Budesonide Versus Mesalazine Versus Placebo in Lymphocytic Colitis

Double-blind, Double-dummy, Randomised, Placebo-controlled, Multi-centre Phase III Study on the Efficacy and Tolerability of a 8-week Treatment With Budesonide vs. Mesalazine vs. Placebo in Patients With Lymphocytic Colitis

The purpose of this study is to determine whether budesonide or mesalazine is more active in the treatment of lymphocytic colitis.

Inclusion Criteria:

• Signed informed consent
• Symptoms and signs of indication of lymphocytic colitis

Exclusion Criteria:

• Infectious diarrhoea,
• Diarrhoea as a result of the presence of other symptomatic organic disease(s) of the gastrointestinal tract or endoscopic-histological findings Celiac disease
• Pregnancy or breast-feeding,
• Participation in an other clinical trial