Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE

Recruiting Phase 3 Interventional Study
Eosinophilic Esophagitis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
308 (estimated)
Sponsor
Dr. Falk Pharma GmbH · Industry
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About This Trial

The purpose of this study is to prove the non-inferiority of a 6-weeks treatment with 1 mg budesonide orodispersible tablets BID versus 2 mg budesonide orodispesible tabletss for the induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis.

Trial Locations
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Eligibility Criteria
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 * Negative pregnancy test in females o…
Contacts

Sarah Burrack, Dr.

004976115140

zentrale@drfalkpharma.de

CONTACT