Budesonide Versus Mesalazine Versus Placebo in Lymphocytic Colitis

Phase 3

Completed

• Conditions: Lymphocytic Colitis
• Interventions: Other: Placebo; Drug: Mesalamine; Drug: Budesonide

• Registration Number: NCT01209208
• Lead Sponsor: Dr. Falk Pharma GmbH

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-09-23
• Study First Submitted QC: 2010-09-24
• Study First Posted: 2010-09-27
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-25
• Last Update Posted: 2017-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C	Placebo	-
B	Mesalamine	Mesalazine
A	Budesonide	Budesonide

Primary Outcome Measures

Name	Time	Method
Rate of clinical remission	8 weeks

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with histological improvement	8 weeks

Trial Locations

Locations (1)

Magen-Darm-Zentrum, IKE - Internistische Kooperation Eppendorf; 🇩🇪 Hamburg, Germany