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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: NCT00530764
Recruitment Status : Completed
First Posted : September 17, 2007
Results First Posted : June 17, 2011
Last Update Posted : June 20, 2013
Sponsor:
Collaborator:
Quintiles, Inc.
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: Supportive Care
Conditions Palliative Care
Pain
Cancer
Interventions Drug: Sativex Low Dose
Drug: Sativex Medium Dose
Drug: Sativex High Dose
Enrollment 360
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sativex High Dose Group Sativex Medium Dose Group Sativex Low Dose Group Placebo
Hide Arm/Group Description Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD. Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD. Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD. Range of 1-16 sprays per day of placebo spray
Period Title: Overall Study
Started 90 88 91 91
Completed 59 67 71 66
Not Completed 31 21 20 25
Arm/Group Title Sativex High Dose Group Sativex Medium Dose Group Sativex Low Dose Group Placebo Total
Hide Arm/Group Description Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD. Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD. Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD. Range of 1-16 sprays per day of placebo spray Total of all reporting groups
Overall Number of Baseline Participants 90 88 91 91 360
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 90 participants 88 participants 91 participants 91 participants 360 participants
58  (11.2) 59  (31.1) 59  (12.3) 56  (12.2) 58  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants 88 participants 91 participants 91 participants 360 participants
Female
42
  46.7%
39
  44.3%
46
  50.5%
47
  51.6%
174
  48.3%
Male
48
  53.3%
49
  55.7%
45
  49.5%
44
  48.4%
186
  51.7%
1.Primary Outcome
Title Number of Patients With at Least 30% Improvement in Numerical Rating Scale (NRS) Average Pain Score From Baseline
Hide Description A positive 30% pain response is defined as a reduction of at least 30% in the mean NRS average pain score from baseline to week 5 (last 3 days). 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. The average pain NRS was completed at the same time each day, i.e. bedtime in the evening.
Time Frame 5 Weeks: Baseline (first 3 days) - Week 5 (last 3 days)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sativex High Dose Group Sativex Medium Dose Group Sativex Low Dose Group Placebo
Hide Arm/Group Description:
Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
Range of 1-16 sprays per day of placebo spray
Overall Number of Participants Analyzed 90 87 91 91
Measure Type: Number
Unit of Measure: Participants
22 26 30 24
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex Low Dose Group, Placebo
Comments The proportions of responders were compared between the treatment groups using logistic regression with region and treatment groups as factors. The null hypothesis was that there was no difference between each of the Sativex treatment groups and placebo. The estimated response rates, odds ratios, 95% CIs for the odds ratios and p-values were presented.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.33
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.37
Confidence Interval (2-Sided) 95%
0.72 to 2.60
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sativex High Dose Group, Placebo
Comments As for Sativex Low dose versus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.62
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.90
Confidence Interval (2-Sided) 95%
0.46 to 1.76
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Sativex Medium Dose Group, Placebo
Comments As for Sativex Low dose versus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.61
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.19
Confidence Interval (2-Sided) 95%
0.62 to 2.28
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in Cumulative Average Pain Response Curves
Hide Description

The cumulative response to treatment is the percentage changes from baseline in the mean NRS pain score as defined as the 30% response.

The pain 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 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.
Time Frame Baseline to end of treatment (Week 5)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sativex High Dose Group Sativex Medium Dose Group Sativex Low Dose Group Placebo
Hide Arm/Group Description:
Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
Range of 1-16 sprays per day of placebo spray
Overall Number of Participants Analyzed 89 87 89 91
Median (Inter-Quartile Range)
Unit of Measure: Percent Change
-13
(-30 to 6)
-20
(-40 to -6)
-20
(-48 to -8)
-10
(-33 to 5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex Low Dose Group, Placebo
Comments Each of the active treatment groups were compared with placebo using pairwise Wilcoxon rank-sum tests. The Hodges-Lehmann estimates and 95% CI for the median differences were also presented.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0077
Comments [Not Specified]
Method Wilcoxon rank sum tests
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -12.5
Confidence Interval (2-Sided) 95%
-21.35 to -3.33
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sativex High Dose Group, Placebo
Comments As for Sativex low dose versus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.67
Comments [Not Specified]
Method Wilcoxin rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -1.97
Confidence Interval (2-Sided) 95%
-11.04 to 7.14
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Sativex Medium Dose Group, Placebo
Comments As for Sativex low dose versus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.039
Comments [Not Specified]
Method Wilcoxin rank sum test
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -8.75
Confidence Interval (2-Sided) 95%
-17.14 to 0.00
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change in Mean Daily NRS Pain Score (Average Pain).
