Study to compare Alicaforsen with placebo in patients with Pouchitis
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
Atlantic Pharmaceuticals Limited
Duration of Study in the UK
1 years, 6 months, 0 days
A Phase III, multi-centre, double-blind randomized controlled study in participants with chronic antibiotic refractory pouchitis.
The purpose of this study is to determine the effect of alicaforsen enema on endoscopic healing and symptoms associated with pouchitis in participants with active antibiotic refractory pouchitis. Pouchitis is the name given to the inflammation participants are experiencing in their pouch.
The study will also evaluate the safety of alicaforsen enema, and how well study participants tolerate the enema
A total of approximately 138 patients will participate in this study at approximately 40 sites throughout UK, Europe (including Israel) and North America. Approximately 24 participants will be enrolled in the UK.
69 participants will receive 240 mg alicaforsen enema, once nightly; 69 participants will receive matching placebo enema and the study will last for about 7 months. This includes up to 3 weeks for the screening period, a 6 week treatment period using the study enema followed by a 20 week observation period after stopping using the enema.
Participants would be asked to sign a consent form and would be screened to determine their eligibility to take part in the study. Only patients who have chronic antibiotic refractory pouchitis and meet other inclusion criteria would be eligible for this study.
Some of the procedures/assessments that the participants would undergo include the following:
• Questions about any current or previous illnesses, including smoking
history, details of any medication currently being taking will be asked
• Endoscopic assessment of the pouch
• Urine samples will be collected for urinalysis
• Stool samples for faecal calprotectin will be collected
• Diary cards will be utilised daily to record subjects’ symptoms (bowel
frequency, degree of urgency, incontinence, abdominal pain/cramps, rectal
It is possible that participants taking part in this study may find no benefit to them, but the information obtained from this study will help in future to improve the treatment of people with Chronic Antibiotic Refractory Pouchitis.
Atlantic Pharmaceuticals Limited is sponsor of the study.
London - Westminster Research Ethics Committee
Date of REC Opinion
30 Nov 2015