A Study of Cannabis Based Medicine Extracts and Placebo in Patients With Pain Due to Spinal Cord Injury
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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. |
ClinicalTrials.gov Identifier: NCT01606202 |
Recruitment Status :
Completed
First Posted : May 25, 2012
Results First Posted : September 28, 2012
Last Update Posted : September 28, 2012
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Sponsor:
Jazz Pharmaceuticals
Information provided by (Responsible Party):
Jazz Pharmaceuticals
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Pain |
Interventions |
Drug: GW-1000-02 Drug: Placebo |
Enrollment | 116 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | GW-1000-02 | Placebo |
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Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). The maximum permitted dose of was eight actuations in any three hour period, and 48 actuations in any 24 hour period (THC 130 mg : CBD 120 mg). | Placebo control.The maximum permitted dose of was eight actuations in any three hour period, and 48 actuations in any 24 hour period. |
Period Title: Overall Study | ||
Started | 56 | 60 |
Completed | 49 | 57 |
Not Completed | 7 | 3 |
Reason Not Completed | ||
Adverse Event | 5 | 0 |
Withdrawal by Subject | 2 | 1 |
Personal problems | 0 | 1 |
Problems with administration | 0 | 1 |
Baseline Characteristics
Arm/Group Title | GW-1000-02 | Placebo | Total | |
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Active treatment. | Placebo control. | Total of all reporting groups | |
Overall Number of Baseline Participants | 56 | 60 | 116 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 56 participants | 60 participants | 116 participants | |
<=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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Between 18 and 65 years |
51 91.1%
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55 91.7%
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106 91.4%
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>=65 years |
5 8.9%
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5 8.3%
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10 8.6%
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 56 participants | 60 participants | 116 participants | |
48.7 (12.97) | 47.6 (12.69) | 48.1 (12.69) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 56 participants | 60 participants | 116 participants | |
Female |
13 23.2%
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12 20.0%
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25 21.6%
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Male |
43 76.8%
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48 80.0%
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91 78.4%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 56 participants | 60 participants | 116 participants |
United Kingdom | 49 | 51 | 100 | |
Romania | 7 | 9 | 16 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
GW will coordinate the dissemination of data from this study and may solicit input and assistance from the principal investigator. All publications, for example manuscripts, abstracts, oral/slide presentations or book chapters based on this study, must be submitted to GW for corporate review before release.
Results Point of Contact
Name/Title: | Mr Richard Potts, Clinical Operations Director |
Organization: | GW Pharma Ltd. |
Phone: | 0044 1223 266800 |
EMail: | rp@gwpharm.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Jazz Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT01606202 |
Other Study ID Numbers: |
GWSC0101 |
First Submitted: | May 21, 2012 |
First Posted: | May 25, 2012 |
Results First Submitted: | July 19, 2012 |
Results First Posted: | September 28, 2012 |
Last Update Posted: | September 28, 2012 |