Hide Description The average 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 5 Weeks: Baseline (first 3 days) - End of Treatment (last 3 days of week 5)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sativex High Dose Sativex Medium Dose Sativex Low Dose Placebo
Hide Arm/Group Description:
Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
Range of 1-16 sprays per day of placebo spray
Overall Number of Participants Analyzed 89 87 89 91
Mean (Standard Deviation)
Unit of Measure: Points on scale
-0.9  (1.9) -1.2  (1.7) -1.6  (2.1) -0.8  (1.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex Low Dose, 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment effect
Estimated Value -0.75
Confidence Interval (2-Sided) 95%
-1.28 to -0.22
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sativex High Dose, Placebo
Comments As for Sativex low dose versus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.75
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment effect
Estimated Value -0.09
Confidence Interval (2-Sided) 95%
-0.62 to 0.44
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Sativex Medium Dose, Placebo
Comments As for Sativex low dose versus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.19
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment effect
Estimated Value -0.36
Confidence Interval (2-Sided) 95%
-0.89 to 0.18
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change in Mean Daily NRS Pain Score (Worst Pain).
Hide Description The worst pain 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 the number that best describes your worst 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 worst pain score from baseline.
Time Frame 5 Weeks: Baseline (first 3 days) - End of Treatment (last 3 days of week 5)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sativex High Dose Sativex Medium Dose Sativex Low Dose Placebo
Hide Arm/Group Description:
Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
Range of 1-16 sprays per day of placebo spray
Overall Number of Participants Analyzed 89 87 89 91
Mean (Standard Deviation)
Unit of Measure: Points on scale
-1.0  (1.9) -1.2  (1.8) -1.6  (2.2) -0.9  (2.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex Low Dose, Placebo
Comments The change in mean pain NRS score (worst pain) was analyzed using ANCOVA with the baseline value as a covariate and region and treatment group as factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment effect
Estimated Value -0.73
Confidence Interval (2-Sided) 95%
-1.30 to -0.17
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sativex High Dose, Placebo
Comments As for Sativex low dose versus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated treatment effect
Estimated Value -0.35
Confidence Interval (2-Sided) 95%
-0.81 to 0.11
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Sativex Medium Dose, Placebo
Comments As for Sativex low dose versus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.40
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated Treatment Effect
Estimated Value -0.24
Confidence Interval (2-Sided) 95%
-0.81 to 0.32
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change in Sleep Disruption NRS
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 5 Weeks: Baseline - End of Treatment (Last 3 days of Week 5)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sativex High Dose Group Sativex Medium Dose Group Sativex Low Dose Group Placebo
Hide Arm/Group Description:
Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
Range of 1-16 sprays per day of placebo spray
Overall Number of Participants Analyzed 89 87 89 91
Mean (Standard Deviation)
Unit of Measure: Points on scale
-0.7  (2.1) -0.9  (2.1) -1.5  (2.1) -0.8  (2.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex Low Dose Group, Placebo
Comments The change in mean sleep disturbance NRS score was analyzed using ANCOVA with the baseline value as a covariate and region and treatment group as factors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated Treatment Effect
Estimated Value -0.88
Confidence Interval (2-Sided) 95%
