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A Study of Sativex® for Pain Relief in Patients With Advanced Malignancy (SPRAY)

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: NCT00674609
Recruitment Status : Completed
First Posted : May 8, 2008
Results First Posted : August 13, 2012
Last Update Posted : June 20, 2013
Sponsor:
Information provided by:
GW Pharmaceuticals Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions Palliative Care
Pain
Cancer
Interventions Drug: Placebo
Drug: Sativex®
Drug: THC Alone
Enrollment 177
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sativex THC Alone Placebo
Hide Arm/Group Description Each 100 uL actuation contained 27 mg/ml THC and 25 mg/ml CBD Each 100 uL actuation contained 27 mg/ml THC Each 100 uL actuation contained colourant and excipients
Period Title: Overall Study
Started 60 58 59
Completed 48 45 51
Not Completed 12 13 8
Arm/Group Title Sativex THC Alone Placebo Total
Hide Arm/Group Description Each 100 uL actuation contained 27 mg/ml THC and 25 mg/ml CBD Each 100 uL actuation contained 27 mg/ml THC Each 100 uL actuation contained colourant and excipients Total of all reporting groups
Overall Number of Baseline Participants 60 58 59 177
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 58 participants 59 participants 177 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
39
  65.0%
38
  65.5%
38
  64.4%
115
  65.0%
>=65 years
21
  35.0%
20
  34.5%
21
  35.6%
62
  35.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 58 participants 59 participants 177 participants
59.4  (12.08) 61.3  (12.5) 60.1  (12.31) 60.2  (12.25)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 58 participants 59 participants 177 participants
Female
27
  45.0%
28
  48.3%
27
  45.8%
82
  46.3%
Male
33
  55.0%
30
  51.7%
32
  54.2%
95
  53.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants 58 participants 59 participants 177 participants
United Kingdom 22 18 21 61
Belgium 4 4 3 11
Romania 34 36 35 105
1.Primary Outcome
Title The Change in Mean Pain Numerical Rating Scale (NRS) Score From Baseline to the End of the Treatment.
Hide Description The pain NRS was complete at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours" where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to cancer. A negative value indicates an improvement in pain score from baseline.
Time Frame 2 weeks: baseline - end of week 2 (last 3 days of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population. This population was used for the primary analysis. Presented below is the adjusted mean change from baseline in mean pain NRS.
Arm/Group Title Sativex THC Alone Placebo
Hide Arm/Group Description:
Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
Overall Number of Participants Analyzed 53 52 56
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.32  (1.64) -0.93  (1.15) -0.73  (1.51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The change in mean pain NRS score (average pain) was analyzed using analysis of covariance (ANCOVA) with the baseline value as a covariate and region and treatment group as factors. The null hypothesis was that of no treatment difference.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter estimated mean treatment difference
Estimated Value -0.67
Confidence Interval (2-Sided) 95%
-1.21 to -0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection THC Alone, Placebo
Comments The change in mean pain NRS score (average pain) was analyzed using analysis of covariance (ANCOVA) with the baseline value as a covariate and region and treatment group as factors. The null hypothesis was that of no treatment difference.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.244
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -0.32
Confidence Interval (2-Sided) 95%
-0.86 to 0.22
Estimation Comments [Not Specified]
2.Primary Outcome
Title The Consumption of Escape Analgesic Medication.
Hide Description Subjects recorded their use of escape medication each day on their diary card.
Time Frame 2 weeks: baseline - end of week 2 (last 3 days of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
The primary population for this analysis was the intention-to-treat (ITT) population, which included all randomised subjects who received at least 1 dose of study medication and had on-treatment efficacy data. The primary analysis escape medication usage i.e. the number of days escape medication was used did not include any covariates.
