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Budesonide Capsules vs. Mesalazine Granules vs. Placebo in Collagenous Colitis

NCT00450086 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2014-05-19

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 collagenous colitis.

Conditions

  • Collagenous Colitis

Interventions

DRUG

Budesonide

9 mg per day

DRUG

Mesalazine

3 g per day

DRUG

Placebo

0 g per day

Sponsors & Collaborators

  • Dr. Falk Pharma GmbH

    lead INDUSTRY

Principal Investigators

  • Stephan Miehlke, Professor · Center for digestive diseases

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2011-06-30
Completion
2011-08-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

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 NCT00450086 on ClinicalTrials.gov