-1.45 to -0.31
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sativex High Dose Group, Placebo
Comments As for Sativex low dose versus placebo
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.78
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated Treatment Effect
Estimated Value -0.08
Confidence Interval (2-Sided) 95%
-0.65 to 0.49
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Sativex Medium Dose Group, Placebo
Comments As for Sativex low dose versus placebo.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated Treatment Effect
Estimated Value -0.33
Confidence Interval (2-Sided) 95%
-0.90 to 0.24
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change in Brief Pain Inventory - Short Form (BPI-SF)
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 Baseline (Visit 2) and End of Treatment (End of Week 5 or premature termination)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sativex High Dose Group Sativex Medium Dose Group Sativex Low Dose Group Placebo
Hide Arm/Group Description:
Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
Range of 1-16 sprays per day of placebo spray
Overall Number of Participants Analyzed 68 68 69 74
Mean (Standard Deviation)
Unit of Measure: Score on scale
-1.0  (1.9) -1.5  (1.6) -1.3  (2.3) -1.0  (1.9)
7.Secondary Outcome
Title Change in Patient Assessment of Constipation Quality of Life (PAC-QoL)
Hide Description The PAC-QoL questionnaire consists of 28 questions divided into the following areas: 4 questions on physical discomfort, 8 questions on psychosocial discomfort, 11 questions on worries/concerns and 5 questions on satisfaction. The PAC-QoL was completed at baseline and then at the end of treatment. An overall score (range 0-4) was calculated at each visit and the difference determined. A positive difference in score represents an improvement.
Time Frame Baseline (Visit 2) and End of Treatment (Week 5 or premature termination)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sativex High Dose Group Sativex Medium Dose Group Sativex Low Dose Group Placebo
Hide Arm/Group Description:
Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
Range of 1-16 sprays per day of placebo spray
Overall Number of Participants Analyzed 70 68 70 74
Mean (Standard Deviation)
Unit of Measure: Score on scale
0.0  (0.7) -0.1  (0.5) 0.0  (0.6) -0.1  (0.6)
8.Secondary Outcome
Title Change in Patient Global Impression of Change - PGIC
Hide Description A 7-point Likert-type scale was used, with the question: 'Please assess the status of your pain due to cancer since entry into the study using the scale below' with the markers "very much improved, much improved, slightly improved, no change, slightly worse, much worse or very much worse". At Visit 2 (Baseline) patients wrote a brief description of their pain caused by cancer which was used at Week 5 to aid their memory regarding their symptoms at study start. For each of above markers the number of participants were reported.
Time Frame End of Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sativex High Dose Group Sativex Medium Dose Group Sativex Low Dose Group Placebo
Hide Arm/Group Description:
Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
Range of 1-16 sprays per day of placebo spray
Overall Number of Participants Analyzed 73 71 70 72
Measure Type: Number
Unit of Measure: Participants
Very much improved 6 6 10 9
Much improved 20 19 24 16
Slightly improved 25 26 19 28
No change 13 13 13 17
Slightly worse 6 5 3 1
Much worse 1 0 1 1
Very much worse 2 2 0 0
9.Secondary Outcome
Title Change in Montgomery Asberg Depression Rating Scale (MADRS)
Hide Description The MADRS comprises of 10 questions that are completed by the patient to determine their depression level. The MADRS was completed at Visit 2 (Baseline) prior to receiving the study drug and at Visit 4 (Week 5 or premature termination). Each item is scored on a 0-6 scale , where 0=no sadness to 6=extreme and continuous gloom and despondency, and the MADRS score is the sum of the 10 item scores (range 0-60). The higher the score the more severe the depression.
