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 Research Ltd
ClinicalTrials.gov Identifier:
NCT01284634
First received: January 26, 2011
Last updated: September 9, 2014
Last verified: September 2014
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


  Baseline Characteristics
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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.
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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
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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


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  Limitations and Caveats
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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
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