Trial | NCT01209208  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    57
The purpose of this study is to determine whether budesonide or mesalazine is more active in the treatment of lymphocytic colitis.
Study Started
May 31
2010
Primary Completion
Jun 30
2017
Study Completion
Jun 30
2017
Last Update
Jul 26
2017

Drug Budesonide

9 mg per day

Drug Mesalamine

3 g per day

Other Placebo

0 g per day

A Experimental

Budesonide

B Experimental

Mesalazine

C Placebo Comparator

Criteria 

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
No Results Posted