Once Daily Versus Twice Daily Budesonide Orodispersible Tablets for Induction of Remission in EoE
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Budesonide.
- Who it may be relevant to
- Registry conditions: Eosinophilic Esophagitis. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Double-blind, Randomized, Non-inferiority Phase III Trial on the Efficacy and Tolerability of 2 mg Once Daily vs. 1 mg Twice Daily Budesonide Orodispersible Tablets in Adults With Eosinophilic Esophagitis
Overview
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.
Interventions
- Drug Budesonide
Twice daily intake of the tablet 30 min after a meal
Primary outcome measures
- Proportion of patients in histological remission [Time frame: 6 weeks]
Secondary outcome measures (1)
- Proportion of patients in clinical remission [Time frame: 6 weeks]
Eligibility 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
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 26 centers
- Dr. Falk Investigational Site — Scottsdale
- Dr. Falk Investigational Site — Little Rock
- Dr. Falk Investigational Site — La Jolla
- Dr. Falk Investigational Site — Lomita
- Dr. Falk Investigational Site — San Diego
- Dr. Falk Investigational Site — Doral
- Dr. Falk Investigational Site — New Port Richey
- Dr. Falk Investigational Site — Boise
- … and 18 more centers
Spain · 1 center
- Department of Gastroenterology, Hospital General de Tomelloso — Tomelloso
Identifiers
NCT: NCT06596252 · BUL-8/EEA · 2024-515229-26-00 · 2020-001314-37