Study to Assess the Effect of Cannabidiol on Liver Fat Levels in Subjects With Fatty Liver Disease.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GW Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier:
NCT01284634
First received: January 26, 2011
Last updated: December 3, 2013
Last verified: December 2013
Results First Received: December 3, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Fatty Liver
Intervention: Drug: Cannabidiol

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
200 mg GWP42003 Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
400 mg GWP42003 Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
800 mg GWP42003 Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
Placebo Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.

Participant Flow:   Overall Study
    200 mg GWP42003     400 mg GWP42003     800 mg GWP42003     Placebo  
STARTED     7     6     7     5  
COMPLETED     6     6     5     4  
NOT COMPLETED     1     0     2     1  
Adverse Event                 1                 0                 2                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
200 mg GWP42003 Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first 30 minutes before breakfast [fasted] and the second 30 minutes for the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003 per day.
400 mg GWP42003 Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes for the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003 per day.
800 mg GWP42003 Subjects self-administered four x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes for the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003 per day.
Placebo Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
Total Total of all reporting groups

Baseline Measures
    200 mg GWP42003     400 mg GWP42003     800 mg GWP42003     Placebo     Total  
Number of Participants  
[units: participants]
  7     6     7     5     25  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     6     6     7     5     24  
>=65 years     1     0     0     0     1  
Age  
[units: years]
Mean ± Standard Deviation
  40.69  ± 14.62     49.08  ± 7.72     46.90  ± 12.57     50.41  ± 18.41     46.39  ± 13.29  
Gender  
[units: participants]
         
Female     5     2     2     4     13  
Male     2     4     5     1     12  
Region of Enrollment  
[units: participants]
         
United Kingdom     7     6     7     5     25  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline to the End of Treatment in Mean % Liver Triglyceride Levels   [ Time Frame: After 56 days of treatment ]

2.  Secondary:   Change From Baseline to the End of Treatment it Mean Serum Total Cholesterol Levels   [ Time Frame: After 56 days of treatment ]

3.  Secondary:   Change From Baseline to the End of Treatment in Mean Serum High Density Lipoprotein (HDL)-Cholesterol(C) Levels   [ Time Frame: After 56 days of treatment ]

4.  Secondary:   Change From Baseline to the End of Treatment in Mean Serum Low Density Lipoprotein (LDL)-Cholesterol(C) Levels   [ Time Frame: After 56 days of treatment ]

5.  Secondary:   Change From Baseline to the End of Treatment it the Mean Serum HDL:LDL Cholesterol Ratio   [ Time Frame: After 56 days of treatment ]

6.  Secondary:   Change From Baseline to the End of Treatment in Mean Serum Triglyceride Levels   [ Time Frame: After 56 days of treatment ]

7.  Secondary:   Change From Baseline to the End of Treatment in Mean Fasting Plasma Glucose Levels   [ Time Frame: After 56 days of treatment ]

8.  Secondary:   Change From Baseline to the End of Treatment in Mean Body Mass Index (BMI)   [ Time Frame: After 56 days of treatment ]

9.  Secondary:   Change From Baseline to the End of Treatment in Mean Body Weight   [ Time Frame: After 56 days of treatment ]

10.  Secondary:   Change From Baseline to the End of Treatment in Mean Waist-to-hip Ratio   [ Time Frame: After 56 days of treatment ]

11.  Secondary:   Change From Baseline to the End of Treatment in Mean Neck Measurement   [ Time Frame: After 56 days of treatment ]

12.  Secondary:   Change From Baseline to the End of Treatment in Mean Waist Measurement   [ Time Frame: After 56 days of treatment ]

13.  Secondary:   Change From Baseline to the End of Treatment in Mean Hip Measurement   [ Time Frame: After 56 days of treatment ]

14.  Secondary:   Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Chest/Pectoral)   [ Time Frame: After 56 days of treatment ]

15.  Secondary:   Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Midaxillary)   [ Time Frame: After 56 days of treatment ]

16.  Secondary:   Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Triceps)   [ Time Frame: After 56 days of treatment ]

17.  Secondary:   Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Subscapular)   [ Time Frame: After 56 days of treatment ]

