Maintenance of Remission With Budesonide Orodispersible Tablets vs. Placebo in Eosinophilic Esophagitis

Study Purpose

The purpose of this study is to prove the superiority of a 48-weeks treatment with budesonide orodispersible tablets versus placebo for the maintenance of clinico-pathological remission in patients with eosinophilic esophagitis.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

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.

- Clinico-pathological remission of EoE, - A documented trial with proton pump inhibitors (PPIs) in order to rule out PPI-responsive esophageal eosinophilia, - Negative pregnancy test in females of childbearing potential at baseline visit.

Exclusion Criteria:

- Clinical and endoscopic signs of gastroesophageal reflux disease (GERD), - History of abnormal results in case of an optionally performed pH-monitoring of the distal esophagus, - Patients with PPI-responsive esophageal eosinophilia.

- 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), - 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 8 weeks prior to screening visit, - Upper gastrointestinal bleeding within 8 weeks prior to baseline visit, - Existing or intended pregnancy or breast-feeding.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02493335
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Dr. Falk Pharma GmbH
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Ralph Mueller, PhD
Principal Investigator Affiliation	Dr. Falk Pharma GmbH
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Active, not recruiting
Countries	Germany
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Eosinophilic Esophagitis

Arms & Interventions

Arms

Experimental: Budesonide 0.5mg orodispersible tablet twice daily

Budesonide 0.5mg orodispersible tablet twice daily

Experimental: Budesonide 1mg orodispersible tablet twice daily

Budesonide 1mg orodispersible tablet twice daily

Placebo Comparator: Placebo orodispersible tablet twice daily

Placebo orodispersible tablet twice daily

Interventions

Drug: - Budesonide 0.5mg orodispersible tablet twice daily

Drug: - Budesonide 1mg orodispersible tablet twice daily

Drug: - Placebo orodispersible tablet twice daily

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Center for Digestive Diseases Eppendorf, Hamburg, Germany

Status

Address

Center for Digestive Diseases Eppendorf

Hamburg, , 20249

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