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A Study of Sativex® for Pain Relief Due to Diabetic Neuropathy

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ClinicalTrials.gov Identifier: NCT00710424
Recruitment Status : Completed
First Posted : July 4, 2008
Results First Posted : July 31, 2012
Last Update Posted : August 1, 2012
Sponsor:
Information provided by (Responsible Party):
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 Pain
Diabetic Neuropathy
Interventions Drug: Sativex
Drug: Placebo
Enrollment 297
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sativex Placebo
Hide Arm/Group Description Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
Period Title: Overall Study
Started 149 148
Completed 105 125
Not Completed 44 23
Reason Not Completed
Adverse Event             30             12
Lack of Efficacy             4             5
Withdrawal by Subject             5             3
Lost to Follow-up             0             1
Refused medication, no side effects             1             0
Non-compliance with stable analgesia             1             0
Did not meet entry criteria at visit 1             1             0
Subject thought medication changed             1             0
Ceased treatment due to travel             1             0
Subject preferred paracetamol             0             1
Felt good so stopped treatment             0             1
Arm/Group Title Sativex Placebo Total
Hide Arm/Group Description Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours. Total of all reporting groups
Overall Number of Baseline Participants 149 148 297
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 149 participants 148 participants 297 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
97
  65.1%
119
  80.4%
216
  72.7%
>=65 years
52
  34.9%
29
  19.6%
81
  27.3%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 149 participants 148 participants 297 participants
60.8  (10.38) 58.2  (10.57) 59.5  (10.54)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 149 participants 148 participants 297 participants
Female
56
  37.6%
58
  39.2%
114
  38.4%
Male
93
  62.4%
90
  60.8%
183
  61.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 149 participants 148 participants 297 participants
United Kingdom 91 86 177
Czech Republic 34 37 71
Romania 24 25 49
1.Primary Outcome
Title The Change From Baseline in Mean Diabetic Neuropathy Pain 0-10 Numerical Rating Scale Score at the End of Treatment (Average of Last 7 Days Treatment)
Hide Description The diabetic neuropathy pain Numerical Rating Scale was complete at the end of every day. The patient was asked "on a scale of '0 to 10', please indicate the number that best describes your nerve pain due to diabetes in the last 24 hours" where 0 = no pain and 10 = worst possible pain. No pain relates to the time prior to the onset of pain due to diabetic neuropathy. For those whose evaluable period ended before Day 7, the mean of the available post-randomisation data was used. Those with no post-baseline diary pain 0-10 Numerical Rating Scale scores were excluded from the analysis.
Time Frame Day 0 to Day 98
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
Overall Number of Participants Analyzed 146 148
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.67  (2.13) -1.55  (2.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The model used for the analysis of the end of study value was an analysis of covariance (ANCOVA) with baseline value as a covariate and treatment group and centre group as main effect. The test was performed at the 10% significance level as a possible indicator of an interactive effect. The null hypothesis was one of no difference between treatments.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.634
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter estimated treatment effect
Estimated Value -0.12
Confidence Interval (2-Sided) 95%
-0.60 to 0.36
Estimation Comments A negative difference in treatment effect indicates an improvement in pain in favour of Sativex.
2.Primary Outcome
Title Number of Responders at the 30% Improvement Level at the End of Treatment
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 14 (last 7 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. The average pain NRS was completed at the same time each day, i.e. bedtime in the evening. Estimates were produced for a one-week period, with the evaluable period finishing at the end of the appropriate seven-day period.
Time Frame Day 0 - Day 98
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects who were randomised and received at least one actuation of study medication were included in the analysis. Subjects with no data during the primary period (i.e. unknown response) were included in the analysis, and were classed as non-responders.
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
Overall Number of Participants Analyzed 149 148
Measure Type: Number
Unit of Measure: participants
54 59
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The numbers of responders were to be analysed using the difference in proportions and the odds ratio comparing the treatment groups with the provision of 95% CIs for the difference and odds ratio.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.521
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.857
Confidence Interval (2-Sided) 95%
0.537 to 1.370
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in Mean Neuropathic Pain Scale Score at the End of Treatment
Hide Description The Neuropathic Pain Scale score is the 0-100 sum of 10 individual pain scores (0-10 Numerical Rating Scale, 0= no pain to 10 = most pain imaginable). A negative change from baseline indicates an improvement in pain. The baseline mean Neuropathic Pain Scale score was to be the mean of the two assessments during the baseline period, with the end of study value as the mean of the last two assessments made during the evaluable period.
