Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE
Recruiting now · Phase 3
Conditions studied: Eosinophilic Esophagitis
In brief
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.
Key facts
- Study ID
- NCT06596252
- Run by
- Dr. Falk Pharma GmbH
- People needed
- 308
- Starts
- 2021-05-21
- Expected to finish
- 2028-03-01
- Last updated by the study team
- 2026-07-10
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Department of Gastroenterology, Hospital General de Tomelloso — Tomelloso, Spain (enrolling)
- Dr. Falk Investigational Site — Little Rock, Arkansas, United States (enrolling)
- Dr. Falk Investigational Site — La Jolla, California, United States (enrolling)
- Wyoming — Philadelphia, Pennsylvania, United States (enrolling)
- Dr. Falk Investigational Site — Harlingen, Texas, United States (enrolling)
- Dr. Falk Investigational Site — Salt Lake City, Utah, United States (enrolling)
- Dr. Falk Investigational Site — Lynchburg, Virginia, United States (enrolling)
- Dr. Falk Investigational Site — Scottsdale, Arizona, United States (enrolling)
- Dr. Falk Investigational Site — San Diego, California, United States (enrolling)
- Dr. Falk Investigational Site — Doral, Florida, United States (enrolling)
- Dr. Falk Investigational Site — New Port Richey, Florida, United States (enrolling)
- Dr. Falk Investigational Site — Boise, Idaho, United States (enrolling)
- Dr. Falk Investigational Site — Boston, Massachusetts, United States (enrolling)
- Wyoming — Ann Arbor, Michigan, United States (enrolling)
- Dr. Falk Investigational Site — Plymouth, Michigan, United States (enrolling)
- Dr. Falk Investigational Site — Wyoming, Michigan, United States (enrolling)
- Dr. Falk Investigational Site — Rochester, Minnesota, United States (enrolling)
- Dr. Falk Investigational Site — Freehold, New Jersey, United States (enrolling)
- Dr. Falk Investigational Site — New York, New York, United States (enrolling)
- Dr. Falk Investigational Site — Chapel Hill, North Carolina, United States (enrolling)
- Dr. Falk Investigational Site — Cleveland, Ohio, United States (enrolling)
- Dr. Falk Investigational Site — Mentor, Ohio, United States (enrolling)
- Dr. Falk Investigational Site — Lomita, California, United States
- Dr. Falk Investigational Site — Houma, Louisiana, United States
- Dr. Falk Investigational Site — Marrero, Louisiana, United States
Full record on ClinicalTrials.gov
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