The purpose of this study is to compare two different dosing regimens of phosphatidylcholine versus placebo for the induction of remission in ulcerative colitis patients non-responsive to standard mesalamine treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
468
Agaplesion Markus-Krankenhaus, 1st Dept. of Medicine
Frankfurt a.M., Germany
Rate of clinical remission
Time frame: 12 weeks
Rate of patients with clinical improvement
Time frame: 12 weeks
Time to first resolution of symptoms
Time frame: 12 weeks
Number of stools per week
Time frame: 12 weeks
Number of days with urgency per week
Time frame: 12 weeks
Rate of mucosal healing
Time frame: 12 weeks
Rate of histologic remission
Time frame: 12 weeks
Physician's global assessment at final visit
Time frame: 12 weeks
Quality of life
Time frame: 12 weeks
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