Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE
NCT ID: NCT06596252
Last Updated: 2026-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
308 participants
INTERVENTIONAL
2021-05-21
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm A
Budesonide 2 mg orodispersible tablet once daily
Budesonide
Twice daily intake of the tablet 30 min after a meal
Arm B
Budesonide 1 mg orodispersible tablet twice daily
Budesonide
Twice daily intake of the tablet 30 min after a meal
Interventions
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Budesonide
Twice daily intake of the tablet 30 min after a meal
Eligibility Criteria
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Inclusion Criteria
* 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
* Negative pregnancy test in females of childbearing potential at baseline visit.
Exclusion Criteria
* 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, hepatitis B or C),
* 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 4 weeks prior to screening visit, or need for an immediate endoscopic intervention due to a stricture
* Upper gastrointestinal bleeding within 8 weeks prior to baseline visit,
* Existing or intended pregnancy or breast-feeding.
18 Years
75 Years
ALL
No
Sponsors
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Dr. Falk Pharma GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Alfredo J Lucendo, MD, PhD
Role: STUDY_DIRECTOR
Department of Gastroenterology, Hospital General de Tomelloso, Spain
Locations
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Dr. Falk Investigational Site
La Jolla, California, United States
Dr. Falk Investigational Site
Lomita, California, United States
Dr. Falk Investigational Site
Boise, Idaho, United States
Dr. Falk Investigational Site
Houma, Louisiana, United States
Dr. Falk Investigational Site
Marrero, Louisiana, United States
Dr. Falk Investigational Site
Boston, Massachusetts, United States
Dr. Falk Investigational Site
Rochester, Minnesota, United States
Dr. Falk Investigational Site
Freehold, New Jersey, United States
Dr. Falk Investigational Site
Jackson, New Jersey, United States
Dr. Falk Investigational Site
Chapel Hill, North Carolina, United States
Dr. Falk Investigational Site
Cleveland, Ohio, United States
Dr. Falk Investigational Site
Harlingen, Texas, United States
Dr. Falk Investigational Site
Salt Lake City, Utah, United States
Department of Gastroenterology, Hospital General de Tomelloso
Tomelloso, , Spain
Countries
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Central Contacts
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Facility Contacts
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Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Other Identifiers
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2024-515229-26-00
Identifier Type: CTIS
Identifier Source: secondary_id
2020-001314-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BUL-8/EEA
Identifier Type: -
Identifier Source: org_study_id
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