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Study to Compare the Safety and Tolerability of Sativex® in Patients With Cancer Related Pain

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ClinicalTrials.gov Identifier: NCT00675948
Recruitment Status : Completed
First Posted : May 12, 2008
Results First Posted : September 13, 2012
Last Update Posted : June 24, 2013
Sponsor:
Information provided by (Responsible Party):
GW Pharmaceuticals Ltd.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Pain
Cancer
Interventions Drug: Sativex
Drug: GW-2000-02
Enrollment 43
Recruitment Details The first subject was recruited on the 30th April 2002
Pre-assignment Details  
Arm/Group Title Sativex THC Alone
Hide Arm/Group Description Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD Each 100 μl actuation of THC alone delivered a dose containing 2.7 mg THC
Period Title: Overall Study
Started 39 4
Completed 0 1
Not Completed 39 3
Reason Not Completed
Adverse Event             23             1
Lack of Efficacy             3             0
Withdrawal by Subject             7             0
Lost to Follow-up             2             0
Protocol Violation             1             0
Pain under control             1             0
Sponsor decision             0             1
Patient died             1             0
Patient unable to comply with diaries             1             0
Patient feels unable to take medication             0             1
Arm/Group Title Sativex THC Alone Total
Hide Arm/Group Description Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD Each 100 μl actuation of THC alone delivered a dose containing 2.7 mg THC Total of all reporting groups
Overall Number of Baseline Participants 39 4 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 4 participants 43 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
29
  74.4%
4
 100.0%
33
  76.7%
>=65 years
10
  25.6%
0
   0.0%
10
  23.3%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants 4 participants 43 participants
57.5  (13.5) 58.6  (6.28) 57.6  (12.94)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants 4 participants 43 participants
Female
16
  41.0%
3
  75.0%
19
  44.2%
Male
23
  59.0%
1
  25.0%
24
  55.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 39 participants 4 participants 43 participants
United Kingdom 31 3 34
Belgium 8 1 9
1.Primary Outcome
Title The Incidence of Adverse Events as a Measure of Subject Safety
Hide Description The number of subjects who experienced an adverse event in this study is presented.
Time Frame 0 - 657 days
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who took at least one dose of study medication and yielded on-treatment efficacy data were classed as the safety population.
Arm/Group Title Sativex THC Alone
Hide Arm/Group Description:
Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD)
Each 100 μl actuation of THC alone delivered a dose containing 2.7 mg THC
Overall Number of Participants Analyzed 39 4
Measure Type: Number
Unit of Measure: participants
37 4
2.Secondary Outcome
Title Change From Baseline in the Mean Brief Pain Inventory (Short Form) - Pain Severity Score at the End of Treatment
Hide Description The Brief Pain Inventory (Short Form) is a 14-item questionnaire that asks subjects 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 negative value indicates an improvement in score from baseline. The end of treatment was classed as study completion or withdrawal, if this occurred sooner. Calculation of the mean Brief Pain Inventory (Short Form) score was only carried out when data was available for 10 or more subjects at the relevant study visits. As such, no mean scores were calculated for subjects taking THC alone.
Time Frame 0 - 657 days
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analyses were conducted on data from all subjects who entered the study, who were randomised, who received at least one dose of study medication and who yielded on-treatment efficacy data
Arm/Group Title Sativex THC Alone
Hide Arm/Group Description:
Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD
Each 100 μl actuation of THC alone delivered a dose containing 2.7 mg THC
Overall Number of Participants Analyzed 17 0
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.53  (1.28)
3.Secondary Outcome
Title Change From Baseline in the Mean EORTC Quality of Life-C30 Questionnaire - Global Health Status Score at the End of Treatment
Hide Description The EORTC Quality of Life-C30 Health Status visual analogue scale was a self-reported score where subjects rated their health state from: 0 = worst health state imaginable to 100 = best health state imaginable. An increase in score from baseline indicates an improvement in condition. The end of treatment was classed as study completion or withdrawal, if this occurred sooner. Calculation of mean EORTC Quality of Life-C30 Health Status scores was only produced when data was available for 10 or more subjects at the relevant study visits. As such, no mean scores were calculated for subjects taking THC alone.
Time Frame 0 - 657 days
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy analyses were conducted on data from all randomised subjects who received at least one dose of study medication and who yielded on-treatment efficacy data.
