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Study to Evaluate the Effect of GWP42003 on Liver Fat Levels in Participants With Fatty Liver Disease

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ClinicalTrials.gov Identifier: NCT01284634
Recruitment Status : Completed
First Posted : January 27, 2011
Results First Posted : January 20, 2014
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
GW Research Ltd

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Fatty Liver
Interventions Drug: GWP42003 200 mg/day Dose
Drug: GWP42003 400 mg/day Dose
Drug: GWP42003 800 mg/day Dose
Drug: Placebo
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title GWP42003 200 Milligram (mg)/Day Dose GWP42003 400 mg/Day Dose GWP42003 800 mg/Day Dose Placebo
Hide Arm/Group Description Participants self-administered one 100 mg GWP42003 capsule twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). Participants self-administered two x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). Participants self-administered four x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). Participants self-administered one, two or four placebo capsules twice daily, for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
Period Title: Overall Study
Started 7 6 7 5
Received at Least 1 Dose of Study Drug [1] 7 6 7 5
Intent to Treat (ITT) Analysis Set [2] 7 6 7 5
Completed 6 6 5 4
Not Completed 1 0 2 1
Reason Not Completed
Adverse Event             1             0             2             1
[1]
Safety analysis set; analyzed as per actual treatment received.
[2]
Randomized and received at least one dose of study medication and had on-treatment efficacy data.
Arm/Group Title GWP42003 200 mg/Day Dose GWP42003 400 mg/Day Dose GWP42003 800 mg/Day Dose Placebo Total
Hide Arm/Group Description Participants self-administered one 100 mg GWP42003 capsule twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). Participants self-administered two x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). Participants self-administered four x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). Participants self-administered one, two or four placebo capsules twice daily, for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). Total of all reporting groups
Overall Number of Baseline Participants 7 6 7 5 25
Hide Baseline Analysis Population Description
Safety Analysis Set: Participants who received at least 1 dose of investigational medicinal product (IMP); analyzed as per actual treatment received.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 6 participants 7 participants 5 participants 25 participants
40.69  (14.62) 49.08  (7.72) 46.90  (12.57) 50.41  (18.41) 46.39  (13.29)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 6 participants 7 participants 5 participants 25 participants
Female
5
  71.4%
2
  33.3%
2
  28.6%
4
  80.0%
13
  52.0%
Male
2
  28.6%
4
  66.7%
5
  71.4%
1
  20.0%
12
  48.0%
1.Primary Outcome
Title Percent Change From Baseline To The End Of Treatment (EOT) In Mean Liver Triglyceride Levels
Hide Description Liver triglyceride levels were measured by Magnetic Resonance Imaging/Magnetic Resonance Scanning and the percent change from baseline to EOT in group mean levels was investigated. A reduction from baseline, that is, a negative value, indicates an improvement in condition.
Time Frame Baseline to EOT (Day 57) or Early Termination (ET)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set: All participants who were randomized, received at least one dose of study medication, and had on-treatment efficacy data. Participants who did not have any relevant post-randomization efficacy data were excluded from the analysis.
Arm/Group Title GWP42003 200 mg/Day Dose GWP42003 400 mg/Day Dose GWP42003 800 mg/Day Dose Placebo
Hide Arm/Group Description:
Participants self-administered one 100 mg GWP42003 capsule twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
Participants self-administered two x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
Participants self-administered four x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
Participants self-administered one, two or four placebo capsules twice daily, for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
Overall Number of Participants Analyzed 7 6 6 5
Mean (Standard Deviation)
Unit of Measure: percentage change
-0.68  (4.97) -0.28  (8.60) 0.65  (5.28) 6.36  (17.97)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GWP42003 200 mg/Day Dose, Placebo
Comments The EOT liver triglyceride levels were analyzed using a linear regression model, with EOT liver triglyceride levels as the dependent variable, dose of GWP42003 as regressor, baseline liver triglyceride levels as a covariate, and gender as a factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.222
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.89
Confidence Interval (2-Sided) 90%
-16.35 to 2.56
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.454
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GWP42003 400 mg/Day Dose, Placebo
Comments The EOT liver triglyceride levels were analyzed using a linear regression model, with EOT liver triglyceride levels as the dependent variable, dose of GWP42003 as regressor, baseline liver triglyceride levels as a covariate, and gender as a factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.133
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -9.35
Confidence Interval (2-Sided) 90%
-19.66 to 0.95
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.943
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GWP42003 800 mg/Day Dose, Placebo
Comments The EOT liver triglyceride levels were analyzed using a linear regression model, with EOT liver triglyceride levels as the dependent variable, dose of GWP42003 as regressor, baseline liver triglyceride levels as a covariate, and gender as a factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.302
Comments [Not Specified]
Method Regression, Linear
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.54
Confidence Interval (2-Sided) 90%
-17.22 to 4.14
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.158
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline To The EOT In Mean Serum Total Cholesterol Levels
Hide Description A fasting blood sample was taken for the measurement of serum total cholesterol. A reduction from baseline, that is, a negative value, indicates an improvement in condition.