Arm/Group Title Sativex THC Alone Placebo
Hide Arm/Group Description:
Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
Overall Number of Participants Analyzed 54 52 57
Mean (Standard Deviation)
Unit of Measure: tablets per day
0.72  (0.821) 0.88  (0.852) 0.68  (0.662)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The on-treatment data was calculated from all available data during the last three days. The number of days the escape medication was used out of the last three days taken in the study was compared between treatments using logistic regression with a cumulative logit model. From this analysis the frequency distribution (%) of number days escape medication was used was presented together with the odds ratio, p-value and 95% CI for the treatment contrasts.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.688
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter estimated mean treatment difference
Estimated Value -0.04
Confidence Interval (2-Sided) 95%
-0.25 to 0.16
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection THC Alone, Placebo
Comments The on-treatment data was calculated from all available data during the last three days. The number of days the escape medication was used out of the last three days taken in the study was compared between treatments using logistic regression with a cumulative logit model. From this analysis the frequency distribution (%) of number days escape medication was used was presented together with the odds ratio, p-value and 95% CI for the treatment contrasts.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.899
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value 0.01
Confidence Interval (2-Sided) 95%
-0.19 to 0.22
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Sleep Disturbance 0-10 Numerical Rating Scale
Hide Description The sleep disruption NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate how your pain disrupted your sleep last night?" where 0 = did not disrupt sleep and 10 = completely disrupted (unable to sleep at all). A negative value indicates an improvement in sleep disruption score from baseline.
Time Frame 2 weeks: baseline to end of week 2 (last 3 days of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.
Arm/Group Title Sativex THC Alone Placebo
Hide Arm/Group Description:
Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
Overall Number of Participants Analyzed 54 54 56
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.59  (1.88) -0.25  (2.33) -0.21  (1.72)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of < 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.346
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -0.31
Confidence Interval (2-Sided) 95%
-0.97 to 0.34
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection THC Alone, Placebo
Comments Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of < 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.95
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value 0.02
Confidence Interval (2-Sided) 95%
-0.64 to 0.68
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Nausea 0-10 Numerical Rating Scale
Hide Description The nausea NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate how sick you felt throughout the day?" where 0 = not sick at all and 10 = very sick. A negative value indicates an improvement in nausea score from baseline.
Time Frame 2 weeks; baseline - end of week 2 (last 3 days of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.
Arm/Group Title Sativex THC Alone Placebo
Hide Arm/Group Description:
Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
Overall Number of Participants Analyzed 54 54 56
Mean (Standard Deviation)
Unit of Measure: units on a scale
0  (2.19) 0.27  (1.83) -0.16  (1.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of < 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value 0.49
Confidence Interval (2-Sided) 95%
-0.11 to 1.09
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection THC Alone, Placebo
Comments Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of < 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.126
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value 0.46
Confidence Interval (2-Sided) 95%
-0.13 to 1.05
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Memory 0-10 Numerical Rating Scale
Hide Description The memory NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate how well you are able to remember what you have done in the past 24 hours?" where 0 = very well and 10 = not at all. A negative value indicates an improvement in memory score from baseline.
Time Frame 2 weeks: baseline - end of week 2 (last 3 days of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.
Arm/Group Title Sativex THC Alone Placebo
Hide Arm/Group Description:
Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
Overall Number of Participants Analyzed 54 54 56
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.58  (2.06) 0.57  (1.90) 0  (1.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of < 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.045
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value 0.65
Confidence Interval (2-Sided) 95%
0.01 to 1.28
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection THC Alone, Placebo
Comments Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of < 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.053
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value 0.62
Confidence Interval (2-Sided) 95%
-0.01 to 1.25
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Appetite 0-10 Numerical Rating Scale
Hide Description The appetite NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate how your appetite has been throughout the day?" where 0 = very good and 10 = very poor. A negative value indicates an improvement in appetite score from baseline.
Time Frame 2 weeks: baseline - end of week 2 (last 3 days of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.
