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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yehudith Assouline-Dayan, University of Iowa
ClinicalTrials.gov Identifier:
NCT01598207
First received: May 10, 2012
Last updated: April 26, 2017
Last verified: April 2017
Results First Received: March 21, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Investigator;   Primary Purpose: Treatment
Condition: Chest Pain
Interventions: Drug: Marinol
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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
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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.
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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
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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
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  More Information
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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
Study First Received: May 10, 2012
Results First Received: March 21, 2016
Last Updated: April 26, 2017