Time Frame Baseline to EOT (Day 57) or ET
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set: All participants who were randomized, received at least one dose of study medication, and had on-treatment efficacy data. Participants who did not have any relevant post-randomization efficacy data were excluded from the analysis.
Arm/Group Title GWP42003 200 mg/Day Dose GWP42003 400 mg/Day Dose GWP42003 800 mg/Day Dose Placebo
Hide Arm/Group Description:
Participants self-administered one 100 mg GWP42003 capsule twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
Participants self-administered two x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
Participants self-administered four x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
Participants self-administered one, two or four placebo capsules twice daily, for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
Overall Number of Participants Analyzed 7 6 7 5
Mean (Standard Deviation)
Unit of Measure: millimole (mmol)/l
0.07  (0.76) 0.03  (0.51) -0.14  (0.31) -0.62  (1.00)
3.Secondary Outcome
Title Change From Baseline To The EOT In Mean Serum High Density Lipoprotein (HDL)-Cholesterol(C) Levels
Hide Description A fasting blood sample was obtained for the measurement of HDL-C. An increase from baseline, that is, a positive value, indicates an improvement in condition.
Time Frame Baseline to EOT (Day 57) or ET
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set: All participants who were randomized, received at least one dose of study medication, and had on-treatment efficacy data. Participants who did not have any relevant post-randomization efficacy data were excluded from the analysis.
Arm/Group Title GWP42003 200 mg/Day Dose GWP42003 400 mg/Day Dose GWP42003 800 mg/Day Dose Placebo
Hide Arm/Group Description:
Participants self-administered one 100 mg GWP42003 capsule twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
Participants self-administered two x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
Participants self-administered four x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
Participants self-administered one, two or four placebo capsules twice daily, for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
Overall Number of Participants Analyzed 7 6 7 5
Mean (Standard Deviation)
Unit of Measure: mmol/l
0.07  (0.15) 0.08  (0.15) 0.06  (0.17) -0.14  (0.23)
4.Secondary Outcome
Title Change From Baseline To The EOT In Mean Serum Low-Density Lipoprotein (LDL)-C Levels
Hide Description A fasting blood sample was obtained for the measurement of LDL-C. An increase from baseline, that is, a positive value, indicates an improvement in condition.
Time Frame Baseline to EOT (Day 57) or ET
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set: All participants who were randomized, received at least one dose of study medication, and had on-treatment efficacy data. Participants who did not have any relevant post-randomization efficacy data were excluded from the analysis.
Arm/Group Title GWP42003 200 mg/Day Dose GWP42003 400 mg/Day Dose GWP42003 800 mg/Day Dose Placebo
Hide Arm/Group Description:
Participants self-administered one 100 mg GWP42003 capsule twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
Participants self-administered two x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
Participants self-administered four x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
Participants self-administered one, two or four placebo capsules twice daily, for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
Overall Number of Participants Analyzed 7 6 7 5
Mean (Standard Deviation)
Unit of Measure: mmol/l
0.11  (0.631) 0.08  (0.407) 0.00  (0.432) -0.34  (0.737)
5.Secondary Outcome
Title Change From Baseline To The EOT In Mean Serum HDL: Low Density Lipoprotein (LDL)-Cholesterol (C) Ratio
Hide Description A fasting blood sample was obtained for the measurement of HDL-C and LDL-C, allowing the HDL:LDL cholesterol ratio to be calculated. An increase from baseline, that is, a positive value, indicates an improvement in condition.
