units on a scale Standard Deviation 1.55

SECONDARY outcome

Timeframe: Baseline and 1 month

Population: 1 participant in marinol and 1 participant in placebo did not have this information completed

When participants felt pain at earliest pressure; range 0-65 mmHg

Outcome measures

Outcome measures
Measure	Marinol n=5 Participants Marinol: 5mg BID, orally for 1 month	Placebo n=5 Participants Placebo: 5mg BID, orally for 1 month
Sensory Thresholds for Discomfort Baseline	6 mmHg Standard Deviation 5.48	5 mmHg Standard Deviation 5
Sensory Thresholds for Discomfort 1 Month	8 mmHg Standard Deviation 13.04	2 mmHg Standard Deviation 4.47

SECONDARY outcome

Timeframe: Baseline and 1 month

Population: 1 participant in marinol and 1 participant in placebo did not have this information completed

When highest amount of pain was felt; range is 0-65 mmHg

Outcome measures

Outcome measures
Measure	Marinol n=5 Participants Marinol: 5mg BID, orally for 1 month	Placebo n=5 Participants Placebo: 5mg BID, orally for 1 month
Sensory Thresholds for Pain Baseline	42 mmHg Standard Deviation 16.81	53 mmHg Standard Deviation 9.75
Sensory Thresholds for Pain 1 Month	47 mmHg Standard Deviation 16.8	51 mmHg Standard Deviation 15.17

Adverse Events

Marinol

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Marinol n=7 participants at risk Marinol: 5mg BID, orally for 1 month	Placebo n=6 participants at risk Placebo: 5mg BID, orally for 1 month
Gastrointestinal disorders Viral Gastroenteritis	14.3% 1/7 • Number of events 1	16.7% 1/6 • Number of events 1

Additional Information

Dr. Ron Schey

Temple University

Phone: 215-707-9900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place