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CompletedNCT02434029EOS-1Updated Feb 3, 2017

Budesonide Orodispersible Tablet vs. Placebo in Active Eosinophilic Esophagitis

A Phase 3 interventional study of Budesonide 1mg orodispersible tablet twice daily and Placebo orodispersible tablet twice daily in Eosinophilic Esophagitis, sponsored by Dr. Falk Pharma GmbH. Completed at 1 site in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-02-03.

Sponsored by Dr. Falk Pharma GmbH · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study summary

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.

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Conditions studied

  • Eosinophilic Esophagitis
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In context

Esophagitis

322 studies on the registry are indexed under Esophagitis; 38 are open to participants now.

This study's enrollment of 88 is above the median of 66 across 215 interventional studies indexed under Esophagitis.

Browse Esophagitis studies →

Lead sponsor

Dr. Falk Pharma GmbH is the lead sponsor of 38 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
88 participants (actual)

Study arms

  • 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

Interventions

  • DrugBudesonide 1mg orodispersible tablet twice daily
  • DrugPlacebo orodispersible tablet twice daily
06

What researchers measure

Primary outcomes

  1. Rate of clinico-pathological remission

    Time frame: 6 weeks

Secondary outcomes

  1. Rate of patients with histological remission

    Time frame: 6 weeks

  2. Rate of patients with resolutions of symptoms measured by numerical rating score of symptoms

    Time frame: week 6

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Study locations

1 site
  • Center for Digestive Diseases Eppendorf
    Hamburg, 20249, Germany
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References and documents

Publications

  • Straumann A, Lucendo AJ, Miehlke S, Vieth M, Schlag C, Biedermann L, Vaquero CS, Ciriza de Los Rios C, Schmoecker C, Madisch A, Hruz P, Hayat J, von Arnim U, Bredenoord AJ, Schubert S, Mueller R, Greinwald R, Schoepfer A, Attwood S; International EOS-2 Study Group. Budesonide Orodispersible Tablets Maintain Remission in a Randomized, Placebo-Controlled Trial of Patients With Eosinophilic Esophagitis. Gastroenterology. 2020 Nov;159(5):1672-1685.e5. doi: 10.1053/j.gastro.2020.07.039. Epub 2020 Jul 25. PubMed 32721437 ↗
  • Lucendo AJ, Miehlke S, Schlag C, Vieth M, von Arnim U, Molina-Infante J, Hartmann D, Bredenoord AJ, Ciriza de Los Rios C, Schubert S, Bruckner S, Madisch A, Hayat J, Tack J, Attwood S, Mueller R, Greinwald R, Schoepfer A, Straumann A; International EOS-1 Study Group. Efficacy of Budesonide Orodispersible Tablets as Induction Therapy for Eosinophilic Esophagitis in a Randomized Placebo-Controlled Trial. Gastroenterology. 2019 Jul;157(1):74-86.e15. doi: 10.1053/j.gastro.2019.03.025. Epub 2019 Mar 26. PubMed 30922997 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02434029
Lead sponsor
Dr. Falk Pharma GmbH
Responsible party
Sponsor
First posted
May 5, 2015
Start date
Nov 11, 2015
Primary completion
Aug 4, 2016
Completion
Oct 4, 2016
Last update
Feb 3, 2017

Study contacts

Ralph Mueller, PhD
study director · Dr. Falk Pharma GmbH

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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