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Clinical study to demonstrate the same clinical efficacy and tolerability of budesonide orodispersible tablets (taken twice a day compared to once a day) for the treatment of esophagus inflammation in adults
EU CTIS ID: 2024-515229-26-00
What this study is testing
To prove the non-inferiority of 1 x 2 mg/d vs. 2 x 1 mg/d budesonide orodispersible tablets for the induction of histological remission in adult patients with active eosinophilic esophagitis (EoE)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed informed consent
- Man or woman 18 to 75 years of age
- Confirmed diagnosis of eosinophilic esophagitis (EoE)
- Active symptomatic and histological EoE
- At least 4 points in Patient's Global Assessment (PatGA) concerning the severity of EoE symptoms at baseline visit
You likely can't join if
- Gastroesophageal reflux disease (GERD)
- Achalasia, scleroderma esophagus, or systemic sclerosis
- Clinically evident causes for esophageal eosinophilia other than EoE
- Any concomitant esophageal disease and relevant active gastrointestinal disease
- Abnormal laboratory values, presence of or suspected relevant concomitant disease(s), that could affect study-specific assessments and/or their evaluation, or might compromise patient's safety and/or compliance (e.g. severe organic or psychiatric diseases/disorders, infectious diseases associated with clinical signs, liver cirrhosis, portal hypertension, cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease
- History of cancer, gastrointestinal bleeding, esophageal surgery, esophageal dilation procedures or need for an immediate endoscopic intervention due to a stricture
See the full eligibility criteria
- Signed informed consent
- Man or woman 18 to 75 years of age
- Confirmed diagnosis of eosinophilic esophagitis (EoE)
- Active symptomatic and histological EoE
- At least 4 points in Patient's Global Assessment (PatGA) concerning the severity of EoE symptoms at baseline visit
- Gastroesophageal reflux disease (GERD)
- Achalasia, scleroderma esophagus, or systemic sclerosis
- Clinically evident causes for esophageal eosinophilia other than EoE
- Any concomitant esophageal disease and relevant active gastrointestinal disease
- Abnormal laboratory values, presence of or suspected relevant concomitant disease(s), that could affect study-specific assessments and/or their evaluation, or might compromise patient's safety and/or compliance (e.g. severe organic or psychiatric diseases/disorders, infectious diseases associated with clinical signs, liver cirrhosis, portal hypertension, cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease
- History of cancer, gastrointestinal bleeding, esophageal surgery, esophageal dilation procedures or need for an immediate endoscopic intervention due to a stricture
- Diagnosis of chickenpox, herpes zoster, or measles within the last 3 months prior to baseline
- Treatment with medication, that could compromise/influence the effects of the study treatment, assessment of the endpoints and/or patients' safety, during or within too narrow timeframe of the clinical trial (e.g. immunosuppressants, CYP3A4 inhibitors, live vaccination, non-stable treatment with proton pump inhibitors)
- Exiting or intended pregnancy or breast-feeding
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
- Canada
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland; Canada; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.