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

Phase 3

Completed

• Conditions: Eosinophilic Esophagitis
• Interventions: Drug: Placebo orodispersible tablet twice daily; Drug: Budesonide 0.5mg orodispersible tablet twice daily; Drug: Budesonide 1mg orodispersible tablet twice daily

• Registration Number: NCT02493335
• Lead Sponsor: Dr. Falk Pharma GmbH

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-07
• Study First Submitted QC: 2015-07-07
• Study First Posted: 2015-07-09
• Study Start: 2016-01-15
• Primary Completion: 2018-11-28
• Study Completion: 2020-12-11
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-06
• Last Update Posted: 2021-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

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
• Clinico-pathological remission of 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.

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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 baseline visit,
• Existing or intended pregnancy or breast-feeding.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo orodispersible tablet twice daily	Placebo orodispersible tablet twice daily	Placebo orodispersible tablet twice daily
Budesonide 0.5mg orodispersible tablet twice daily	Budesonide 0.5mg orodispersible tablet twice daily	Budesonide 0.5mg orodispersible tablet twice daily
Budesonide 1mg orodispersible tablet twice daily	Budesonide 1mg orodispersible tablet twice daily	Budesonide 1mg orodispersible tablet twice daily

Primary Outcome Measures

Name	Time	Method
Rate of patients free of treatment failure after 48 weeks of treatment.	48 weeks

Secondary Outcome Measures

Name	Time	Method
Rate of patients with histological relapse	48 weeks
Rate of patients with clinical relapse	48 weeks

Trial Locations

Locations (1)

Center for Digestive Diseases Eppendorf; 🇩🇪 Hamburg, Germany