Pouchitis Trial - Alicaforsen

Atlantic Healthcare is recruiting pouch patients for a Phase 3 trial of alicaforsen enema to treat pouchitis. The trial is a randomised, double-blind, placebo-controlled, safety and efficacy study of alicaforsen enema in patients with active, chronic, antibiotic refractory pouchitis. Patients will receive either 240mg alicaforsen enema or placebo, self-administered daily for six weeks.

The study is looking to understand the proportion of patients with endoscopic remission at week 10, and the proportion of patients with a reduction in relative stool frequency at week 10. Patients will record clinical symptoms associated with pouchitis daily, and will also undergo endoscopic examination of their pouch at the start of the trial and at weeks 6 and 10, with biopsy samples taken where possible. Patients will be monitored for six months or until they next flare, whichever is sooner. The trial will also assess Quality of Life.

Trial centres are across the United States, Canada, Europe and Israel with results expected to be reported in H2/2017. Your nearest UK based centre will be advised once you register your interest.

For further information and to register your interest to participate, visit Atlantic Healthcare’s website at http://www.atlantichc.com/patientinfo.htm.  

What is Pouchitis?
Pouchitis is an inflammatory condition of the ileal pouch that can lead to an increase in frequency of defecation, blood in the stool and urgency to defecate. It may also cause pain or discomfort in the pelvis. It occurs predominantly in patients who previously had ulcerative colitis, but can affect anyone with a pouch. Current treatment is with antibiotics, and you should notice an improvement in symptoms after a few days. [Source: Ileoanal Pouch – IA]