The purpose of this study is to determine whether budesonide or mesalazine is more active in the treatment of collagenous colitis.
This study will check the reproducibility of the results reported in trials with budesonide in patients with collagenous colitis. Efficacy of mesalazine was never tested in collagenous colitis by placebo-controlled trials. This trial will check the superiority of mesalazine over placebo using the common clinical symptom of collagenous colitis, which is chronic or recurrent non-bloody, watery diarrhea.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
92
Center of digestive diseases
Hamburg, Germany
Rate of clinical remission (<= 3 stools per day) after 8 weeks
Time frame: 8 weeks
Rate of clinical remission (<= 3 stools per day) after 2 weeks
Time frame: 2 weeks
Time to remission
Impact on stool consistency (watery/soft/solid)
Time frame: 8 weeks
Impact on abdominal pain
Time frame: 8 weeks
Impact on patient's general well-being
Time frame: 8 weeks
Effect on histopathology
Time frame: 8 weeks
Severity of diarrhea
Time frame: 8 weeks
QoL
Time frame: 8 weeks
PGA
Time frame: 8 weeks
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