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A Study to Compare Sublingual Cannabis Based Medicine Extracts With Placebo to Treat Brachial Plexus Injury Pain

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: NCT01606189
Recruitment Status : Completed
First Posted : May 25, 2012
Results First Posted : November 19, 2012
Last Update Posted : March 17, 2014
Sponsor:
Information provided by (Responsible Party):
GW Pharmaceuticals Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pain
Interventions Drug: GW-1000-02
Drug: GW-2000-02
Drug: Placebo
Enrollment 48
Recruitment Details  
Pre-assignment Details  
Arm/Group Title GW-1000-02 First, Then GW-2000-02, Then Placebo GW-2000-02 First, Then GW-1000-02, Then Placebo Placebo First, Then GW-1000-02, Then GW-2000-02 GW-1000-02 First, Then Placebo, Then GW-2000-02 Placebo First, Then GW-2000-02, Then GW-1000-02 GW-2000-02 First, Then Placebo, Then GW-1000-02
Hide Arm/Group Description

GW-1000-02 first (14-20 days), then GW-2000-02 (14-20 days), then placebo (14-20 days).

Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period).

GW-2000-02 first (14-20 days), then GW-1000-02 (14-20 days), then placebo (14-20 days).

Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period).

Placebo first (14-20 days), then GW-1000-02 (14-20 days), then GW-2000-02 (14-20 days).

Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period).

GW-1000-02 first (14-20 days), then placebo (14-20 days), then GW-2000-02 (14-20 days).

Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period).

Placebo first (14-20 days), then GW-1000-02 (14-20 days), then GW-2000-02 (14-20 days).

Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period).

GW-2000-02 first (14-20 days), then GW-1000-02 (14-20 days), then placebo (14-20 days).

Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period).

