Budesonide Orodispersible Tablet vs. Placebo in Active Eosinophilic Esophagitis (EOS-1)

February 2, 2017 updated by: Dr. Falk Pharma GmbH

Double-blind, Randomized, Placebo-controlled, Phase III Trial on the Efficacy and Tolerability of a 6-week Treatment With Budesonide Effervescent Tablets vs. Placebo for Induction of Clinico-pathological Remission in Adult Patients With Active Eosinophilic Esophagitis

The purpose of this study is to prove the superiority of a 6-weeks treatment with budesonide effervescent tablets versus placebo for the induction of clinico-pathological remission in patients with acute eosinophilic esophagitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20249
        • Center for Digestive Diseases Eppendorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed informed consent,
  • Male or female patients, 18 to 75 years of age,
  • Confirmed clinico-pathological diagnosis of eosinophilic esophagitis (EoE) according to established diagnostic criteria
  • Active symptomatic and histological EoE,
  • A documented trial with proton pump inhibitors (PPIs) in order to rule out PPI-responsive esophageal eosinophilia,
  • Negative pregnancy test in females of childbearing potential at baseline visit.

Exclusion Criteria:

  • Clinical and endoscopic signs of gastroesophageal reflux disease (GERD),
  • History of abnormal results in case of an optionally performed pH-monitoring of the distal esophagus,
  • Patients with PPI-responsive esophageal eosinophilia
  • Achalasia, scleroderma esophagus, or systemic sclerosis,
  • Other clinically evident causes than EoE for esophageal eosinophilia,
  • Any concomitant esophageal disease and relevant gastro-intestinal disease (celiac disease, inflammatory bowel disease, oropharyngeal or esophageal bacterial, viral, or fungal infection [candida esophagitis]),
  • Any relevant systemic disease (e.g., AIDS, active tuberculosis),
  • If careful medical monitoring is not ensured: cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease, glaucoma, cataract, or infection,
  • Liver cirrhosis or portal hypertension,
  • History of cancer in the last five years,
  • History of esophageal surgery at any time or of esophageal dilation procedures within the last 8 weeks prior to screening visit,
  • Upper gastrointestinal bleeding within 8 weeks prior to screening visit,
  • Existing or intended pregnancy or breast-feeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Budesonide
Budesonide 1mg orodispersible tablet twice daily
Drug: Budesonide 1mg orodispersible tablet twice daily
Placebo Comparator: Placebo
Placebo orodispersible tablet twice daily
Drug: Placebo orodispersible tablet twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of clinico-pathological remission
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of patients with histological remission
Time Frame: 6 weeks
6 weeks
Rate of patients with resolutions of symptoms measured by numerical rating score of symptoms
Time Frame: week 6
week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Falk Pharma GmbH

Investigators

  • Study Director: Ralph Mueller, PhD, Dr. Falk Pharma GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2015

Primary Completion (Actual)

August 4, 2016

Study Completion (Actual)

October 4, 2016

Study Registration Dates

First Submitted

April 30, 2015

First Submitted That Met QC Criteria

May 4, 2015

First Posted (Estimate)

May 5, 2015

Study Record Updates

Last Update Posted (Estimate)

February 3, 2017

Last Update Submitted That Met QC Criteria

February 2, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BUL-1/EEA
  • 2014-001484-12 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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