Budesonide Effervescent Tablets vs. Viscous Budesonide Suspension vs. Placebo in Eosinophilic Esophagitis

January 20, 2016 updated by: Dr. Falk Pharma GmbH

Double-blind, Double-dummy, Randomized, Placebo-controlled, Phase IIa Study on the Efficacy and Tolerability of a 14-day Treatment With Budesonide Effervescent Tablets vs. Viscous Budesonide Suspension vs. Placebo in Patients With Eosinophilic Esophagitis

The purpose of this study is to assess the efficacy of a low and high dose of a budesonide effervescent tablet and oral viscous budesonide suspension vs. placebo for the induction treatment of active eosinophilic esophagitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 2

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

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Major Inclusion Criteria:

  • Signed informed consent
  • Male or female patients, 18 to 75 years of age
  • Confirmed clinicopathological diagnosis of EoE according to established diagnostic criteria:

(A) Clinical symptoms of esophageal dysfunction (B) Peak eosinophils ≥ 15 in at least 1 high-power field (hpf)

- Active symptomatic and histological EoE at baseline

Major Exclusion Criteria:

  • Clinically and endoscopically suspicion for gastroesophageal reflux disease, achalasia, or sklerodermia
  • Gastroesophageal reflux disease and PPI-responsive esophageal eosinophilia
  • Other clinical 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)
  • Any relevant systemic disease (e.g., AIDS, active tuberculosis)
  • Abnormal hepatic function at screening visit, liver cirrhosis, or portal hypertension
  • Abnormal renal function at screening
  • History of cancer in the last five years (except for non-metastatic cancers, e.g., basalioma)
  • 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
  • Concomitant, or within the 4 weeks prior to screening visit, treatment with systemic therapies for any reason that may affect assessment of primary and secondary endpoints, i.e., systemic glucocorticoids, histamine antagonists, mast cell stabilizers, leukotriene receptor antagonists, biologics, or immunosuppressants
  • Concomitant, or within the 2 weeks prior to screening visit, treatment with topical therapies for any reason that may affect assessment of primary and secondary endpoints, i.e., topical glucocorticoids or inhaled sodium cromoglycate
  • Installation of dietary restrictions within 4 weeks prior to screening visit or during treatment
  • Intake of grapefruit containing food or beverages during the treatment with study medication
  • Known intolerance/hypersensitivity to study drug
  • 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
Placebo Comparator: Placebo
Drug: Placebo
placebo tablet twice daily AND 5ml placebo suspension twice daily
Experimental: Low dose budesonide tablet
Drug: low dose budesonide tablet
1mg budesonide tablet twice daily AND 5ml placebo suspension twice daily
Other Names:
  • BET 1mg BID
Experimental: High dose budesonide tablet
Drug: high dose budesonide tablet
2mg budesonide tablet twice daily AND 5ml placebo suspension twice daily
Other Names:
  • BET 2mg BID
Experimental: High dose budesonide suspension
Drug: high dose budesonide suspension
placebo tablet twice daily AND 5ml [0.4mg budesonide/ml] suspension twice daily
Other Names:
  • BVS 2mg BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of histological remission
Time Frame: 2 weeks (LOCF)
2 weeks (LOCF)
Change in the mean numbers of eos
Time Frame: 2 weeks (LOCF)
2 weeks (LOCF)

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in the mean numbers of eos
Time Frame: 2 weeks (LOCF)
2 weeks (LOCF)

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

June 1, 2011

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

October 29, 2014

First Submitted That Met QC Criteria

October 30, 2014

First Posted (Estimate)

October 31, 2014

Study Record Updates

Last Update Posted (Estimate)

January 21, 2016

Last Update Submitted That Met QC Criteria

January 20, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BUU-2/EEA
  • 2009-016692-29 (EudraCT Number)

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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