TP05 In Active UC
Research type
Research Study
Full title
A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC)
IRAS ID
131463
Contact name
Ailsa HART
Contact email
Sponsor organisation
Tillotts Pharma AG
Eudract number
2013-000366-11
ISRCTN Number
n/a
Research summary
Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Also, to see if TP05, will be as effective in treating the symptoms of Ulcerative Colitis, as well as that Asacol does (whether TP05 is non-inferior to Asacol). Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. The TP0503 study is a multicenter, international study wit in total 800 patients over 15 countries. The study will be concluded in Q1 of 2016.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
13/SC/0364
Date of REC Opinion
30 Aug 2013
REC opinion
Further Information Favourable Opinion