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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

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

ArmDescriptionAssigned Intervention
Experimental
Arm A 		Budesonide 2 mg orodispersible tablet once daily
  • Drug: Budesonide
    Twice daily intake of the tablet 30 min after a meal
Active Comparator
Arm B 		Budesonide 1 mg orodispersible tablet twice daily
  • Drug: Budesonide
    Twice daily intake of the tablet 30 min after a meal
Experimental
OLE 		Open label extension with Budesonide 0.5 mg or 1 mg orodispersible tablet twice daily
  • Drug: Budesonide
    Twice daily intake of the tablet 30 min after a meal

Recruiting Locations

Dr. Falk Investigational Site
Scottsdale, Arizona 85259

Dr. Falk Investigational Site
Little Rock, Arkansas 72205

Dr. Falk Investigational Site
La Jolla, California 92037
Contact:
858-824-4151

Dr. Falk Investigational Site
San Diego, California 92193

Dr. Falk Investigational Site
Doral, Florida 83706

Dr. Falk Investigational Site
New Port Richey, Florida 34653

Dr. Falk Investigational Site
Boise, Idaho 83706
Contact:
208-813-6505

Dr. Falk Investigational Site
Boston, Massachusetts 02111
Contact:
617-804-6767

Wyoming
Ann Arbor, Michigan 48109

Dr. Falk Investigational Site
Plymouth, Michigan 55446
Contact:
612-870-5599

Dr. Falk Investigational Site
Wyoming, Michigan 49519

Dr. Falk Investigational Site
Rochester, Minnesota 55905
Contact:
507-284-2511

Dr. Falk Investigational Site
Freehold, New Jersey 07728
Contact:
504-934-8424

Dr. Falk Investigational Site
New York, New York 10075

Dr. Falk Investigational Site
Chapel Hill, North Carolina 27599-7080
Contact:
919-966-2996

Dr. Falk Investigational Site
Cleveland, Ohio 44195
Contact:
216-444-7691

Dr. Falk Investigational Site
Mentor, Ohio 44060

Wyoming
Philadelphia, Pennsylvania 19104

Dr. Falk Investigational Site
Harlingen, Texas 78550
Contact:
956-377-4371

Dr. Falk Investigational Site
Salt Lake City, Utah 85259
Contact:
480-301-6292

Dr. Falk Investigational Site
Lynchburg, Virginia 24502

More Details

Status
Recruiting
Sponsor
Dr. Falk Pharma GmbH

Study Contact

Sarah Burrack, Dr.
004976115140
zentrale@drfalkpharma.de

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.