18.  Secondary:   Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Abdomen)   [ Time Frame: After 56 days of treatment ]

19.  Secondary:   Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Suprailiac)   [ Time Frame: After 56 days of treatment ]

20.  Secondary:   Change From Baseline to the End of Treatment in Mean Skin-fold Thickness (Thigh)   [ Time Frame: After 56 days of treatment ]

21.  Secondary:   Change From Baseline to the End of Treatment in Mean Total Skin-fold Thickness   [ Time Frame: After 56 days of treatment ]

22.  Secondary:   Change From Baseline to the End of Treatment in Mean Visceral Abdominal Fat   [ Time Frame: After 56 days of treatment ]

23.  Secondary:   Change From Baseline to the End of Treatment in Mean Subcutaneous Abdominal Fat   [ Time Frame: After 56 days of treatment ]

24.  Secondary:   Change From Baseline to the End of Treatment in Mean Total Abdominal Fat   [ Time Frame: After 56 days of treatment ]

25.  Secondary:   Change From Baseline to the End of Treatment in Mean Internal Non-abdominal Fat   [ Time Frame: After 56 days of treatment ]

26.  Secondary:   Change From Baseline to the End of Treatment in Mean Subcutaneous Non-abdominal Fat   [ Time Frame: After 56 days of treatment ]

27.  Secondary:   Change From Baseline to the End of Treatment in Mean Total Non-abdominal Fat   [ Time Frame: After 56 days of treatment ]

28.  Secondary:   Change From Baseline to the End of Treatment in Mean Total Internal Fat   [ Time Frame: After 56 days of treatment ]

29.  Secondary:   Change From Baseline to the End of Treatment in Mean Total Subcutaneous Fat   [ Time Frame: After 56 days of treatment ]

30.  Secondary:   Change From Baseline to the End of Treatment in Mean Total Fat   [ Time Frame: After 56 days of treatment ]

31.  Secondary:   Change From Baseline to the End of Treatment in Mean Abdominal Adiposity   [ Time Frame: After 56 days of treatment ]

32.  Secondary:   Change From Baseline to the End of Treatment in Mean Total Fat as a Percentage of Body Weight   [ Time Frame: After 56 days of treatment ]

33.  Secondary:   Change From Baseline to the End of Treatment in Mean Fasting Serum Insulin   [ Time Frame: After 56 days of treatment ]

34.  Secondary:   Incidence of Adverse Events (AEs) as a Measure of Patient Safety   [ Time Frame: From 0 -10 weeks (study duration) ]


  Serious Adverse Events


  Other Adverse Events
  Hide Other Adverse Events

Time Frame All adverse events occurring from the study onset to follow-up (up to 73 days) were collected.
Additional Description All adverse events occurring during the study were reported on the running logs at the back of the study case report form.

Frequency Threshold
Threshold above which other adverse events are reported   1%  

Reporting Groups
  Description
200 mg GWP42003 Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first 30 minutes before breakfast [fasted] and the second 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003 per day.
400 mg GWP42003 Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003 per day.
800 mg GWP42003 Subjects self-administered four x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003 per day.
Placebo Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.

