The purpose of this study is to prove the superiority of a 48-weeks treatment with 3.2 g/day delayed-release phosphatidylcholine (LT-02) versus placebo for the maintenance of remission in patients with ulcerative colitis (UC)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
LT-02 1.6g twice daily AND mesalamine PLACEBO three-times daily
LT-02 PLACEBO twice daily AND mesalamine PLACEBO three-times daily
LT-02 PLACEBO twice daily AND mesalamine 500mg three-times daily
Agaplesion Markus-Krankenhaus
Frankfurt a.M., Germany
Percentage of patients who are relapse-free and are not a treatment failure
Time frame: 48 weeks
Mean change from baseline in the total mDAI
Time frame: 48 weeks
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