We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01598207
First Posted: May 15, 2012
Last Update Posted: April 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yehudith Assouline-Dayan, University of Iowa
Results First Submitted: March 21, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Chest Pain
Interventions: Drug: Marinol
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Marinol Marinol: 5mg BID, orally for 1 month
Placebo Placebo: 5mg BID, orally for 1 month

Participant Flow:   Overall Study
    Marinol   Placebo
STARTED   7   6 
COMPLETED   6   6 
NOT COMPLETED   1   0 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Marinol Marinol: 5mg BID, orally for 1 month
Placebo Placebo: 5mg BID, orally for 1 month
Total Total of all reporting groups

Baseline Measures
   Marinol   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   6   13 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      7 100.0%      6 100.0%      13 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      6  85.7%      4  66.7%      10  76.9% 
Male      1  14.3%      2  33.3%      3  23.1% 
Region of Enrollment 
[Units: Participants]
     
United States   7   6   13 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Frequency of Chest Pain Episodes   [ Time Frame: Baseline and 1 month ]

2.  Secondary:   Frequency of Chest Pain in Treatment Group vs Baseline   [ Time Frame: 1 month ]

3.  Secondary:   Intensity of Chest Pain Episodes   [ Time Frame: Baseline and 1 month ]

4.  Secondary:   Sensory Thresholds for First Sensation   [ Time Frame: Baseline and 1 month ]

5.  Secondary:   Duration of Chest Pain Episodes   [ Time Frame: Baseline vs 1 month ]

6.  Secondary:   Sensory Thresholds for Discomfort   [ Time Frame: Baseline and 1 month ]

7.  Secondary:   Sensory Thresholds for Pain   [ Time Frame: Baseline and 1 month ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Ron Schey
Organization: Temple University
phone: 215-707-9900
e-mail: Ron.schey@tuhs.temple.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Yehudith Assouline-Dayan, University of Iowa
ClinicalTrials.gov Identifier: NCT01598207     History of Changes
Other Study ID Numbers: 201003768
First Submitted: May 10, 2012
First Posted: May 15, 2012
Results First Submitted: March 21, 2016
Results First Posted: April 28, 2017
Last Update Posted: April 28, 2017