Effect & Safety of Kappaproct as an add on treatment in UC patients

• Research type

  Research Study

• Full title

  A placebo-controlled, double-blind, randomised study to assess the efficacy and safety of Kappaproct as an add-on to current practice in chronic active treatment refractory ulcerative colitis patients

• IRAS ID

  85785

• Contact name

  Christopher Hawkey

• Sponsor organisation

  InDex Pharmaceuticals AB

• Eudract number

  2011-003130-14

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Ulcerative Colitis (UC) is a disease characterised by chronic inflammation of the rectal and colonic mucosa. Hallmark clinical signs are diarrhea and bleeding, the disease is recurrent and the underlying cause of UC is not understood. This study is a placebo-controlled, double-blind, randomised study to assess the efficacy and safety of Kappaproct as an add-on to current practice in chronic active treatment refractory ulcerative colitis patients. The study population will be chronic active ulcerative colitis patients who are no longer responding adequately to standard therapies and who are potential candidates for colectomy. Kappaproct/placebo will be add-on treatment allowing all included patients to be on concomitant medication, as well as mandatory steroids at inclusion, throughout the study.120 eligible patients will be randomly assigned in a 2:1 allocation to receive two doses of Kappaproct at 30 mg, or placebo, at week 0 and 4. Kappaproct/placebo will be administered proximally to the site of inflammation, or in the transverse section of the colon in the event of extensive colitis or pancolitis, using a spray catheter during endoscopy.The primary endpoint is the induction of clinical remission at week 12.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  11/EM/0309

• Date of REC Opinion

  6 Oct 2011

• REC opinion

  Further Information Favourable Opinion