Time Frame Baseline and End of Treatment (Week 5 or premature termination)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sativex High Dose Group Sativex Medium Dose Group Sativex Low Dose Group Placebo
Hide Arm/Group Description:
Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
Range of 1-16 sprays per day of placebo spray
Overall Number of Participants Analyzed 67 66 66 69
Mean (Standard Deviation)
Unit of Measure: Score on scale
-0.4  (8.6) -1.0  (8.5) -1.1  (7.0) -2.9  (9.0)
Time Frame All adverse events (AEs) occurring from the time of consent to post study follow up (Visit 5) i.e.9 weeks 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 High Dose Group Sativex Medium Dose Group Sativex Low Dose Group Placebo
Hide Arm/Group Description Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD. Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD. Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD. Range of 1-16 sprays per day of placebo spray
All-Cause Mortality
Sativex High Dose Group Sativex Medium Dose Group Sativex Low Dose Group Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Sativex High Dose Group Sativex Medium Dose Group Sativex Low Dose Group Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   28/90 (31.11%)   18/87 (20.69%)   35/91 (38.46%)   23/91 (25.27%) 
Blood and lymphatic system disorders         
Blood and Lymphatic system disorders † 1  0/90 (0.00%)  0/87 (0.00%)  4/91 (4.40%)  2/91 (2.20%) 
Cardiac disorders         
Cardiac disorders † 1  0/90 (0.00%)  0/87 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Gastrointestinal disorders         
Gastrointestinal disorders † 1  4/90 (4.44%)  3/87 (3.45%)  1/91 (1.10%)  2/91 (2.20%) 
General disorders         
General Disorders † 1 [1]  4/90 (4.44%)  1/87 (1.15%)  4/91 (4.40%)  2/91 (2.20%) 
Hepatobiliary disorders         
Hepatobiliary disorders † 1  1/90 (1.11%)  1/87 (1.15%)  0/91 (0.00%)  0/91 (0.00%) 
Infections and infestations         
Infections and Infestations † 1  2/90 (2.22%)  5/87 (5.75%)  4/91 (4.40%)  2/91 (2.20%) 
Injury, poisoning and procedural complications         
Injury, Poisoning and procedural complications † 1  0/90 (0.00%)  1/87 (1.15%)  1/91 (1.10%)  1/91 (1.10%) 
Investigations         
Investigations † 1  1/90 (1.11%)  0/87 (0.00%)  0/91 (0.00%)  0/91 (0.00%) 
Metabolism and nutrition disorders         
Metabolism and Nutrition disorders † 1  3/90 (3.33%)  1/87 (1.15%)  1/87 (1.15%)  1/91 (1.10%) 
Musculoskeletal and connective tissue disorders         
Musculoskeletal and connective tissue disorders † 1  0/90 (0.00%)  0/87 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Neoplasms benign, malignant and unspecified (Incl. Cysts and polyps) † 1  13/90 (14.44%)  12/87 (13.79%)  26/91 (28.57%)  15/91 (16.48%) 
Nervous system disorders         
Nervous system disorders † 1  3/90 (3.33%)  1/87 (1.15%)  1/91 (1.10%)  0/91 (0.00%) 
Psychiatric disorders         
Psychiatric disorders † 1  2/90 (2.22%)  1/87 (1.15%)  1/91 (1.10%)  0/91 (0.00%) 
Renal and urinary disorders         
Renal and urinary disorders † 1  4/90 (4.44%)  0/87 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
Respiratory, thoracic and mediastinal disorders         
Respiratory, thoracic and mediastinal disorders † 1  1/90 (1.11%)  1/87 (1.15%)  1/91 (1.10%)  1/91 (1.10%) 
Vascular disorders         
Vascular disorders † 1  3/90 (3.33%)  0/87 (0.00%)  0/91 (0.00%)  1/91 (1.10%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
[1]
Any new unfavorable/unintended symptoms, worsening of condition that may/not be considered related to study medication.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Sativex High Dose Group Sativex Medium Dose Group Sativex Low Dose Group Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   82/90 (91.11%)   73/87 (83.91%)   68/91 (74.73%)   69/91 (75.82%) 