Arm/Group Title Sativex THC Alone
Hide Arm/Group Description:
Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD
Each 100 μl actuation of THC alone delivered a dose containing 2.7 mg THC
Overall Number of Participants Analyzed 17 0
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.0  (28.34)
Time Frame All adverse events (AEs) occurring from the time of consent to post study follow up (2 - 521 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
Hide Arm/Group Description Each 100 μl actuation of Sativex delivered a dose containing 2.7 mg THC and 2.5 mg CBD Each 100 μl actuation of THC alone delivered a dose containing 2.7 mg THC
All-Cause Mortality
Sativex THC Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sativex THC Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   20/39 (51.28%)   1/4 (25.00%) 
Blood and lymphatic system disorders     
Anaemia NOS aggravated  1  1/39 (2.56%)  0/4 (0.00%) 
Cardiac disorders     
Atrial fibrillation  1  1/39 (2.56%)  0/4 (0.00%) 
Gastrointestinal disorders     
Haematemesis  1  2/39 (5.13%)  0/4 (0.00%) 
Diarrhoea NOS  1  1/39 (2.56%)  0/4 (0.00%) 
Intestinal obstruction NOS  1  1/39 (2.56%)  0/4 (0.00%) 
Nausea  1  1/39 (2.56%)  0/4 (0.00%) 
Vomiting NOS  1  1/39 (2.56%)  0/4 (0.00%) 
General disorders     
General physical health deterioration  1  1/39 (2.56%)  0/4 (0.00%) 
Weakness  1  1/39 (2.56%)  0/4 (0.00%) 
Infections and infestations     
Pneumonia  1  1/39 (2.56%)  0/4 (0.00%) 
Pyelonephritis NOS  1  1/39 (2.56%)  0/4 (0.00%) 
Sepsis NOS  1  1/39 (2.56%)  0/4 (0.00%) 
Urinary tract infection NOS  1  1/39 (2.56%)  0/4 (0.00%) 
Injury, poisoning and procedural complications     
Accident NOS  1  1/39 (2.56%)  0/4 (0.00%) 
Investigations     
Blood creatinine increased  1  1/39 (2.56%)  0/4 (0.00%) 
Blood potassium increased  1  1/39 (2.56%)  0/4 (0.00%) 
Blood urea increased  1  1/39 (2.56%)  0/4 (0.00%) 
Gamma-glutamyltransferase increased  1  1/39 (2.56%)  0/4 (0.00%) 
Metabolism and nutrition disorders     
Dehydration  1  1/39 (2.56%)  0/4 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/39 (2.56%)  0/4 (0.00%) 
Pain in limb  1  1/39 (2.56%)  0/4 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant neoplasm progression  1  8/39 (20.51%)  1/4 (25.00%) 
Metastases to brain  1  1/39 (2.56%)  0/4 (0.00%) 
Non-small cell lung cancer NOS  1  1/39 (2.56%)  0/4 (0.00%) 
Tumour pain  1  1/39 (2.56%)  0/4 (0.00%) 
Nervous system disorders     
Loss of consciousness  1  1/39 (2.56%)  0/4 (0.00%) 
Neuropathic pain  1  1/39 (2.56%)  0/4 (0.00%) 
Somnolence  1  1/39 (2.56%)  0/4 (0.00%) 
Psychiatric disorders     
Confusion  1  2/39 (5.13%)  0/4 (0.00%) 
Renal and urinary disorders     
Dysuria  1  1/39 (2.56%)  0/4 (0.00%) 
Renal Failure NOS  1  1/39 (2.56%)  0/4 (0.00%) 
Urinary incontinence  1  1/39 (2.56%)  0/4 (0.00%) 
Urinary retention  1  1/39 (2.56%)  0/4 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory depression  1  1/39 (2.56%)  0/4 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 5.1
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
Affected / at Risk (%) Affected / at Risk (%)
Total   37/39 (94.87%)   4/4 (100.00%) 
Blood and lymphatic system disorders     
Anaemia  1  4/39 (10.26%)  0/4 (0.00%) 
Cardiac disorders     
Atrial fibrillation  1  2/39 (5.13%)  0/4 (0.00%) 
