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A Study of Cannabis Based Medicine Extracts and Placebo in Patients With Pain Due to Spinal Cord Injury

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
Sponsor:
Information provided by (Responsible Party):
Jazz Pharmaceuticals

Study Type Interventional
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title GW-1000-02 Placebo
Hide Arm/Group Description 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
Arm/Group Title GW-1000-02 Placebo Total
Hide Arm/Group Description Active treatment. Placebo control. Total of all reporting groups
Overall Number of Baseline Participants 56 60 116
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 60 participants 116 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
51
  91.1%
55
  91.7%
106
  91.4%
>=65 years
5
   8.9%
5
   8.3%
10
   8.6%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
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
Number Analyzed 56 participants 60 participants 116 participants
Female
13
  23.2%
12
  20.0%
25
  21.6%
Male
43
  76.8%
48
  80.0%
91
  78.4%
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
1.Primary Outcome
Title Change From Baseline in Mean Central Neuropathic Pain 11-Point Numerical Rating Scale Scores at the End of Treatment (up to 51 Days).
Hide Description The Central Neuropathic Pain Numerical Rating Scale score was recorded three times daily, in the morning (on waking), at lunchtime and in the evening using the scale, 0 = 'No Pain' and 10 = 'Worst Possible Pain'. Patients were instructed to relate 'No Pain' to the time before the start of their spinal cord injury. End of Treatment was defined as the mean of the last seven days in the study or the mean of the last three days if the subject withdrew. A negative value indicates an improvement in pain score from baseline.
Time Frame Up to 51 days
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.
Arm/Group Title GW-1000-02 Placebo
Hide Arm/Group Description:
Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Overall Number of Participants Analyzed 55 59
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.74  (1.12) -0.69  (1.39)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GW-1000-02, Placebo
Comments The change in the pain Numerical Rating Scale score from baseline to End of Treatment was compared between treatment groups using analysis of covariance (ANCOVA). The model included treatment and centre as factors and baseline Numerical Rating Scale pain mean score as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.708
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -0.08
Confidence Interval (2-Sided) 95%
-0.51 to 0.35
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in the Mean Percentage of Days on Which Escape Medication Was Used at the End of Treatment
Hide Description The percentage of days that subjects used escape medication was analysed and is presented as the mean change from baseline at the end of treatment. A negative value from baseline indicates an improvement.
Time Frame Up to 51 days
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.
Arm/Group Title GW-1000-02 Placebo
Hide Arm/Group Description:
Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Overall Number of Participants Analyzed 55 59
Mean (Standard Deviation)
Unit of Measure: percentage of days
-4.68  (18.25) -2.91  (20.83)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GW-1000-02, Placebo
Comments The change from baseline to End of Treatment in the percentage of days on which escape medication was used was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and percentage of days on which escape medication was used as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.852
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -0.57
Confidence Interval (2-Sided) 95%
-6.62 to 5.48
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Mean Spasm Severity Numerical Rating Scale Score at the End of Treatment
Hide Description Each day, just before going to bed, patients recorded in their patient diary whether they experienced any spasms that day and, if yes, recorded the overall level of the spasm(s) experienced using an Numerical Rating Scale spasm scale ranging from 0 = "Mildest ever spasm" to 10 = "Worst ever spasm". The mean spasm severity scores were summarised and analysed analogously to the primary endpoint. A negative value from baseline indicates an improvement.
Time Frame Up to 51 days
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.
Arm/Group Title GW-1000-02 Placebo
Hide Arm/Group Description:
Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Overall Number of Participants Analyzed 42 48
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.50  (1.46) -0.69  (1.59)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GW-1000-02, Placebo
Comments The change from baseline to End of Treatment in the Spasm severity Numerical Rating Scale score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the Spasm severity Numerical Rating Scale score as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.860
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value 0.05
Confidence Interval (2-Sided) 95%
-0.54 to 0.65
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in the Percentage of Days on Which Spasm Was Experienced at the End of Treatment
Hide Description Each day, just before going to bed, patients recorded in their patient diary whether they experienced any spasms that day. The percentage of days on which spasm was experienced were summarised and analysed analogously to the primary endpoint. A negative value from baseline indicates an improvement.
Time Frame Up to 51 days
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.
Arm/Group Title GW-1000-02 Placebo
Hide Arm/Group Description:
Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Overall Number of Participants Analyzed 52 59
Mean (Standard Deviation)
Unit of Measure: percentage of days
-1.92  (20.01) -1.57  (22.62)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GW-1000-02, Placebo
Comments The change from baseline to End of Treatment in the percentage of days on which spasm was experienced was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the Spasm percentage of days on which spasm was experienced as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.873
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -0.64
Confidence Interval (2-Sided) 95%
-8.56 to 7.27
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Mean Spasticity Severity Numerical Rating Scale Scores the End of Treatment.
