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

NCT06596252

RecruitingPhase 3

Sponsor: Dr. Falk Pharma GmbH

Conditions: Eosinophilic Esophagitis

Interventions: Budesonide

Countries: United States, Spain

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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 of childbearing potential at baseline visit.

Exclusion Criteria:

* Clinical and endoscopic signs of gastroesophageal reflux disease (GERD),
* 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.
Locations (27)
  • Scottsdale, Arizona, United States
  • Little Rock, Arkansas, United States
  • La Jolla, California, United States
  • Lomita, California, United States
  • San Diego, California, United States
  • Doral, Florida, United States
  • New Port Richey, Florida, United States
  • Boise, Idaho, United States
  • Houma, Louisiana, United States
  • Marrero, Louisiana, United States
  • Boston, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • Plymouth, Michigan, United States
  • Wyoming, Michigan, United States
  • Rochester, Minnesota, United States
  • Freehold, New Jersey, United States
  • Jackson, New Jersey, United States
  • New York, New York, United States
  • Chapel Hill, North Carolina, United States
  • Cleveland, Ohio, United States
  • Mentor, Ohio, United States
  • Philadelphia, Pennsylvania, United States
  • Harlingen, Texas, United States
  • Salt Lake City, Utah, United States
  • Charlottesville, Virginia, United States
  • Lynchburg, Virginia, United States
  • Tomelloso, Spain