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NCT06596252PHASE3Recruiting

Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE

Dr. Falk Pharma GmbH

Start Date

5/21/2021

Completion Date

3/1/2028

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 clinico-pathological remission in adult patients with active eosinophilic esophagitis.

Eligibility Criteria

Age Range: 18 years to 75 years

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.

Interventions

DRUG

Budesonide

Interested in This Trial?

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Conditions

Eosinophilic Esophagitis

Locations

Dr. Falk Investigational Site

Scottsdale, Arizona 85259

United States

Dr. Falk Investigational Site

Little Rock, Arkansas 72205

United States

Dr. Falk Investigational Site

La Jolla, California 92037

United States

Dr. Falk Investigational Site

Lomita, California 90717

United States

Dr. Falk Investigational Site

San Diego, California 92193

United States

Dr. Falk Investigational Site

Doral, Florida 83706

United States

Dr. Falk Investigational Site

New Port Richey, Florida 34653

United States

Dr. Falk Investigational Site

Boise, Idaho 83706

United States

Dr. Falk Investigational Site

Houma, Louisiana 70363

United States

Dr. Falk Investigational Site

Marrero, Louisiana 70072

United States

Dr. Falk Investigational Site

Boston, Massachusetts 02111

United States

Wyoming

Ann Arbor, Michigan 48109

United States

Dr. Falk Investigational Site

Plymouth, Michigan 55446

United States

Dr. Falk Investigational Site

Wyoming, Michigan 49519

United States

Dr. Falk Investigational Site

Rochester, Minnesota 55905

United States

Dr. Falk Investigational Site

Freehold, New Jersey 07728

United States

Dr. Falk Investigational Site

Jackson, New Jersey 08527

United States

Dr. Falk Investigational Site

New York, New York 10075

United States

Dr. Falk Investigational Site

Chapel Hill, North Carolina 27599-7080

United States

Dr. Falk Investigational Site

Cleveland, Ohio 44195

United States

Dr. Falk Investigational Site

Mentor, Ohio 44060

United States

Wyoming

Philadelphia, Pennsylvania 19104

United States

Dr. Falk Investigational Site

Harlingen, Texas 78550

United States

Dr. Falk Investigational Site

Salt Lake City, Utah 85259

United States

Dr. Falk Investigational Site

Charlottesville, Virginia 22903

United States

Dr. Falk Investigational Site

Lynchburg, Virginia 24502

United States

Department of Gastroenterology, Hospital General de Tomelloso

Tomelloso, 13700

Spain