GWID10160: GWP42003 IN THE SYMPTOMATIC TREATMENT OF ULCERATIVE COLITIS

• Research type

  Research Study

• Full title

  A randomised, double-blind, placebo-controlled parallel group, pilot study of GWP42003 in the symptomatic treatment of ulcerative colitis

• IRAS ID

  83841

• Contact name

  Peter Irving

• Sponsor organisation

  GW Pharma Ltd

• Eudract number

  2011-003208-19

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This study is being sponsored by GW Pharma Ltd as a pilot study in order to determine the efficacy and safety of a new medicine, GWP42003, in subjects with ulcerative colitis. This is a multicentre, randomised, double-blind, placebo-controlled, parallel group pilot study. There will be two parallel groups of subjects; 1) 150mg to 250mg GWP42003 and 2) placebo, with a treatment duration of approximately 10 weeks as well as a one week baseline period and one week follow-up. There will be 6 study visits for this study, 5 of which will be conducted at clinic.The two treatment groups will be randomised at a 1:1 ratio.In order to be eligible for enrolment in this study, subjects will need to be aged 18 years and above, have diagnosed ulcerative colitis for which they have been treated with a stable dose of 5-ASA for a minimum of two weeks.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  11/EM/0286

• Date of REC Opinion

  28 Oct 2011

• REC opinion

  Further Information Favourable Opinion