Time Frame Baseline to EOT (Day 57) or ET
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set: All participants who were randomized, received at least one dose of study medication, and had on-treatment efficacy data. Participants who did not have any relevant post-randomization efficacy data were excluded from the analysis.
Arm/Group Title GWP42003 200 mg/Day Dose GWP42003 400 mg/Day Dose GWP42003 800 mg/Day Dose Placebo
Hide Arm/Group Description:
Participants self-administered one 100 mg GWP42003 capsule twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
Participants self-administered two x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
Participants self-administered four x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
Participants self-administered one, two or four placebo capsules twice daily, for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
Overall Number of Participants Analyzed 7 6 7 5
Mean (Standard Deviation)
Unit of Measure: change in ratio
-0.02  (0.13) -0.00  (0.08) 0.03  (0.09) 0.01  (0.06)
6.Secondary Outcome
Title Change From Baseline To The EOT In Mean Serum Triglyceride Levels
Hide Description A fasting blood sample was obtained for the measurement of serum triglycerides. A reduction from baseline, that is, a negative value, indicates an improvement in condition.
Time Frame Baseline to EOT (Day 57) or ET
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set: All participants who were randomized, received at least one dose of study medication, and had on-treatment efficacy data. Participants who did not have any relevant post-randomization efficacy data were excluded from the analysis.
Arm/Group Title GWP42003 200 mg/Day Dose GWP42003 400 mg/Day Dose GWP42003 800 mg/Day Dose Placebo
Hide Arm/Group Description:
Participants self-administered one 100 mg GWP42003 capsule twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
Participants self-administered two x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
Participants self-administered four x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
Participants self-administered one, two or four placebo capsules twice daily, for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
Overall Number of Participants Analyzed 7 6 7 5
Mean (Standard Deviation)
Unit of Measure: mmol/l
-0.40  (1.05) -0.29  (0.82) -0.50  (1.16) -0.28  (0.39)
Time Frame Day 1 through Day 77
Adverse Event Reporting Description Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
 
Arm/Group Title GWP42003 200 mg/Day Dose GWP42003 400 mg/Day Dose 800 mg GWP42003 Placebo
Hide Arm/Group Description Participants self-administered one x 100 mg GWP42003 capsule twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). Participants self-administered two x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). Participants self-administered four x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). Participants self-administered one, two or four placebo capsules twice daily, for 8 weeks (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]).
All-Cause Mortality
GWP42003 200 mg/Day Dose GWP42003 400 mg/Day Dose 800 mg GWP42003 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
GWP42003 200 mg/Day Dose GWP42003 400 mg/Day Dose 800 mg GWP42003 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/6 (0.00%)   0/7 (0.00%)   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GWP42003 200 mg/Day Dose GWP42003 400 mg/Day Dose 800 mg GWP42003 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/7 (85.71%)   5/6 (83.33%)   7/7 (100.00%)   5/5 (100.00%) 
Ear and labyrinth disorders         
Ear pain  1  0/7 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/5 (0.00%) 
Meniere's disease  1  1/7 (14.29%)  0/6 (0.00%)  0/7 (0.00%)  0/5 (0.00%) 
Gastrointestinal disorders         
Abdominal distension  1  0/7 (0.00%)  1/6 (16.67%)  1/7 (14.29%)  1/5 (20.00%) 
Abdominal pain  1  0/7 (0.00%)  1/6 (16.67%)  1/7 (14.29%)  1/5 (20.00%) 
Abnormal faeces  1  0/7 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/5 (20.00%) 
Change of bowel habit  1  0/7 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/5 (20.00%) 
Constipation  1  0/7 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/5 (20.00%) 
Defaecation urgency  1  0/7 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/5 (0.00%) 
Diarrhoea  1  4/7 (57.14%)  3/6 (50.00%)  5/7 (71.43%)  0/5 (0.00%) 
