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Budesonide for Induction of Remission in Incomplete Microscopic Colitis

NCT02142634 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2020-07-22

No results posted yet for this study

Summary

The purpose of this study is to demonstrate the efficacy of budesonide for the treatment of active incomplete microscopic colitis.

Conditions

  • Incomplete Microscopic Colitis

Interventions

DRUG

Budesonide granules 9 mg

per day

DRUG

Placebo granules

per day

Sponsors & Collaborators

  • Dr. Falk Pharma GmbH

    lead INDUSTRY

Principal Investigators

  • Andreas Münch, MD · University Hospital of Linköping, Dept. of Gastroenterology and Hepatology

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
2014-05-31
Primary Completion
2020-02-29
Completion
2020-02-29

Countries

  • Germany
  • Sweden

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 NCT02142634 on ClinicalTrials.gov