Period Title: First Intenvention (14-20 Days)
Started 8 8 8 8 8 8
Completed 8 8 8 8 8 8
Not Completed 0 0 0 0 0 0
Period Title: Second Intenvention (14-20 Days)
Started 8 8 8 8 8 8
Completed 8 8 8 8 8 7
Not Completed 0 0 0 0 0 1
Reason Not Completed
Adverse Event             0             0             0             0             0             1
Period Title: Third Intenvention (14-20 Days)
Started 8 8 8 8 8 7
Completed 8 8 8 8 8 6
Not Completed 0 0 0 0 0 1
Reason Not Completed
Withdrawal by Subject             0             0             0             0             0             1
Arm/Group Title All Study Treatments: GW-1000-02, GW-2000-02 and Placebo
Hide Arm/Group Description As this was a crossover study design, all patients were to receive all study treatments: GW-1000-02, GW-2000-02 and placebo.
Overall Number of Baseline Participants 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
<=18 years
0
   0.0%
Between 18 and 65 years
48
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 48 participants
38.53  (10.342)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
Female
2
   4.2%
Male
46
  95.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 48 participants
48
1.Primary Outcome
Title Change From Baseline in the Mean Box Scale-11 Pain Review Score at the End of Each Treatment Period (Each Lasting 14-20 Days)
Hide Description Each day patients recorded in their patient diary, the severity of their pain during the previous 24 hours using a Box Scale-11 pain score ranging from zero “no pain at all” to 10 “pain as bad as you can imagine”. The Box Scale-11 pain score endpoint for each assessment period was the average of all available data recorded during the seven whole days prior to the visit immediately subsequent to that period, but only including data from Day 8 onwards. A negative value indicates an improvement in pain score from baseline.
Time Frame Up to 74 days
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.
Arm/Group Title GW-1000-02 GW-2000-02 Placebo
Hide Arm/Group Description:
Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Overall Number of Participants Analyzed 45 47 47
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.6  (1.13) -0.6  (1.34) 0.0  (1.23)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GW-1000-02, Placebo
Comments Box Scale-11 pain scores were compared between treatment groups using an analysis of variance (ANOVA). The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Box Scale-11 Pain Score = Patient + Treatment + Period
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -0.58
Confidence Interval (2-Sided) 95%
-0.98 to -0.18
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GW-2000-02, Placebo
Comments Box Scale-11 pain scores were compared between treatment groups using an ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Box Scale-11 Pain Score = Patient + Treatment + Period
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -0.64
Confidence Interval (2-Sided) 95%
-1.03 to -0.24
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in the Mean Sleep Disturbance Score at the End of Each Treatment Period (Each Lasting 14-20 Days).
Hide Description Each day patients recorded in their patient diary the number of times they were woken due to pain during the previous night. The results were recorded as “None”, “Once”, “Twice” and “More Than Twice” and converted to a four point scale, zero to three respectively. The treatment days and the assessment periods were defined in the same way as for the Box Scale-11 pain score. A negative value indicates an improvement from baseline.
Time Frame Up to 74 days
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.
Arm/Group Title GW-1000-02 GW-2000-02 Placebo
Hide Arm/Group Description:
Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Overall Number of Participants Analyzed 44 46 46
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.2  (0.43) -0.4  (0.51) 0.0  (0.47)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GW-1000-02, Placebo
Comments Sleep disturbance scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Sleep disturbance Score = Patient + Treatment + Period
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -0.20
Confidence Interval (2-Sided) 95%
-0.37 to -0.04
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GW-2000-02, Placebo
Comments Sleep disturbance scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Sleep disturbance Score = Patient + Treatment + Period
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -0.33
Confidence Interval (2-Sided) 95%
-0.49 to -0.16
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in the Mean Box Scale-11 Sleep Quality Score at the End of Each Treatment Period (Each Lasting 14-20 Days).
Hide Description Each day patients recorded in their patient diary the quality of their sleep during the previous night using a Box Scale-11 sleep score ranging from zero “Worst Imaginable” to 10 “Best Imaginable”. The treatment days and the assessment periods were defined in the same way as for the Box Scale-11 pain score. A positive value indicates an improvement from baseline.
Time Frame Up to 74 days
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.
Arm/Group Title GW-1000-02 GW-2000-02 Placebo
Hide Arm/Group Description:
Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Overall Number of Participants Analyzed 45 47 47
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.9  (1.22) 1.2  (1.39) 0.4  (1.40)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GW-1000-02, Placebo
Comments Sleep quality scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Sleep Quality Score = Patient + Treatment + Period
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.019
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value 0.55
Confidence Interval (2-Sided) 95%
0.09 to 1.01
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GW-2000-02, Placebo
Comments Sleep quality scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Sleep Quality Score = Patient + Treatment + Period
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value 0.79
Confidence Interval (2-Sided) 95%
0.33 to 1.24