Dyspepsia  1  0/7 (0.00%)  1/6 (16.67%)  1/7 (14.29%)  0/5 (0.00%) 
Eructation  1  0/7 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/5 (0.00%) 
Flatulence  1  0/7 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/5 (20.00%) 
Frequent bowel movements  1  0/7 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/5 (0.00%) 
Gastritis  1  1/7 (14.29%)  0/6 (0.00%)  0/7 (0.00%)  0/5 (0.00%) 
Gastrointestinal hypermotility  1  0/7 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/5 (0.00%) 
Nausea  1  1/7 (14.29%)  1/6 (16.67%)  0/7 (0.00%)  1/5 (20.00%) 
Vomiting  1  1/7 (14.29%)  0/6 (0.00%)  1/7 (14.29%)  0/5 (0.00%) 
General disorders         
Fatigue  1  1/7 (14.29%)  1/6 (16.67%)  0/7 (0.00%)  0/5 (0.00%) 
Product size issue  1  1/7 (14.29%)  0/6 (0.00%)  0/7 (0.00%)  0/5 (0.00%) 
Immune system disorders         
Seasonal allergy  1  0/7 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  1/5 (20.00%) 
Infections and infestations         
Gastroenteritis  1  0/7 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/5 (0.00%) 
Nasopharyngitis  1  1/7 (14.29%)  1/6 (16.67%)  0/7 (0.00%)  0/5 (0.00%) 
Pharyngitis  1  0/7 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/5 (0.00%) 
Tooth abscess  1  0/7 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/5 (20.00%) 
Tooth infection  1  1/7 (14.29%)  0/6 (0.00%)  0/7 (0.00%)  0/5 (0.00%) 
Upper respiratory tract infection  1  1/7 (14.29%)  1/6 (16.67%)  0/7 (0.00%)  0/5 (0.00%) 
Injury, poisoning and procedural complications         
Fall  1  1/7 (14.29%)  0/6 (0.00%)  0/7 (0.00%)  0/5 (0.00%) 
Investigations         
Aspartate aminotransferase increased  1  1/7 (14.29%)  0/6 (0.00%)  0/7 (0.00%)  0/5 (0.00%) 
Gamma-glutamyltransferase increased  1  1/7 (14.29%)  0/6 (0.00%)  0/7 (0.00%)  0/5 (0.00%) 
Heart sounds abnormal  1  0/7 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/5 (20.00%) 
Platelet count decreased  1  1/7 (14.29%)  0/6 (0.00%)  0/7 (0.00%)  0/5 (0.00%) 
Metabolism and nutrition disorders         
Decreased appetite  1  1/7 (14.29%)  0/6 (0.00%)  1/7 (14.29%)  0/5 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  1/7 (14.29%)  0/6 (0.00%)  0/7 (0.00%)  0/5 (0.00%) 
Back pain  1  0/7 (0.00%)  1/6 (16.67%)  1/7 (14.29%)  0/5 (0.00%) 
Neck pain  1  0/7 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/5 (0.00%) 
Nervous system disorders         
Dizziness  1  0/7 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  1/5 (20.00%) 
Dysgeusia  1  0/7 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/5 (0.00%) 
Headache  1  1/7 (14.29%)  3/6 (50.00%)  2/7 (28.57%)  0/5 (0.00%) 
Lethargy  1  0/7 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/5 (20.00%) 
Poor quality sleep  1  0/7 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/5 (0.00%) 
Psychiatric disorders         
Depressed mood  1  0/7 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/5 (20.00%) 
Renal and urinary disorders         
Pollakiuria  1  0/7 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/5 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  0/7 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/5 (20.00%) 
Dyspnoea  1  0/7 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/5 (20.00%) 
Nasal congestion  1  0/7 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/5 (20.00%) 
Oropharyngeal pain  1  1/7 (14.29%)  0/6 (0.00%)  0/7 (0.00%)  0/5 (0.00%) 
Skin and subcutaneous tissue disorders         
Hyperhidrosis  1  0/7 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/5 (20.00%) 
Pruritus  1  0/7 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/5 (0.00%) 
Rash generalised  1  0/7 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/5 (0.00%) 
Rash maculo-papular  1  0/7 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/5 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
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.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title: Medical Enquires
Organization: GW Research Ltd
Responsible Party: GW Research Ltd
ClinicalTrials.gov Identifier: NCT01284634     History of Changes
Other Study ID Numbers: GWMD09112
2009-017080-41 ( EudraCT Number )
First Submitted: January 26, 2011
First Posted: January 27, 2011
Results First Submitted: December 3, 2013
Results First Posted: January 20, 2014
Last Update Posted: August 8, 2018