Gastrointestinal disorders     
Nausea  1  10/39 (25.64%)  0/4 (0.00%) 
Vomiting  1  10/39 (25.64%)  1/4 (25.00%) 
Dry mouth  1  5/39 (12.82%)  0/4 (0.00%) 
Diarrhoea  1  4/39 (10.26%)  0/4 (0.00%) 
Dyspepsia  1  2/39 (5.13%)  0/4 (0.00%) 
Gastritis NOS  1  2/39 (5.13%)  0/4 (0.00%) 
Haematemesis  1  2/39 (5.13%)  0/4 (0.00%) 
General disorders     
Fatigue  1  2/39 (5.13%)  0/4 (0.00%) 
Thirst  1  2/39 (5.13%)  0/4 (0.00%) 
Weakness  1  2/39 (5.13%)  0/4 (0.00%) 
Hepatobiliary disorders     
Cholelithiasis  1  0/39 (0.00%)  1/4 (25.00%) 
Infections and infestations     
Lower respiratory tract infection NOS  1  2/39 (5.13%)  0/4 (0.00%) 
Oral candidiasis  1  2/39 (5.13%)  0/4 (0.00%) 
Cellulitis  1  0/39 (0.00%)  1/4 (25.00%) 
Urinary tract infection  1  5/39 (12.82%)  1/4 (25.00%) 
Injury, poisoning and procedural complications     
Therapeutic agent toxicity  1  0/39 (0.00%)  1/4 (25.00%) 
Investigations     
Liver function tests abnormal  1  2/39 (5.13%)  1/4 (25.00%) 
Metabolism and nutrition disorders     
Anorexia  1  2/39 (5.13%)  0/4 (0.00%) 
Musculoskeletal and connective tissue disorders     
Pain in limb  1  8/39 (20.51%)  0/4 (0.00%) 
Arthralgia  1  0/39 (0.00%)  1/4 (25.00%) 
Pain in back  1  2/39 (5.13%)  0/4 (0.00%) 
Muscle spasms  1  2/39 (5.13%)  0/4 (0.00%) 
Peripheral swelling  1  0/39 (0.00%)  1/4 (25.00%) 
Joint swelling  1  2/39 (5.13%)  0/4 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant neoplasm progression  1  11/39 (28.21%)  1/4 (25.00%) 
Metastasis to bone  1  0/39 (0.00%)  1/4 (25.00%) 
Nervous system disorders     
Dizziness  1  8/39 (20.51%)  1/4 (25.00%) 
Somnolence  1  8/39 (20.51%)  0/4 (0.00%) 
Headache  1  2/39 (5.13%)  1/4 (25.00%) 
Memory impairment  1  0/39 (0.00%)  1/4 (25.00%) 
Jerky movement  1  2/39 (5.13%)  0/4 (0.00%) 
Clonic convulsions  1  0/39 (0.00%)  1/4 (25.00%) 
Psychiatric disorders     
Confusion  1  7/39 (17.95%)  1/4 (25.00%) 
Anxiety  1  2/39 (5.13%)  0/4 (0.00%) 
Confusional state  1  2/39 (5.13%)  0/4 (0.00%) 
Depression  1  2/39 (5.13%)  0/4 (0.00%) 
Disorientation  1  2/39 (5.13%)  0/4 (0.00%) 
Hallucination NOS  1  2/39 (5.13%)  0/4 (0.00%) 
Affect lability  1  2/39 (5.13%)  0/4 (0.00%) 
Renal and urinary disorders     
Haematuria  1  0/39 (0.00%)  1/4 (25.00%) 
Urinary incontinence  1  3/39 (7.69%)  0/4 (0.00%) 
Renal failure NOS  1  0/39 (0.00%)  1/4 (25.00%) 
Renal Impairment NOS  1  0/39 (0.00%)  1/4 (25.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea NOS  1  3/39 (7.69%)  0/4 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash NOS  1  0/39 (0.00%)  1/4 (25.00%) 
Hot flushes NOS  1  0/39 (0.00%)  1/4 (25.00%) 
Vascular disorders     
Skin lesion NOS  1  0/39 (0.00%)  1/4 (25.00%) 
Hypotension NOS  1  2/39 (5.13%)  0/4 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 5.1
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.

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
Name/Title: Mr Richard Potts, Clinical Operations Director
Organization: GW Pharma LTD.
Phone: 00 44 1223 266 800
Responsible Party: GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier: NCT00675948     History of Changes
Other Study ID Numbers: GWEXT0101
First Submitted: May 8, 2008
First Posted: May 12, 2008
Results First Submitted: July 5, 2012
Results First Posted: September 13, 2012
Last Update Posted: June 24, 2013