Other Adverse Events
    200 mg GWP42003     400 mg GWP42003     800 mg GWP42003     Placebo  
Total, other (not including serious) adverse events          
# participants affected / at risk     6/7     5/6     7/7     5/5  
Ear and labyrinth disorders          
Ear pain † 1        
# participants affected / at risk     0/7 (0.00%)     0/6 (0.00%)     1/7 (14.29%)     0/5 (0.00%)  
Meniere's disease † 1        
# participants affected / at risk     1/7 (14.29%)     0/6 (0.00%)     0/7 (0.00%)     0/5 (0.00%)  
Gastrointestinal disorders          
Abdominal distension † 1        
# participants affected / at risk     0/7 (0.00%)     1/6 (16.67%)     1/7 (14.29%)     1/5 (20.00%)  
Abdominal pain † 1        
# participants affected / at risk     0/7 (0.00%)     1/6 (16.67%)     1/7 (14.29%)     1/5 (20.00%)  
Abnormal faeces † 1        
# participants affected / at risk     0/7 (0.00%)     0/6 (0.00%)     0/7 (0.00%)     1/5 (20.00%)  
Change of bowel habit † 1        
# participants affected / at risk     0/7 (0.00%)     0/6 (0.00%)     0/7 (0.00%)     1/5 (20.00%)  
Constipation † 1        
# participants affected / at risk     0/7 (0.00%)     0/6 (0.00%)     0/7 (0.00%)     1/5 (20.00%)  
Defaecation urgency † 1        
# participants affected / at risk     0/7 (0.00%)     0/6 (0.00%)     1/7 (14.29%)     0/5 (0.00%)  
Diarrhoea † 1        
# participants affected / at risk     4/7 (57.14%)     3/6 (50.00%)     5/7 (71.43%)     0/5 (0.00%)  
Dyspepsia † 1        
# participants affected / at risk     0/7 (0.00%)     1/6 (16.67%)     1/7 (14.29%)     0/5 (0.00%)  
Eructation † 1        
# participants affected / at risk     0/7 (0.00%)     0/6 (0.00%)     1/7 (14.29%)     0/5 (0.00%)  
Flatulence † 1        
# participants affected / at risk     0/7 (0.00%)     0/6 (0.00%)     0/7 (0.00%)     1/5 (20.00%)  
Frequent bowel movements † 1        
# participants affected / at risk     0/7 (0.00%)     0/6 (0.00%)     1/7 (14.29%)     0/5 (0.00%)  
Gastritis † 1        
# participants affected / at risk     1/7 (14.29%)     0/6 (0.00%)     0/7 (0.00%)     0/5 (0.00%)  
Gastrointestinal hypermotility † 1        
# participants affected / at risk     0/7 (0.00%)     1/6 (16.67%)     0/7 (0.00%)     0/5 (0.00%)  
Nausea † 1        
# participants affected / at risk     1/7 (14.29%)     1/6 (16.67%)     0/7 (0.00%)     1/5 (20.00%)  
Vomiting † 1        
# participants affected / at risk     1/7 (14.29%)     0/6 (0.00%)     1/7 (14.29%)     0/5 (0.00%)  
General disorders          
Fatigue † 1        
# participants affected / at risk     1/7 (14.29%)     1/6 (16.67%)     0/7 (0.00%)     0/5 (0.00%)  
Product size issue † 1        
# participants affected / at risk     1/7 (14.29%)     0/6 (0.00%)     0/7 (0.00%)     0/5 (0.00%)  
Immune system disorders          
Seasonal allergy † 1        
# participants affected / at risk     0/7 (0.00%)     1/6 (16.67%)     0/7 (0.00%)     1/5 (20.00%)  
Infections and infestations          
Gastroenteritis † 1        
# participants affected / at risk     0/7 (0.00%)     0/6 (0.00%)     1/7 (14.29%)     0/5 (0.00%)  
Nasopharyngitis † 1        
# participants affected / at risk     1/7 (14.29%)     1/6 (16.67%)     0/7 (0.00%)     0/5 (0.00%)  
Pharyngitis † 1        
# participants affected / at risk     0/7 (0.00%)     0/6 (0.00%)     1/7 (14.29%)     0/5 (0.00%)  
Tooth abscess † 1        
# participants affected / at risk     0/7 (0.00%)     0/6 (0.00%)     0/7 (0.00%)     1/5 (20.00%)  
Tooth infection † 1        
# participants affected / at risk     1/7 (14.29%)     0/6 (0.00%)     0/7 (0.00%)     0/5 (0.00%)  
Upper respiratory tract infection † 1        
