The purpose of the study is to obtain a first clinical assessment of the safety of dersalazine sodium in ulcerative colitis patients with mild to moderate disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Dersalazine sodium 2400 mg daily
Mesalazine 2400 mg daily
Placebo matching active and experimental treatments
Investigational site 11
Kortrijk, Belgium
Investigational site 1
Leuven, Belgium
Proportion of patients with AEs of severe intensity or AEs leading to treatment withdrawal
Time frame: 7, 14, 21, 28, 56 days
Mayo index
Time frame: 28 days
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Investigational site 12
Budapest, Hungary
Investigational site 10
Eger, Hungary
Investigational site 9
Miskolc, Hungary
Investigational site 8
Székesfehérvár, Hungary
Investigational site 7
Vác, Hungary
Investigational site 18
Košice, Slovakia
Investigational site 20
Košice, Slovakia
Investigational site 16
Malacky, Slovakia
...and 12 more locations