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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 12/16/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Jeffrey Alexander, M.D.

Contact us for the latest status

Contact information:

Mariah Robran CCRP

(507) 266-3595

Robran.Mariah@mayo.edu

More information

Publications

Publications are currently not available