Time Frame Day 0 to Day 98
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
Overall Number of Participants Analyzed 135 140
Mean (Standard Deviation)
Unit of Measure: units on a scale
-13.70  (19.91) -14.16  (17.42)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The change from baseline in mean neuropathic pain scale scale score at the end of treatment was to be compared between treatment groups using ANCOVA. The model was to include treatment and centre group as factors and baseline mean usage as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.865
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value 0.37
Confidence Interval (2-Sided) 95%
-3.87 to 4.61
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.153
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in Mean Sleep Quality 0-10 Numerical Rating Scale Score at the End of Treatment
Hide Description The sleep quality Numerical Rating Scale 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 sleep quality in the last 24 hours" where 0 = slept extremely well and 10 = unable to sleep at all. A negative value indicates an improvement in pain score from baseline. The analyses were based on the change from baseline for the last assessment falling within the evaluable period (considered the end of treatment).
Time Frame Day 0 - Day 98
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
Overall Number of Participants Analyzed 132 142
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.0  (3.02) -1.6  (2.76)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The change from baseline in mean sleep quality numerical rating scale score at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment and centre group as factors and baseline mean usage as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.139
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimated mean treatment difference
Estimated Value -0.45
Confidence Interval (2-Sided) 95%
-1.04 to 0.15
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Subject Global Impression of Change at the End of Treatment
Hide Description The subject was to assess the change in their nerve pain due to diabetic neuropathy at the end of the study compared to baseline on a 7-point scale from very much worse to very much improved. The number of participants reporting each score is presented.
Time Frame Day 0 and Day 98
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
Overall Number of Participants Analyzed 140 141
Measure Type: Number
Unit of Measure: participants
Very Much Improved 13 14
Much Improved 40 36
Slightly Improved 48 35
No Change 30 45
Slightly worse 6 9
Much worse 2 2
Very much worse 1 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments In the analysis of Subject Global Impression of Change, the two treatment groups were compared using ordinal logistic regression and the proportional odds model. The model incorporated centre group as a factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.219
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.301
Confidence Interval (2-Sided) 95%
0.855 to 1.981
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in Mean Brief Pain Inventory (Short Form)'Pain Severity Composite Score' at the End of Treatment
Hide Description The brief pain inventory (short form) 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 pain 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 Day 0 and Day 98
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
Overall Number of Participants Analyzed 137 135
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.2  (1.92) -1.2  (2.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The change from baseline in mean brief pain inventory (short form) composite score at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment and centre group as factors and baseline mean usage as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.841
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter estimated mean treatment difference
Estimated Value -0.05
Confidence Interval (2-Sided) 95%
-0.51 to 0.42
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Mean Quality of Life EuroQol 5-D Weighted Health State Index Score at the End of Treatment Measured by Visual Analogue Scale
Hide Description The EuroQol-5D Health Status Visual Analogue Scale rated the health state on a scale of 0-100 with 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score indicates an improvement in condition.
Time Frame Day 0 and Day 98
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
Overall Number of Participants Analyzed 138 135
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.3  (22.26) 7.8  (22.91)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The change from baseline in weighted health state index score at the end of treatment was compared between treatment groups using ANCOVA. The model included treatment and centre group as factors and baseline symptom score as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.523
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-0.06 to 0.03
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.021
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Change From Baseline in the Use of Rescue Analgesia at the End of Treatment
Hide Description The mean daily number of paracetamol tablets used were calculated for the periods over which the primary endpoint was calculated.
Time Frame Day 0 - Day 98
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
Overall Number of Participants Analyzed 146 148
Mean (Standard Deviation)
Unit of Measure: Tablets
-0.53  (2.02) -0.35  (1.94)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sativex, Placebo
Comments The model used for the analysis of the end of study value was ANCOVA with baseline value as a covariate and treatment group and centre group as main effect. The test was performed at the 10% significance level as a possible indicator of an interactive effect. The null hypothesis was one of no difference between treatments. A negative difference in adjusted means indicates an improvement in favour of Sativex.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.410
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter estimated mean treatment difference
Estimated Value -0.17
Confidence Interval (2-Sided) 95%
-0.59 to 0.24
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Incidence of Adverse Events as a Measure of Subject Safety
Hide Description The number of subjects who experienced an adverse event during the course of the study (including the follow-up period i.e 28 days after the end of treatment) is presented.
