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Budesonide Versus Mesalazine Versus Placebo in Lymphocytic Colitis

NCT01209208 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2017-07-26

No results posted yet for this study

Summary

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

Conditions

  • Lymphocytic Colitis

Interventions

DRUG

Budesonide

9 mg per day

DRUG

Mesalamine

3 g per day

OTHER

Placebo

0 g per day

Sponsors & Collaborators

  • Dr. Falk Pharma GmbH

    lead INDUSTRY

Principal Investigators

  • Stephan Miehlke, Professor · Magen-Darm-Zentrum, IKE - Internistische Kooperation Eppendorf, Hamburg, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2017-06-30
Completion
2017-06-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01209208 on ClinicalTrials.gov