# participants affected / at risk     1/7 (14.29%)     1/6 (16.67%)     0/7 (0.00%)     0/5 (0.00%)  
Injury, poisoning and procedural complications          
Fall † 1        
# participants affected / at risk     1/7 (14.29%)     0/6 (0.00%)     0/7 (0.00%)     0/5 (0.00%)  
Investigations          
Aspartate aminotransferase increased † 1        
# participants affected / at risk     1/7 (14.29%)     0/6 (0.00%)     0/7 (0.00%)     0/5 (0.00%)  
Gamma-glutamyltransferase increased † 1        
# participants affected / at risk     1/7 (14.29%)     0/6 (0.00%)     0/7 (0.00%)     0/5 (0.00%)  
Heart sounds abnormal † 1        
# participants affected / at risk     0/7 (0.00%)     0/6 (0.00%)     0/7 (0.00%)     1/5 (20.00%)  
Platelet count decreased † 1        
# participants affected / at risk     1/7 (14.29%)     0/6 (0.00%)     0/7 (0.00%)     0/5 (0.00%)  
Metabolism and nutrition disorders          
Decreased appetite † 1        
# participants affected / at risk     1/7 (14.29%)     0/6 (0.00%)     1/7 (14.29%)     0/5 (0.00%)  
Musculoskeletal and connective tissue disorders          
Arthralgia † 1        
# participants affected / at risk     1/7 (14.29%)     0/6 (0.00%)     0/7 (0.00%)     0/5 (0.00%)  
Back pain † 1        
# participants affected / at risk     0/7 (0.00%)     1/6 (16.67%)     1/7 (14.29%)     0/5 (0.00%)  
Neck pain † 1        
# participants affected / at risk     0/7 (0.00%)     0/6 (0.00%)     1/7 (14.29%)     0/5 (0.00%)  
Nervous system disorders          
Dizziness † 1        
# participants affected / at risk     0/7 (0.00%)     0/6 (0.00%)     1/7 (14.29%)     1/5 (20.00%)  
Dysgeusia † 1        
# participants affected / at risk     0/7 (0.00%)     0/6 (0.00%)     1/7 (14.29%)     0/5 (0.00%)  
Headache † 1        
# participants affected / at risk     1/7 (14.29%)     3/6 (50.00%)     2/7 (28.57%)     0/5 (0.00%)  
Lethargy † 1        
# participants affected / at risk     0/7 (0.00%)     0/6 (0.00%)     0/7 (0.00%)     1/5 (20.00%)  
Poor quality sleep † 1        
# participants affected / at risk     0/7 (0.00%)     1/6 (16.67%)     0/7 (0.00%)     0/5 (0.00%)  
Psychiatric disorders          
Depressed mood † 1        
# participants affected / at risk     0/7 (0.00%)     0/6 (0.00%)     0/7 (0.00%)     1/5 (20.00%)  
Renal and urinary disorders          
Pollakiuria † 1        
# participants affected / at risk     0/7 (0.00%)     0/6 (0.00%)     1/7 (14.29%)     0/5 (0.00%)  
Respiratory, thoracic and mediastinal disorders          
Cough † 1        
# participants affected / at risk     0/7 (0.00%)     0/6 (0.00%)     0/7 (0.00%)     1/5 (20.00%)  
Dyspnoea † 1        
# participants affected / at risk     0/7 (0.00%)     0/6 (0.00%)     0/7 (0.00%)     1/5 (20.00%)  
Nasal congestion † 1        
# participants affected / at risk     0/7 (0.00%)     0/6 (0.00%)     0/7 (0.00%)     1/5 (20.00%)  
Oropharyngeal pain † 1        
# participants affected / at risk     1/7 (14.29%)     0/6 (0.00%)     0/7 (0.00%)     0/5 (0.00%)  
Skin and subcutaneous tissue disorders          
Hyperhidrosis † 1        
# participants affected / at risk     0/7 (0.00%)     0/6 (0.00%)     0/7 (0.00%)     1/5 (20.00%)  
Pruritus † 1        
# participants affected / at risk     0/7 (0.00%)     1/6 (16.67%)     0/7 (0.00%)     0/5 (0.00%)  
Rash generalised † 1        
# participants affected / at risk     0/7 (0.00%)     0/6 (0.00%)     1/7 (14.29%)     0/5 (0.00%)  
Rash maculo-papular † 1        
# participants affected / at risk     0/7 (0.00%)     0/6 (0.00%)     1/7 (14.29%)     0/5 (0.00%)  
Events were collected by systematic assessment
1 Term from vocabulary, medDRA 13.1



  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information