Arm/Group Title Sativex THC Alone Placebo
Hide Arm/Group Description:
Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
Overall Number of Participants Analyzed 54 54 56
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.24  (2.29) 0.18  (1.91) -1.65  (1.94)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of < 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter estimated mean treatment difference
Estimated Value 0.83
Confidence Interval (2-Sided) 95%
0.16 to 1.51
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection THC Alone, Placebo
Comments Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of < 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.056
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value 0.66
Confidence Interval (2-Sided) 95%
-0.02 to 1.33
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Concentration 0-10 Numerical Rating Scale
Hide Description The concentration NRS was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate how well have you been able to concentrate throughout the day e.g. when reading a newspaper?" where 0 = very well and 10 = not at all. A negative value indicates an improvement in concentration score from baseline.
Time Frame 2 weeks: baseline - end of week 2 (last 3 days of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.
Arm/Group Title Sativex THC Alone Placebo
Hide Arm/Group Description:
Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
Overall Number of Participants Analyzed 54 54 56
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.26  (1.66) 0.22  (1.80) -0.32  (1.39)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of < 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.021
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value 0.68
Confidence Interval (2-Sided) 95%
0.10 to 1.25
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection THC Alone, Placebo
Comments Each secondary variable was tested using a two-sided significance level of α=0.05, unless otherwise specified. P-values of < 0.05 were considered statistically significant. If the overall treatment effect for the secondary variables was statistically significant then treatment comparisons was made between active treatments and placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.028
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment difference
Estimated Value 0.64
Confidence Interval (2-Sided) 95%
0.07 to 1.22
Estimation Comments [Not Specified]
8.Secondary Outcome
Title EORTC Quality of Life Questionnaire (EORTC-QLQC30)
Hide Description Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), a core cancer-specific questionnaire containing 30 items on patients' functioning, global quality of life, disease- and treatment related symptoms. Higher scores indicate a greater degree of symptoms, min.: 0, Max.: 100
Time Frame 2 weeks; baseline and end of treatment (2 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.
Arm/Group Title Sativex THC Alone Placebo
Hide Arm/Group Description:
Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
Overall Number of Participants Analyzed 49 50 52
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.93  (17.51) 3.57  (18.32) 4.74  (18.50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments Analysis of the change from baseline was assessed using ANCOVA, adjusting for the effects of the baseline value. The significance of the treatment effect, after adjusting for the baseline value, was assessed using the F-test from the ANCOVA. If found significant at the 5% level, then the mean difference between treatments together with 95% CI were presented.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.443
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter estimated mean treatment difference
Estimated Value 2.47
Confidence Interval (2-Sided) 95%
-3.87 to 8.81
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection THC Alone, Placebo
Comments Analysis of the change from baseline was assessed using ANCOVA, adjusting for the effects of the baseline value. The significance of the treatment effect, after adjusting for the baseline value, was assessed using the F-test from the ANCOVA. If found significant at the 5% level, then the mean difference between treatments together with 95% CI were presented.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.793
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter estimated mean treatment difference
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
-5.46 to 7.13
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Brief Pain Inventory Short Form
Hide Description The BPI-SF 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 was calculated as the arithmetic mean of the four severity items(range 0-10). The minimum value is zero and maximum is 10. A higher score represents a poor outcome.
Time Frame End of 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who were randomised, received at least one actuation of study medication and had on-treatment efficacy data were included in the ITT population, used for this analysis.
Arm/Group Title Sativex THC Alone Placebo
Hide Arm/Group Description:
Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
Each 100 μl actuation of THC delivered a dose containing 2.7 mg THC only. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations (130 mg) in any 24 hour period.
Each actuation of placebo delivered the excipients plus colourants. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
Overall Number of Participants Analyzed 15 17 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.2  (5.63) -3.38  (6.43) 0.41  (5.55)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments Change in pain scores on-treatment were be compared between groups using analysis of covariance (ANCOVA). The baseline pain score was fitted as a covariate in the model. The significance of the treatment effect after adjusting for baseline pain score was assessed using the F-test from the ANCOVA. If this was significant at the 5% level, then the mean difference between treatments together with the 95% confidence interval was presented for Sativex versus placebo and THC versus placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.619
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -1.04
Confidence Interval (2-Sided) 95%
-5.23 to 3.15
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection THC Alone, Placebo
Comments Change in pain scores on-treatment were be compared between groups using analysis of covariance (ANCOVA). The baseline pain score was fitted as a covariate in the model. The significance of the treatment effect after adjusting for baseline pain score was assessed using the F-test from the ANCOVA. If this was significant at the 5% level, then the mean difference between treatments together with the 95% confidence interval was presented for Sativex versus placebo and THC versus placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.048
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -4.07
Confidence Interval (2-Sided) 95%
-8.10 to -0.05
Estimation Comments [Not Specified]
Time Frame All adverse events (AEs) occurring from the time of consent to post study follow up (14 - 20 days) were collected. All deaths and serious adverse events (SAEs) occurring within 28 days of the final dose of study medication were also collected.
