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Maintenance of Remission With Budesonide Orodispersible Tablets vs. Placebo in Eosinophilic Esophagitis

NCT02493335 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2021-10-07

No results posted yet for this study

Summary

The purpose of this study is to prove the superiority of a 48-weeks treatment with budesonide orodispersible tablets versus placebo for the maintenance of clinico-pathological remission in patients with eosinophilic esophagitis.

Conditions

  • Eosinophilic Esophagitis

Interventions

DRUG

Budesonide 0.5mg orodispersible tablet twice daily

DRUG

Budesonide 1mg orodispersible tablet twice daily

DRUG

Placebo orodispersible tablet twice daily

Sponsors & Collaborators

  • Dr. Falk Pharma GmbH

    lead INDUSTRY

Principal Investigators

  • Ralph Mueller, PhD · Dr. Falk Pharma GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-01-15
Primary Completion
2018-11-28
Completion
2020-12-11

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 NCT02493335 on ClinicalTrials.gov