Hide Description Each day at bed time patients recorded whether they experienced any spasticity that day and, if yes, the overall level of spasticity experienced was quantified using an Numerical Rating Scale from 0 = "Mildest ever spasticity" to 10 = "Worst ever spasticity". The mean spasticity severity scores and the changes from baseline to End of Treatment were to be calculated. A negative value indicates an improvement from baseline.
Time Frame 0 - 51 days
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.
Arm/Group Title GW-1000-02 Placebo
Hide Arm/Group Description:
Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Overall Number of Participants Analyzed 35 43
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.37  (1.25) -0.46  (1.80)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GW-1000-02, Placebo
Comments The change from baseline to End of Treatment in the spasticity severity Numerical Rating Scale score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the baseline spasticity severity Numerical Rating Scale score as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.830
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value 0.07
Confidence Interval (2-Sided) 95%
-0.61 to 0.75
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in the Percentage of Days on Which Spasticity Was Experienced at the End of Treatment
Hide Description Each day, just before going to bed, patients recorded in their patient diary whether they had experienced any spasticity that day or not. The percentage of days on which spasticity was experienced (spasticity incidence) was calculated and summarised analogously to the primary efficacy parameter of Numerical Rating Scale pain score. A negative value from baseline indicates an improvement.
Time Frame Up to 51 days
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.
Arm/Group Title GW-1000-02 Placebo
Hide Arm/Group Description:
Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Overall Number of Participants Analyzed 50 59
Mean (Standard Deviation)
Unit of Measure: percentage of days
0.86  (6.71) 0.48  (14.76)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GW-1000-02, Placebo
Comments The change from baseline to End of Treatment in the percentage of days on which spasticity was experienced was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the percentage of days on which spasticity was experienced as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.860
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value 0.40
Confidence Interval (2-Sided) 95%
-4.08 to 4.88
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Modified Ashworth Scale Score at the End of Treatment
Hide Description The Modified Ashworth Scale is a five-point scale conducted on four pre-identified muscle groups. Only the lower limb was assessed because not all Spinal Cord Injury patients upper limb disability. The assessor used the Modified Ashworth scale ranging from 0 ("No increase in muscle tone") to 4 ("Affected part(s) rigid in flexion or extension") to rate the muscle tone for knee and ankle for the left and right sides separately at a pre-dose visit and at the end of treatment. The average of the four individual scores and was taken. A negative value indicates an improvement from baseline.
Time Frame Up to 51 days
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.
Arm/Group Title GW-1000-02 Placebo
Hide Arm/Group Description:
Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Overall Number of Participants Analyzed 40 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.13  (0.43) -0.01  (0.42)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GW-1000-02, Placebo
Comments The change from baseline to End of Treatment in the Modified Ashworth scale score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the Modified Ashworth scale score as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.142
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -0.14
Confidence Interval (2-Sided) 95%
-0.33 to 0.05
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in the Mean Short Orientation Memory Function Concentration Test Score at the End of Treatment
Hide Description

Patients were asked at baseline and end of treatment, to complete the Short Orientation Memory Function Concentration Test as a measure of cognitive function. The minimum score is 0 and maximum of 28 which denoted good cognitive function .

A negative value from baseline indicates a deterioration.
Time Frame Up to 51 days
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis.
Arm/Group Title GW-1000-02 Placebo
Hide Arm/Group Description:
Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Overall Number of Participants Analyzed 55 58
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.4  (2.79) 0.2  (2.98)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GW-1000-02, Placebo
Comments The change from baseline in the mean Short Orientation Memory Concentration score, was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline Short Orientation Memory Concentration test score as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.824
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -0.11
Confidence Interval (2-Sided) 95%
-1.13 to 0.90
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline in Mean Spitzer Quality of Life Index Score at the End of Treatment
Hide Description The Spitzer Quality of Life Index questionnaire consists of five sections, relating to activity, daily living, health, support and outlook. Each section has three choices (numbered 1, 2 and 3) and the patient is required to choose the one that best describes their quality of life during the last week. Choice 1 is scored 2, choice 2 is scored 1 and choice 3 is scored 0. The total Spitzer is the unweighted sum of the five scores. The scale is 0 (bad) to 10 (good). A positive value indicates an improvement from baseline.
Time Frame Up to 51 days
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis.
Arm/Group Title GW-1000-02 Placebo
Hide Arm/Group Description:
Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Overall Number of Participants Analyzed 55 58
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.1  (1.41) 0.1  (1.30)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GW-1000-02, Placebo
Comments The change from baseline to End of Treatment in the Spitzer Quality of Life Index score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the Spitzer Quality of Life Index score as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.847
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -0.04
Confidence Interval (2-Sided) 95%
-0.49 to 0.40
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change From Baseline in the Mean Caregiver Strain Index Score at the End of Treatment
Hide Description Carers were asked at baseline and end of treatment to complete the Caregiver Strain Index, as a measure of the strain they felt from being a carer, the maximum possible score being 13. A negative value from baseline indicates an improvement.
