Budesonide Versus Mesalazine Versus Placebo in Lymphocytic Colitis

Phase 3CompletedNCT01209208

Dr. Falk Pharma GmbH57 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Lymphocytic Colitis

Interventions

BudesonideDRUG

9 mg per day

MesalamineDRUG

3 g per day

PlaceboOTHER

0 g per day

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Magen-Darm-Zentrum, IKE - Internistische Kooperation Eppendorf

Hamburg, Germany

Outcomes

Primary Outcomes

Rate of clinical remission

Time frame: 8 weeks

Secondary Outcomes

Proportion of patients with histological improvement

Time frame: 8 weeks

Data from ClinicalTrials.gov

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