Clinical Trial: Budesonide Versus Mesalazine Versus Placebo in Lymphocytic Colitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 W

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

Detailed Summary:
Sponsor: Dr. Falk Pharma GmbH

Current Primary Outcome: Rate of clinical remission [ Time Frame: 8 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Proportion of patients with histological improvement [ Time Frame: 8 weeks ]

Original Secondary Outcome: Time to resolution of clinical symptoms

Information By: Dr. Falk Pharma GmbH

Dates:
Date Received: September 23, 2010
Date Started: May 2010
Date Completion: June 2017
Last Updated: February 6, 2017
Last Verified: February 2017