Actively Recruiting
Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE
Led by Dr. Falk Pharma GmbH · Updated on 2026-04-27
308
Participants Needed
26
Research Sites
301 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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 such as 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
AI-Screening
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Trial Site Locations
Total: 26 locations
1
Dr. Falk Investigational Site
Scottsdale, Arizona, United States, 85259
Not Yet Recruiting
2
Dr. Falk Investigational Site
Little Rock, Arkansas, United States, 72205
Actively Recruiting
3
Dr. Falk Investigational Site
La Jolla, California, United States, 92037
Actively Recruiting
4
Dr. Falk Investigational Site
Lomita, California, United States, 90717
Withdrawn
5
Dr. Falk Investigational Site
San Diego, California, United States, 92193
Not Yet Recruiting
6
Dr. Falk Investigational Site
Doral, Florida, United States, 83706
Actively Recruiting
7
Dr. Falk Investigational Site
New Port Richey, Florida, United States, 34653
Actively Recruiting
8
Dr. Falk Investigational Site
Boise, Idaho, United States, 83706
Actively Recruiting
9
Dr. Falk Investigational Site
Houma, Louisiana, United States, 70363
Actively Recruiting
10
Dr. Falk Investigational Site
Marrero, Louisiana, United States, 70072
Actively Recruiting
11
Dr. Falk Investigational Site
Boston, Massachusetts, United States, 02111
Actively Recruiting
12
Wyoming
Ann Arbor, Michigan, United States, 48109
Not Yet Recruiting
13
Dr. Falk Investigational Site
Wyoming, Michigan, United States, 49519
Actively Recruiting
14
Dr. Falk Investigational Site
Rochester, Minnesota, United States, 55905
Actively Recruiting
15
Dr. Falk Investigational Site
Freehold, New Jersey, United States, 07728
Actively Recruiting
16
Dr. Falk Investigational Site
Jackson, New Jersey, United States, 08527
Actively Recruiting
17
Dr. Falk Investigational Site
New York, New York, United States, 10075
Actively Recruiting
18
Dr. Falk Investigational Site
Chapel Hill, North Carolina, United States, 27599-7080
Actively Recruiting
19
Dr. Falk Investigational Site
Cleveland, Ohio, United States, 44195
Actively Recruiting
20
Dr. Falk Investigational Site
Mentor, Ohio, United States, 44060
Not Yet Recruiting
21
Wyoming
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
22
Dr. Falk Investigational Site
Harlingen, Texas, United States, 78550
Actively Recruiting
23
Dr. Falk Investigational Site
Salt Lake City, Utah, United States, 85259
Actively Recruiting
24
Dr. Falk Investigational Site
Charlottesville, Virginia, United States, 22903
Not Yet Recruiting
25
Dr. Falk Investigational Site
Lynchburg, Virginia, United States, 24502
Not Yet Recruiting
26
Department of Gastroenterology, Hospital General de Tomelloso
Tomelloso, Spain, 13700
Actively Recruiting
Research Team
S
Sarah Burrack, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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