Blood and lymphatic system disorders         
Blood and lymphatic system disorders † 1  9/90 (10.00%)  8/87 (9.20%)  9/91 (9.89%)  7/91 (7.69%) 
Cardiac disorders         
Cardiac disorders † 1  2/90 (2.22%)  2/87 (2.30%)  6/91 (6.59%)  6/91 (6.59%) 
Ear and labyrinth disorders         
Ear and labyrinth disorders † 1  4/90 (4.44%)  4/87 (4.60%)  0/91 (0.00%)  3/91 (3.30%) 
Eye disorders         
Eye disorders † 1  1/90 (1.11%)  4/87 (4.60%)  1/91 (1.10%)  1/91 (1.10%) 
Gastrointestinal disorders         
Gastrointestinal Disorder † 1  47/90 (52.22%)  42/87 (48.28%)  36/91 (39.56%)  29/91 (31.87%) 
General disorders         
General Disorders † 1  24/90 (26.67%)  18/87 (20.69%)  18/91 (19.78%)  20/91 (21.98%) 
Hepatobiliary disorders         
Hepatobillary Disorders † 1  2/90 (2.22%)  1/87 (1.15%)  0/91 (0.00%)  0/91 (0.00%) 
Infections and infestations         
Infections and Infestations † 1  8/90 (8.89%)  15/87 (17.24%)  11/81 (13.58%)  11/91 (12.09%) 
Injury, poisoning and procedural complications         
Injury, poisoning and procedural complications † 1  1/90 (1.11%)  2/87 (2.30%)  0/91 (0.00%)  4/91 (4.40%) 
Investigations         
Investigations † 1  5/90 (5.56%)  9/87 (10.34%)  11/91 (12.09%)  3/91 (3.30%) 
Metabolism and nutrition disorders         
Metabolism and nutrition disorders † 1  22/90 (24.44%)  15/87 (17.24%)  11/91 (12.09%)  12/91 (13.19%) 
Musculoskeletal and connective tissue disorders         
Musculoskeletal and connective tissue disorders † 1  5/90 (5.56%)  12/87 (13.79%)  6/91 (6.59%)  6/91 (6.59%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Neoplasms benign, malignant and unspecified (incl cysts and polyps) † 1  16/90 (17.78%)  12/87 (13.79%)  26/91 (28.57%)  14/91 (15.38%) 
Nervous system disorders         
Nervous system disorders † 1  44/90 (48.89%)  39/87 (44.83%)  26/91 (28.57%)  20/91 (21.98%) 
Psychiatric disorders         
Psychiatric disorders † 1  23/90 (25.56%)  14/87 (16.09%)  13/91 (14.29%)  13/91 (14.29%) 
Renal and urinary disorders         
Renal and urinary disorders † 1  8/90 (8.89%)  4/87 (4.60%)  4/91 (4.40%)  6/91 (6.59%) 
Respiratory, thoracic and mediastinal disorders         
Respiratory, thoracic and mediastinal disorders † 1  7/90 (7.78%)  6/87 (6.90%)  11/91 (12.09%)  6/91 (6.59%) 
Skin and subcutaneous tissue disorders         
Skin and subcuraneous tissue disorders † 1  7/90 (7.78%)  3/87 (3.45%)  3/91 (3.30%)  1/91 (1.10%) 
Surgical and medical procedures         
Surgical and medical procedures † 1  0/90 (0.00%)  0/87 (0.00%)  2/91 (2.20%)  0/91 (0.00%) 
Vascular disorders         
Vascular Disorders † 1  4/90 (4.44%)  3/87 (3.45%)  5/91 (5.49%)  4/91 (4.40%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
[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.

Publication Policy:

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: Matthew Hersch, Senior Clinical Project Manager
Organization: GW Pharma Ltd.
Phone: +44 1353 616600
EMail: mhersch@gwpham.com
Publications of Results:
Portenoy RK, Ganae-Motan ED, Allende S, Yanagihara R, Shaiova L, Weinstein S, McQuade R, Wright S, Fallon MT. Nabiximols for opioid-treated cancer patients with poorly-controlled chronic pain: a randomized, placebo-controlled, graded-dose trial. J Pain. 2012 May;13(5):438-49. doi: 10.1016/j.jpain.2012.01.003. Epub 2012 Apr 5.
Layout table for additonal information
Responsible Party: Jazz Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00530764    
Other Study ID Numbers: GWCA0701
First Submitted: September 13, 2007
First Posted: September 17, 2007
Results First Submitted: March 2, 2011
Results First Posted: June 17, 2011
Last Update Posted: June 20, 2013