Time Frame Up to 51 days
Hide Outcome Measure Data
Hide Analysis Population Description
All caregivers of patients in the current study who responded to the caregiver strain index questionnaire were included in the analysis.
Arm/Group Title GW-1000-02 Placebo
Hide Arm/Group Description:
Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Overall Number of Participants Analyzed 12 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.3  (2.73) 1.2  (3.45)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GW-1000-02, Placebo
Comments The change from baseline to End of Treatment in the Caregiver Strain Index score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and the baseline Caregiver Strain Index score as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.287
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -1.29
Confidence Interval (2-Sided) 95%
-3.74 to 1.16
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Number of Subjects Who Reported an Improvement in Their Overall Condition in the Patient Global Impression of Change at the End of Treatment
Hide Description The Patient Global Impression of Change asked patients to give their impression of the overall change in their condition during the study at the end of treatment using the following scale: 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, 7 = Very Much Worse. The number of patients who scored their condition as 1, 2, or 3 (improved) is presented.
Time Frame Up to 51 days
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the analysis.
Arm/Group Title GW-1000-02 Placebo
Hide Arm/Group Description:
Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Overall Number of Participants Analyzed 56 60
Measure Type: Number
Unit of Measure: participants
30 12
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GW-1000-02, Placebo
Comments The proportion of subjects who considered their condition 'Very Much Improved', 'Much Improved' or 'Minimally Improved' was compared between treatment groups using Fisher's Exact Test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value 33.86
Confidence Interval (2-Sided) 95%
17.07 to 50.64
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline in the Mean Brief Pain Inventory Score at the End of Treatment
Hide Description The Brief Pain Inventory is a 14-item questionnaire that asks patients to rate pain over the prior week and the degree to which it interferes with activities on a 0 to 10 scale, where 0=no pain and 10=pain as bad as you can imagine. Severity is measured as worst pain, least pain, average pain, and pain right now. The severity composite score is calculated as the arithmetic mean of the four severity items(range 0-10). A negative value indicates an improvement in worst pain score from baseline.
Time Frame 0 - 51 days
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.
Arm/Group Title GW-1000-02 Placebo
Hide Arm/Group Description:
Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Overall Number of Participants Analyzed 53 57
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.1  (5.22) -1.2  (4.64)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GW-1000-02, Placebo
Comments The change from baseline to End of Treatment in the Brief Pain Inventory score was compared between treatment groups using ANCOVA. The model included treatment and centre as factors and baseline Brief Pain Inventory score as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.032
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -1.93
Confidence Interval (2-Sided) 95%
-3.69 to -0.16
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in the Mean Sleep Disturbance Numerical Rating Scale Score at the End of Treatment
Hide Description Each day patients recorded in their patient diary whether they woke during the previous night using the following scoring system: 0 = No, 1 = Once, 2 = Twice, 3 = More than twice, 4 = Awake most of the night. A negative value indicates an improvement from baseline.
Time Frame 0 - 51 days
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised patients who received at least one dose of test treatment and have on-treatment efficacy data were included in the analysis.
Arm/Group Title GW-1000-02 Placebo
Hide Arm/Group Description:
Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Overall Number of Participants Analyzed 55 59
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.41  (0.59) -0.38  (0.73)
14.Secondary Outcome
Title Incidence of Adverse Events as a Measure of Patient Safety.
Hide Description The number of patients who experienced an adverse event during the study is presented.
Time Frame Up to 61 days
Hide Outcome Measure Data
Hide Analysis Population Description
All randomised patients who received at least one dose of study drug were included in the Safety population.
Arm/Group Title GW-1000-02 Placebo
Hide Arm/Group Description:
Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Overall Number of Participants Analyzed 56 60
Measure Type: Number
Unit of Measure: participants
46 29
Time Frame All adverse events occurring from the time of consent to post study follow up (0-61 days) were collected. All deaths and serious adverse events occurring within 28 days of the final dose of study medication were also collected.
Adverse Event Reporting Description All adverse events occurring during the study were reported on the running logs at the back of the study case report form.
