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

InDex Pharmaceuticals AB0 sites120 target enrollmentOctober 14, 2011

Overview

No summary available.

Registry

who.int

Start Date

October 14, 2011

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Male or female \= 18 years of age.
•2\. Well established diagnosis of moderate to moderately severe chronic active UC with a CAI score \=9, an endoscopic score \=2, not responding adequately to currently available therapies and potential candidates for colectomy. Previously tried therapies should include:
•At least one treatment course with mesalazine; at least 2\.4 g/day for at least 4 weeks, or at least one treatment course with similar drugs in this class.
•At least one full dose treatment course of corticosteroids (which can be the treatment of a recent relapse), with up to 0\.75 mg/kg as a starting dose or highest dose according to local clinical practice.
•At least one treatment course of azathioprine or mercaptopurine of at least 3 months duration and/or at least one adequate treatment course of an anti\-TNF alpha.
•Any unsuccessful combination treatment of the above.
•May have tried treatment with cyclosporine and/or tacrolimus or any other
•immunosuppressant/immunomodulating agent.
•Intolerance to any of the above medications corresponds to inadequate response.
•3\. Patients shall at study enrolment be on an accumulated stable tolerable GCS dose

•1\. Patients with suspicion of Crohn’s enterocolitis, ischaemic colitis, radiation colitis, diverticular disease associated colitis, as well as microscopic colitis should be excluded. Patients with disease limited to the rectum (ulcerative proctitis) should also be excluded.
•2\. History or presence of a clinically significant cardiovascular, hepatic, renal,
•haematological, endocrine, neurological, psychiatric disease, or immune compromised state as judged relevant by the investigator.
•3\. Patients with acute fulminant UC and/or signs of systemic toxicity to an extent that
•requires immediate surgical action.
•4\. History or presence of any colonic malignancy and/or dysplasia.
•5\. Concomitant treatment with cyclosporine, tacrolimus, anti\-TNFs or similar immunosuppressants/immunomodulators is not allowed and should have been
•discontinued 4 weeks before enrolment. Patients who fail the wash\-out criteria can
•undergo wash\-out and be re\-screened at a later time point.
•6\. Treatment with antibiotics or Non\-Steroidal Anti\-Inflammatory Drugs (NSAIDs) within two weeks before enrolment.