Adverse Event Reporting Description All AEs occurring during the study were reported on the running logs at the back of the study case report form.
 
Arm/Group Title Sativex THC Alone Placebo
Hide Arm/Group Description Maximum number of daily sprays was 48 giving a maximum daily dose of 130 mg THC and 120 mg CBD Maximum number of daily sprays was 48 giving a maximum daily dose of 130 mg THC Maximum number of daily sprays was 48
All-Cause Mortality
Sativex THC Alone Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sativex THC Alone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/60 (21.67%)      13/58 (22.41%)      7/59 (11.86%)    
Cardiac disorders       
Cardio-respiratory arrest  1  0/60 (0.00%)  0/58 (0.00%)  2/59 (3.39%) 
Gastrointestinal disorders       
Gastric ulcer haemorrhage  1  0/60 (0.00%)  0 1/58 (1.72%)  0/59 (0.00%)  0
Nausea  1  0/60 (0.00%)  0 1/58 (1.72%)  0/59 (0.00%)  0
Nausea aggravated  1  1/60 (1.67%)  0/58 (0.00%)  0 0/59 (0.00%)  0
General disorders       
Disease progression nos  1  1/60 (1.67%)  1/58 (1.72%)  0/59 (0.00%)  0
Chest pain  1  0/60 (0.00%)  0 0/58 (0.00%)  0 1/59 (1.69%) 
Malaise  1  0/60 (0.00%)  0 1/58 (1.72%)  0/59 (0.00%)  0
Weakness  1  1/60 (1.67%)  0/58 (0.00%)  0 0/59 (0.00%)  0
Infections and infestations       
Bronchopneumonia nos  1  0/60 (0.00%)  0 1/58 (1.72%)  0/59 (0.00%)  0
Oral candidiasis  1  0/60 (0.00%)  0 1/58 (1.72%)  0/59 (0.00%)  0
Investigations       
Blood urine present  1  1/60 (1.67%)  0/58 (0.00%)  0 0/59 (0.00%)  0
Metabolism and nutrition disorders       
Hyperglycaemia nos  1  0/60 (0.00%)  0 1/58 (1.72%)  0/59 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Back pain  1  0/60 (0.00%)  0 1/58 (1.72%)  0/59 (0.00%) 
Chest wall pain  1  0/60 (0.00%)  0 0/58 (0.00%)  0 1/59 (1.69%) 
Groin pain  1  0/60 (0.00%)  0 0/58 (0.00%)  0 1/59 (1.69%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Neoplasm progression nos  1  6/60 (10.00%)  5/58 (8.62%)  2/59 (3.39%) 
Malignant neoplasm progression  1  0/60 (0.00%)  0 0/58 (0.00%)  0 2/59 (3.39%) 
Metastases to brain  1  0/60 (0.00%)  0 2/58 (3.45%)  0/59 (0.00%)  0
Metastases to prostate  1  0/60 (0.00%)  0 0/58 (0.00%)  0 1/59 (1.69%) 
Tumour haemorrhage  1  1/60 (1.67%)  0/58 (0.00%)  0 0/59 (0.00%)  0
Tumour pain  1  1/60 (1.67%)  0/58 (0.00%)  0 0/59 (0.00%)  0
Nervous system disorders       
Somnolence  1  1/60 (1.67%)  2/58 (3.45%)  1/59 (1.69%) 
Cerebrovascular accident  1  0/60 (0.00%)  0 1/58 (1.72%)  0/59 (0.00%)  0
Spinal cord compression nos  1  1/60 (1.67%)  0/58 (0.00%)  0 0/59 (0.00%)  0
Syncope  1  0/60 (0.00%)  0 1/58 (1.72%)  0/59 (0.00%)  0
Tremor  1  0/60 (0.00%)  0 1/58 (1.72%)  0/59 (0.00%)  0
Psychiatric disorders       