 
Arm/Group Title GW-1000-02 Placebo
Hide Arm/Group Description Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours. Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
All-Cause Mortality
GW-1000-02 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
GW-1000-02 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   3/56 (5.36%)   2/60 (3.33%) 
Blood and lymphatic system disorders     
Anaemia Not Otherwise Specified Aggravated † 1  1/56 (1.79%)  0/60 (0.00%) 
General disorders     
Fall † 1  1/56 (1.79%)  1/60 (1.67%) 
Infections and infestations     
Methicillin-resistant Staphylococcus aureus infection † 1  1/56 (1.79%)  0/60 (0.00%) 
Bladder Infection Not Otherwise Specified † 1  0/56 (0.00%)  1/60 (1.67%) 
Pneumonia Not Otherwise Specified † 1  0/56 (0.00%)  1/60 (1.67%) 
Injury, poisoning and procedural complications     
Tibia Fracture † 1  1/56 (1.79%)  0/60 (0.00%) 
Upper Limb Fracture Not Otherwise Specified † 1  0/56 (0.00%)  1/60 (1.67%) 
Nervous system disorders     
Dizziness † 1  0/56 (0.00%)  1/60 (1.67%) 
Psychiatric disorders     
Confusion † 1  1/56 (1.79%)  0/60 (0.00%) 
Paranoia † 1  1/56 (1.79%)  0/60 (0.00%) 
Skin and subcutaneous tissue disorders     
Contusion † 1  0/56 (0.00%)  1/60 (1.67%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 5.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
GW-1000-02 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   46/56 (82.14%)   29/60 (48.33%) 
Eye disorders     
Vision Blurred † 1  2/56 (3.57%)  0/60 (0.00%) 
Gastrointestinal disorders     
Nausea † 1  6/56 (10.71%)  3/60 (5.00%) 
Constipation † 1  4/56 (7.14%)  0/60 (0.00%) 
Dry Mouth † 1  4/56 (7.14%)  0/60 (0.00%) 
Oral Pain † 1  2/56 (3.57%)  3/60 (5.00%) 
Oral Discomfort † 1  2/56 (3.57%)  0/60 (0.00%) 
Vomiting Not Otherwise Specified † 1  2/56 (3.57%)  0/60 (0.00%) 
General disorders     
Lethargy † 1  4/56 (7.14%)  0/60 (0.00%) 
Feeling Abnormal † 1  3/56 (5.36%)  0/60 (0.00%) 
Feeling Drunk † 1  3/56 (5.36%)  0/60 (0.00%) 
Application Site Pain † 1  2/56 (3.57%)  0/60 (0.00%) 
Fatigue † 1  2/56 (3.57%)  0/60 (0.00%) 
Pain Exacerbated † 1  2/56 (3.57%)  0/60 (0.00%) 
Fall † 1  0/56 (0.00%)  2/60 (3.33%) 
Feeling of Relaxation † 1  0/56 (0.00%)  2/60 (3.33%) 
Pyrexia † 1  0/56 (0.00%)  2/60 (3.33%) 
Infections and infestations     
Urinary Tract Infection Not Otherwise Specified † 1  8/56 (14.29%)  4/60 (6.67%) 
Investigations     
Alanine Aminotransferase Increased † 1  2/56 (3.57%)  3/60 (5.00%) 
Gamma-Glutamyltransferase Increased † 1  2/56 (3.57%)  3/60 (5.00%) 
Blood Bilirubin Increased † 1  2/56 (3.57%)  0/60 (0.00%) 
Blood Sodium Decreased † 1  2/56 (3.57%)  0/60 (0.00%) 
Haematocrit Decreased † 1  2/56 (3.57%)  0/60 (0.00%) 
Haemoglobin Decreased † 1  2/56 (3.57%)  0/60 (0.00%) 
Red Blood Cell Count Decreased † 1  2/56 (3.57%)  0/60 (0.00%) 
White Blood Cell Count Increased † 1  2/56 (3.57%)  0/60 (0.00%) 
Neutrophil Count Increased † 1  0/56 (0.00%)  2/60 (3.33%) 
Musculoskeletal and connective tissue disorders     
Muscle Spasms † 1  0/56 (0.00%)  2/60 (3.33%) 
Nervous system disorders     
Dizziness † 1  14/56 (25.00%)  5/60 (8.33%) 
Dysgeusia † 1  9/56 (16.07%)  4/60 (6.67%) 
Somnolence † 1  7/56 (12.50%)  0/60 (0.00%) 
Headache Not Otherwise Specified † 1  5/56 (8.93%)  0/60 (0.00%) 
Disturbance in Attention † 1  3/56 (5.36%)  0/60 (0.00%) 
Speech Disorder † 1  2/56 (3.57%)  0/60 (0.00%) 
Paraesthesia † 1  0/56 (0.00%)  2/60 (3.33%) 
Psychiatric disorders     
Confusion † 1  2/56 (3.57%)  0/60 (0.00%) 
Insomnia † 1  0/56 (0.00%)  2/60 (3.33%) 
Vascular disorders     
Flushing † 1  2/56 (3.57%)  0/60 (0.00%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 5.0
[Not Specified]
Certain Agreements
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
Layout table for Results Point of Contact information
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):
Layout table for additonal information
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