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in the Mean McGill Pain Questionnaire Part 1 Score for 'Total Pain Intensity' at the End of Each Treatment Period (Each Lasting 14-20 Days)
Hide Description Part 1 of the questionnaire related to the intensity of 15 different types of pain. Intensity was recorded separately for each type of pain on a zero to three scale, where zero = “None”, one = “Mild”, two = “Moderate” and three = “Severe”. The total intensity was defined as the unweighted sum of the 15 scores, giving a minimum possible score of zero (lowest pain score) and a maximum possible score of 45 (highest pain score). The distribution of each of the 15 types of pain was summarised at baseline and for each treatment. A negative value indicates an improvement in pain from baseline.
Time Frame Up to 74 days
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.
Arm/Group Title GW-1000-02 GW-2000-02 Placebo
Hide Arm/Group Description:
Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Overall Number of Participants Analyzed 46 46 48
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.2  (8.91) -3.8  (9.37) -1.8  (9.26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GW-1000-02, Placebo
Comments Total pain intensity scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Total Pain Intensity Score = Patient + Treatment + Period
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.146
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -1.55
Confidence Interval (2-Sided) 95%
-3.64 to 0.55
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GW-2000-02, Placebo
Comments Total pain intensity scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Total Pain Intensity Score = Patient + Treatment + Period
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.040
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -2.20
Confidence Interval (2-Sided) 95%
-4.29 to -0.10
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in the Mean McGill Pain Questionnaire Part 2 Score for 'Intensity of Pain' at the End of Each Treatment Period (Each Lasting 14-20 Days)
Hide Description Part 2 of the questionnaire recorded the intensity of pain at present. Results were recorded on a VAS ranging from zero “No pain” to 100 “Worst possible pain”. Intensity of pain was summarised and analysed in the same manner as the primary efficacy parameter of Box Scale-11 pain score. A negative value indicates an improvement from baseline.
Time Frame Up to 74 days
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.
Arm/Group Title GW-1000-02 GW-2000-02 Placebo
Hide Arm/Group Description:
Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Overall Number of Participants Analyzed 46 47 48
Mean (Standard Deviation)
Unit of Measure: units on a scale
-14.9  (25.15) -17.3  (26.74) -8.0  (26.92)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GW-1000-02, Placebo
Comments Intensity of Pain scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Intensity of Pain Score = Patient + Treatment + Period
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.092
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -7.28
Confidence Interval (2-Sided) 95%
-15.78 to 1.21
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GW-2000-02, Placebo
Comments Intensity of Pain scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Intensity of Pain Score = Patient + Treatment + Period
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.037
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -8.99
Confidence Interval (2-Sided) 95%
-17.41 to -0.57
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in the Number of Patients Who Reported 'No Pain' or 'Mild Pain' Using a McGill Pain Questionnaire Part 3 Score for 'Strength of Pain at Present' at the End of Each Treatment Period (Each Lasting 14-20 Days)
Hide Description Part 3 of the questionnaire recorded the strength of pain at present. Results were recorded in six categories which were classified as “No Pain”, “Mild”, “Discomforting”, “Distressing”, “Horrible” and “Excruciating”. The change from baseline in the number of patients who reported “No Pain” or “Mild Pain” at the end of the respective treatment periods is presented. An increase in number indicates an improvement from baseline.
Time Frame Up to 74 days
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.
Arm/Group Title GW-1000-02 GW-2000-02 Placebo
Hide Arm/Group Description:
Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Overall Number of Participants Analyzed 46 47 48
Measure Type: Number
Unit of Measure: participants
4 4 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GW-1000-02, Placebo
Comments Pain at present was analysed using the Mann-Whitney test with a correction for ties. Results were presented in terms of the sums of the ranks for the two groups, the Mann-Whitney U statistic and the associated p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.328
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mann-Whitney U statistic
Estimated Value 1222.0
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GW-2000-02, Placebo
Comments Pain at present was analysed using the Mann-Whitney test with a correction for ties. Results were presented in terms of the sums of the ranks for the two groups, the Mann-Whitney U statistic and the associated p-value.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.560
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mann-Whitney U statistic
Estimated Value 1200.5
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in the Mean Pain Disability Index Score at the End of Each Treatment Period (Each Lasting 14-20 Days).
Hide Description The Pain Disability Index consisted of seven assessments representing different aspects of disability due to pain. Each assessment was scored on a zero to 10 scale, where zero equated with “no disability” and 10 equated with “total disability”. The total Pain Disability Index score was the unweighted sum of the seven pain scores, ranging from zero to 70. A negative value indicates an improvement from baseline.
Time Frame Up to 74 days
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.
Arm/Group Title GW-1000-02 GW-2000-02 Placebo
Hide Arm/Group Description:
Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Overall Number of Participants Analyzed 46 47 48
Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.3  (9.97) -3.1  (10.37) -3.6  (7.69)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GW-1000-02, Placebo
Comments Pain Disability Index scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Pain Disability Index Score = Patient + Treatment + Period
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.181
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -1.75
Confidence Interval (2-Sided) 95%
-4.32 to 0.83
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GW-2000-02, Placebo
Comments Pain Disability Index scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: Pain Disability Index Score = Patient + Treatment + Period
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.739
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value 0.43
Confidence Interval (2-Sided) 95%
-2.12 to 2.98
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in the Mean 12-Item General Health Questionnaire Score at the End of Each Treatment Period (Each Lasting 14-20 Days).
Hide Description The 12-Item General Health Questionnaire consisted of 12 general health questions. Each question was scored on a zero to three scale, where zero represented the better assessment. The total score was the unweighted sum of the 12 scores, ranging from zero to 36. A negative value indicates an improvement from baseline.
Time Frame Up to 74 days
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.
Arm/Group Title GW-1000-02 GW-2000-02 Placebo
Hide Arm/Group Description:
Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Overall Number of Participants Analyzed 46 47 48
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.2  (6.70) -1.2  (6.12) 0.1  (3.92)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GW-1000-02, Placebo
Comments 12-Item General Health Questionnaire scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: 12-Item General Health Questionnaire Score = Patient + Treatment + Period
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -2.23
Confidence Interval (2-Sided) 95%
-4.01 to -0.45
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GW-2000-02, Placebo
Comments 12-Item General Health Questionnaire scores were compared between treatment groups using ANOVA. The model included factors for patient, treatment and period. The significance of the overall treatment effect was assessed using the F-test from the ANOVA. The model used was as follows: 12-Item General Health Questionnaire Score = Patient + Treatment + Period
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.178
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -1.21
Confidence Interval (2-Sided) 95%
-2.97 to 0.56
Estimation Comments [Not Specified]
9.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 course of study is presented.
Time Frame Up to 114 days
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who entered the study, were randomised and had some on-treatment efficacy data were included in the analysis.
Arm/Group Title GW-1000-02 GW-2000-02 Placebo
Hide Arm/Group Description:
Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
Overall Number of Participants Analyzed 46 47 48
Measure Type: Number
Unit of Measure: participants
34 37 20
Time Frame All adverse events occurring from the study onset to up to 40 days follow-up (up to 114 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 GW-2000-02 Placebo
Hide Arm/Group Description Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours. Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 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 GW-2000-02 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
GW-1000-02 GW-2000-02 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/46 (2.17%)   0/47 (0.00%)   0/48 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  1/46 (2.17%)  0/47 (0.00%)  0/48 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 4.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
GW-1000-02 GW-2000-02 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   34/46 (73.91%)   37/47 (78.72%)   20/48 (41.67%) 
Gastrointestinal disorders       
Nausea  1  0/46 (0.00%)  5/47 (10.64%)  3/48 (6.25%) 
Oral Discomfort  1  0/46 (0.00%)  0/47 (0.00%)  4/48 (8.33%) 
Oral Pain  1  2/46 (4.35%)  2/47 (4.26%)  2/48 (4.17%) 
Dyspepsia  1  0/46 (0.00%)  2/47 (4.26%)  0/48 (0.00%) 
Hypoaesthesia Oral  1  0/46 (0.00%)  0/47 (0.00%)  2/48 (4.17%) 
General disorders       
Feeling Drunk  1  4/46 (8.70%)  4/47 (8.51%)  0/48 (0.00%) 
Lethargy  1  0/46 (0.00%)  3/47 (6.38%)  0/48 (0.00%) 
Pain Exacerbated  1  0/46 (0.00%)  4/47 (8.51%)  0/48 (0.00%) 
Thirst  1  0/46 (0.00%)  3/47 (6.38%)  0/48 (0.00%) 
Fatigue  1  0/46 (0.00%)  0/47 (0.00%)  2/48 (4.17%) 
Metabolism and nutrition disorders       
Appetite Increased  1  2/46 (4.35%)  2/47 (4.26%)  0/48 (0.00%) 
Nervous system disorders       
Dizziness  1  9/46 (19.57%)  11/47 (23.40%)  4/48 (8.33%) 
Somnolence  1  7/46 (15.22%)  6/47 (12.77%)  5/48 (10.42%) 
Dysgeusia  1  10/46 (21.74%)  5/47 (10.64%)  0/48 (0.00%) 
Headache Not Otherwise Specified  1  0/46 (0.00%)  5/47 (10.64%)  0/48 (0.00%) 
Dry Mouth  1  3/46 (6.52%)  3/47 (6.38%)  0/48 (0.00%) 
Dysarthria  1  0/46 (0.00%)  2/47 (4.26%)  0/48 (0.00%) 
Paresthesia Oral  1  0/46 (0.00%)  2/47 (4.26%)  2/48 (4.17%) 
Hypoaesthesia  1  2/46 (4.35%)  0/47 (0.00%)  0/48 (0.00%) 
Psychiatric disorders       
Euphoric Mood  1  3/46 (6.52%)  2/47 (4.26%)  0/48 (0.00%) 
Irritability  1  0/46 (0.00%)  2/47 (4.26%)  0/48 (0.00%) 
Panic Attack  1  0/46 (0.00%)  2/47 (4.26%)  0/48 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Throat Irritation  1  2/46 (4.35%)  4/47 (8.51%)  0/48 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 4.0
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
Name/Title: Mr Richard Potts, Clinical Operations Director
Organization: GW Pharma Ltd.
Phone: 0044 1223 266800
Responsible Party: GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT01606189     History of Changes
Other Study ID Numbers: GWBP0101
First Submitted: May 23, 2012
First Posted: May 25, 2012
Results First Submitted: July 12, 2012
Results First Posted: November 19, 2012
Last Update Posted: March 17, 2014