Time Frame Day 0 - Day 133
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
Overall Number of Participants Analyzed 149 148
Measure Type: Number
Unit of Measure: participants
All-causality relationship to study medication 120 101
Plausibly related to study medication 96 52
10.Secondary Outcome
Title Change From Baseline in Mean Intoxication 0-10 Numerical Rating Scale Score at the End of Treatment
Hide Description Subjects rated their intoxication levels on a scale of 0-10, where 0 equals “no intoxication” and 10 equals “extreme intoxication”. A negaitve value from baseline indicates and improvement. End of treatment was classed as the last on-treatment visit where data was recorded.
Time Frame Day 0 - Day 98
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The primary population for analysis was the full analysis set, which included all randomised subjects who received at least one dose of study medication and yielded on-treatment efficacy data.
Arm/Group Title Sativex Placebo
Hide Arm/Group Description:
Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
Overall Number of Participants Analyzed 142 145
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.8  (2.73) -0.3  (1.96)
Time Frame All adverse events occurring from the time of consent to post study follow up i.e. 19 weeks 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 Sativex Placebo
Hide Arm/Group Description Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
All-Cause Mortality
Sativex Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sativex Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   14/149 (9.40%)   12/148 (8.11%) 
Cardiac disorders     
ACUTE CORONARY SYNDROME  1  1/149 (0.67%)  0/148 (0.00%) 
BRADYCARDIA  1  1/149 (0.67%)  0/148 (0.00%) 
MYOCARDIAL INFARCTION  1  1/149 (0.67%)  1/148 (0.68%) 
Eye disorders     
EYE HAEMORRHAGE  1  0/149 (0.00%)  1/148 (0.68%) 
Gastrointestinal disorders     
GASTROINTESTINAL INFLAMMATION  1  1/149 (0.67%)  0/148 (0.00%) 
PERIODONTITIS  1  1/149 (0.67%)  0/148 (0.00%) 
ABDOMINAL PAIN  1  0/149 (0.00%)  1/148 (0.68%) 
GASTRITIS  1  0/149 (0.00%)  1/148 (0.68%) 
HAEMATEMESIS  1  0/149 (0.00%)  1/148 (0.68%) 
IMPAIRED GASTRIC EMPTYING  1  0/149 (0.00%)  1/148 (0.68%) 
NAUSEA  1  0/149 (0.00%)  1/148 (0.68%) 
VOMITING  1  0/149 (0.00%)  1/148 (0.68%) 
General disorders     
OEDEMA PERIPHERAL  1  0/149 (0.00%)  1/148 (0.68%) 
PYREXIA  1  0/149 (0.00%)  1/148 (0.68%) 
Infections and infestations     
CELLULITIS  1  1/149 (0.67%)  0/148 (0.00%) 
LOWER RESPIRATORY TRACT INFECTION  1  1/149 (0.67%)  0/148 (0.00%) 
Investigations     
BLOOD GLUCOSE INCREASED  1  0/149 (0.00%)  1/148 (0.68%) 
Metabolism and nutrition disorders     
DIABETIC KETOACIDOSIS  1  1/149 (0.67%)  0/148 (0.00%) 
HYPERGLYCAEMIA  1  1/149 (0.67%)  0/148 (0.00%) 
KETOACIDOSIS  1  1/149 (0.67%)  0/148 (0.00%) 
DIABETES MELLITUS INADEQUATE CONTROL  1  0/149 (0.00%)  1/148 (0.68%) 
Musculoskeletal and connective tissue disorders     
BACK PAIN  1  1/149 (0.67%)  0/148 (0.00%) 
EXOSTOSIS  1  1/149 (0.67%)  0/148 (0.00%) 
MUSCULOSKELETAL CHEST PAIN  1  0/149 (0.00%)  1/148 (0.68%) 
RHABDOMYOLYSIS  1  0/149 (0.00%)  1/148 (0.68%) 
