A Randomised, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of Topical Alicaforsen Enema in Subjects with Active, Chronic, Antibiotic Refractory Primary Idiopathic Pouchitis
29th January 2016 - ongoing
Status: In Recruitment
Specialism: Lower GI.
Surgical treatment of ulcerative colitis usually involves removal of the entire colon. Restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) has become a part of standard surgical treatment for subjects with ulcerative colitis (UC). Despite advances in medical therapy, approximately 30% of subjects with UC eventually require an IPAA. Pouchitis, a nonspecific inflammatory condition at the ileal pouch reservoir, is the most common long-term complication in subjects with IPAA which significantly
affects subjects’ quality of life. While the majority of subjects with pouchitis respond favorably to antibiotic therapy, particularly at initial stages of the disease, some subjects develop pouchitis refractory to regular antibiotic treatment, and alternative therapies are required. There are currently no licensed treatments for pouchitis.
The proposed study is a double-blind, placebo controlled, randomized design, with patients evenly allocated to the two arms (alicaforsen and placebo). Study treatment will be administered as “add-on” therapy. The objective of the study is to demonstrate the superiority of alicaforsen over placebo, and the study has been powered to demonstrate a 30% treatment difference (based on response rates of 50% vs 20%; alicaforsen vs placebo).
|Dr Gordon Moran||Dr Moran did his undergraduate medical training at University of Malta Medical School and was awarded an MD in 1999. He completed his basic postgraduate training at St. Luke's Hospital in Malta and gained membership of the Royal College of Physicians of…|
|Dr Sunil Samuel|