Status:
RECRUITING
Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE
Lead Sponsor:
Dr. Falk Pharma GmbH
Conditions:
Eosinophilic Esophagitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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 clin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
308 Patients enrolled
Trial Details
Trial ID
NCT06596252
Start Date
May 21 2021
End Date
June 1 2026
Last Update
July 25 2025
Active Locations (12)
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1
Dr. Falk Investigational Site
La Jolla, California, United States, 92037
2
Dr. Falk Investigational Site
Lomita, California, United States, 90717
3
Dr. Falk Investigational Site
Houma, Louisiana, United States, 70363
4
Dr. Falk Investigational Site
Marrero, Louisiana, United States, 70072