A randomised, partially-blind, placebo-controlled, pilot, dose-ranging study to assess the effect of cannabidiol (CBD) on liver fat levels in subjects with fatty liver disease.

GW Pharma Ltd.0 sites25 target enrollmentMarch 17, 2010

Overview

No summary available.

Registry

who.int

Start Date

March 17, 2010

End Date

July 13, 2012

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•Subject is willing and able to give informed consent for participation in the study
•Subject is aged 18 years or above
•Subjects with a liver fat content of equal to or above 5% as measured by MRI/MRS or biopsy within two months of screening or willing to undergo an MRI/MRS scan at Visit 1to confirm a liver fat content of equal to or above 5%
•In the opinion of the investigator, no changes in levels of exercise for four weeks and diet (as assessed by the physical activity questionnaire and food frequency questionnaire) prior to the start of treatment and subject agrees to keep stable for the duration of the study
•Subject is able (in the investigator’s opinion) and willing to comply with all study requirements
•Subject is willing for his or her name to be notified to the responsible authorities for participation in this study, as applicable
•Subject is willing to allow his or her primary care practitioner and consultant, if appropriate, to be notified of participation in the study
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1\.2 Adults (18\-64 years) yes

•Clinical diagnosis or treatment for Type I / II diabetes
•Subject has received an unapproved IMP within the 30 days prior to the screening visit
•Currently receiving a prohibited medication and unwilling to stop for 14 days prior to the screening visit and for the duration of the study
•Currently using or has used recreational cannabis, medicinal cannabis or cannabinoid medications (including Sativex®), within one month prior to study entry and unwilling to abstain for the duration for the study
•Any known or suspected history of:
•\- alcohol or substance abuse
•\- epilepsy or recurrent seizures
•Any known or suspected history of major depression sufficient to require treatment or disrupt ordinary life (excluding episodes of reactive depression – in the opinion of the investigator)
•Clinically significant cardiac, renal or hepatic impairment in the opinion of the investigator
•Known history of Hepatitis B or C