Confusion  1  0/60 (0.00%)  0 2/58 (3.45%)  1/59 (1.69%) 
Anxiety  1  0/60 (0.00%)  0 0/58 (0.00%)  0 1/59 (1.69%) 
Disorientation  1  0/60 (0.00%)  0 1/58 (1.72%)  0/59 (0.00%)  0
Renal and urinary disorders       
Urinary retention  1  2/60 (3.33%)  0/58 (0.00%)  0 0/59 (0.00%)  0
Renal Failure nos  1  0/60 (0.00%)  0 1/58 (1.72%)  0/59 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Dyspnoea nos  1  0/60 (0.00%)  0 0/58 (0.00%)  0 1/59 (1.69%) 
Social circumstances       
Family stress nos  1  0/60 (0.00%)  0 0/58 (0.00%)  0 1/59 (1.69%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 5.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sativex THC Alone Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   51/60 (85.00%)      45/58 (77.59%)      44/59 (74.58%)    
Ear and labyrinth disorders       
Vertigo  1  3/60 (5.00%)  0/58 (0.00%)  1/59 (1.69%) 
Gastrointestinal disorders       
Nausea  1  7/60 (11.67%)  6/58 (10.34%)  6/59 (10.17%) 
Vomiting  1  5/60 (8.33%)  4/58 (6.90%)  4/59 (6.78%) 
Diarrhoea NOS  1  4/60 (6.67%)  0/58 (0.00%)  2/59 (3.39%) 
Constipation  1  3/60 (5.00%)  0/58 (0.00%)  6/59 (10.17%) 
General disorders       
Weakness  1  3/60 (5.00%)  0/58 (0.00%)  0/59 (0.00%) 
Oral pain  1  0/60 (0.00%)  5/58 (8.62%)  3/59 (5.08%) 
Glossodynia  1  0/60 (0.00%)  5/58 (8.62%)  0/59 (0.00%) 
Fatigue  1  0/60 (0.00%)  3/58 (5.17%)  0/59 (0.00%) 
Chest Pain  1  0/60 (0.00%)  3/58 (5.17%)  1/59 (1.69%) 
Investigations       
Liver function test NOS abnormal  1  3/60 (5.00%)  0/58 (0.00%)  2/59 (3.39%) 
Gamma-glutamyltransferase increased  1  0/60 (0.00%)  5/58 (8.62%)  3/59 (5.08%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Neoplasm progression NOS  1  6/60 (10.00%)  5/58 (8.62%)  3/59 (5.08%) 
Nervous system disorders       
Somnolence  1  9/60 (15.00%)  8/58 (13.79%)  8/59 (13.56%) 
Dizziness  1  7/60 (11.67%)  7/58 (12.07%)  3/59 (5.08%) 
Psychiatric disorders       
Confusion  1  4/60 (6.67%)  0/58 (0.00%)  2/59 (3.39%) 
Renal and urinary disorders       
Urinary retention  1  3/60 (5.00%)  0/58 (0.00%)  0/59 (0.00%) 
Vascular disorders       
Hypotension NOS  1  3/60 (5.00%)  0/58 (0.00%)  0/59 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 5.0
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
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
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Responsible Party: Mr Richard Potts/ Clinical Operations Director, GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT00674609     History of Changes
Other Study ID Numbers: GWCA0101
First Submitted: April 28, 2008
First Posted: May 8, 2008
Results First Submitted: July 5, 2012
Results First Posted: August 13, 2012
Last Update Posted: June 20, 2013