Nervous system disorders     
ISCHAEMIC STROKE  1  1/149 (0.67%)  0/148 (0.00%) 
SYNCOPE  1  1/149 (0.67%)  0/148 (0.00%) 
TRANSIENT ISCHAEMIC ATTACK  1  0/149 (0.00%)  1/148 (0.68%) 
Renal and urinary disorders     
RENAL FAILURE  1  0/149 (0.00%)  1/148 (0.68%) 
Vascular disorders     
ESSENTIAL HYPERTENSION  1  1/149 (0.67%)  0/148 (0.00%) 
PERIPHERAL OCCLUSIVE DISEASE  1  1/149 (0.67%)  0/148 (0.00%) 
ACCELERATED HYPERTENSION  1  0/149 (0.00%)  1/148 (0.68%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 8.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Sativex Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   120/149 (80.54%)   101/148 (68.24%) 
Cardiac disorders     
Palpitations  1  4/149 (2.68%)  1/148 (0.68%) 
Ear and labyrinth disorders     
Vertigo  1  6/149 (4.03%)  3/148 (2.03%) 
Gastrointestinal disorders     
Nausea  1  25/149 (16.78%)  15/148 (10.14%) 
Vomiting  1  14/149 (9.40%)  11/148 (7.43%) 
Dry mouth  1  12/149 (8.05%)  4/148 (2.70%) 
Diarrhoea  1  10/149 (6.71%)  14/148 (9.46%) 
Oral pain  1  7/149 (4.70%)  0/148 (0.00%) 
Abdominal pain upper  1  5/149 (3.36%)  2/148 (1.35%) 
Mouth ulceration  1  4/149 (2.68%)  2/148 (1.35%) 
Oral discomfort  1  4/149 (2.68%)  4/148 (2.70%) 
General disorders     
Fatigue  1  10/149 (6.71%)  4/148 (2.70%) 
Feeling abnormal  1  4/149 (2.68%)  0/148 (0.00%) 
Oedema peripheral  1  4/149 (2.68%)  2/148 (1.35%) 
Infections and infestations     
Nasopharyngitis  1  8/149 (5.37%)  6/148 (4.05%) 
Lower respiratory tract infection  1  6/149 (4.03%)  8/148 (5.41%) 
Urinary tract infection  1  2/149 (1.34%)  8/148 (5.41%) 
Metabolism and nutrition disorders     
Hypoglycaemia  1  9/149 (6.04%)  5/148 (3.38%) 
Musculoskeletal and connective tissue disorders     
Pain in extremity  1  4/149 (2.68%)  4/148 (2.70%) 
Back pain  1  3/149 (2.01%)  5/148 (3.38%) 
Arthralgia  1  2/149 (1.34%)  4/148 (2.70%) 
Muscle spasms  1  2/149 (1.34%)  4/148 (2.70%) 
Nervous system disorders     
Dizziness  1  42/149 (28.19%)  7/148 (4.73%) 
Somnolence  1  11/149 (7.38%)  7/148 (4.73%) 
Headache  1  9/149 (6.04%)  11/148 (7.43%) 
Lethargy  1  5/149 (3.36%)  1/148 (0.68%) 
Amnesia  1  4/149 (2.68%)  2/148 (1.35%) 
Dysgeusia  1  4/149 (2.68%)  1/148 (0.68%) 
Memory impairment  1  4/149 (2.68%)  1/148 (0.68%) 
Psychiatric disorders     
Disorientation  1  8/149 (5.37%)  1/148 (0.68%) 
Depression  1  5/149 (3.36%)  2/148 (1.35%) 
Insomnia  1  0/149 (0.00%)  4/148 (2.70%) 
Respiratory, thoracic and mediastinal disorders     
Pharyngolaryngeal pain  1  6/149 (4.03%)  4/148 (2.70%) 
Cough  1  2/149 (1.34%)  4/148 (2.70%) 
Skin and subcutaneous tissue disorders     
Pruritus  1  1/149 (0.67%)  5/148 (3.38%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 8.1
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 Pharm Ltd
Phone: 0044 1223 266800
Responsible Party: GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT00710424     History of Changes
Other Study ID Numbers: GWCL0305
First Submitted: July 2, 2008
First Posted: July 4, 2008
Results First Submitted: June 26, 2012
Results First Posted: July 31, 2012
Last Update Posted: August 1, 2012