Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE
Purpose
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.
Condition
- Eosinophilic Esophagitis
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential Assignment
- Intervention Model Description
- Double-blind, controlled interventional study phase followed by an optional open-label extension phase
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm A |
Budesonide 2 mg orodispersible tablet once daily |
|
|
Active Comparator Arm B |
Budesonide 1 mg orodispersible tablet twice daily |
|
|
Experimental OLE |
Open label extension with Budesonide 0.5 mg or 1 mg orodispersible tablet twice daily |
|
Recruiting Locations
Dr. Falk Investigational Site
Scottsdale, Arizona 85259
Scottsdale, Arizona 85259
Dr. Falk Investigational Site
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
Dr. Falk Investigational Site
La Jolla, California 92037
La Jolla, California 92037
Contact:
858-824-4151
858-824-4151
Dr. Falk Investigational Site
San Diego, California 92193
San Diego, California 92193
Dr. Falk Investigational Site
Doral, Florida 83706
Doral, Florida 83706
Dr. Falk Investigational Site
New Port Richey, Florida 34653
New Port Richey, Florida 34653
Dr. Falk Investigational Site
Boise, Idaho 83706
Boise, Idaho 83706
Contact:
208-813-6505
208-813-6505
Dr. Falk Investigational Site
Boston, Massachusetts 02111
Boston, Massachusetts 02111
Contact:
617-804-6767
617-804-6767
Wyoming
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
Dr. Falk Investigational Site
Plymouth, Michigan 55446
Plymouth, Michigan 55446
Contact:
612-870-5599
612-870-5599
Dr. Falk Investigational Site
Wyoming, Michigan 49519
Wyoming, Michigan 49519
Dr. Falk Investigational Site
Rochester, Minnesota 55905
Rochester, Minnesota 55905
Contact:
507-284-2511
507-284-2511
Dr. Falk Investigational Site
Freehold, New Jersey 07728
Freehold, New Jersey 07728
Contact:
504-934-8424
504-934-8424
Dr. Falk Investigational Site
New York, New York 10075
New York, New York 10075
Dr. Falk Investigational Site
Chapel Hill, North Carolina 27599-7080
Chapel Hill, North Carolina 27599-7080
Contact:
919-966-2996
919-966-2996
Dr. Falk Investigational Site
Cleveland, Ohio 44195
Cleveland, Ohio 44195
Contact:
216-444-7691
216-444-7691
Dr. Falk Investigational Site
Mentor, Ohio 44060
Mentor, Ohio 44060
Wyoming
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
Dr. Falk Investigational Site
Harlingen, Texas 78550
Harlingen, Texas 78550
Contact:
956-377-4371
956-377-4371
Dr. Falk Investigational Site
Salt Lake City, Utah 85259
Salt Lake City, Utah 85259
Contact:
480-301-6292
480-301-6292
Dr. Falk Investigational Site
Lynchburg, Virginia 24502
Lynchburg, Virginia 24502
More Details
- Status
- Recruiting
- Sponsor
- Dr. Falk Pharma GmbH