Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (one of the treatment groups receives medication without active substance), phase II/III study on the efficacy and tolerability of oral budesonide suspension in comparison with placebo in children and adolescents with eosinophilic esophagitis
- Conditions
- Active eosinophilic esophagitis and maintenance of remission in eosinophilic esophagitisMedDRA version: 20.1 Level: LLT Classification code 10064220 Term: Eosinophilic esophagitis System Organ Class: 100000004856Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2017-003737-29-GB
- Lead Sponsor
- Dr. Falk Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 75
Inclusion criteria for DB-treatment phase:
- Signed informed consent
- Male or female patients, =2 to <18 years of age
- Confirmed clinico-pathological diagnosis of EoE according to established diagnostic criteria
- Clinically and histologically active EoE
- Indication for treatment with a steroid
- Negative pregnancy test in female patients of childbearing potential
Are the trial subjects under 18? yes
Number of subjects for this age range: 75
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria for DB treatment phase:
- Erosive 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, symptomatic Helicobacter pylori associated gastritis or any planned Helicobacter pylori eradication, oropharyngeal or esophageal bacterial, viral, or untreated or inadequately treated fungal infection [candida esophagitis])
- Any known relevant infectious diseases (e.g., AIDS defining disease, active tuberculosis, hepatitis B, or hepatitis C)
- Diabetes mellitus
- If careful medical monitoring is not ensured: cardiovascular disease, hypertension, osteoporosis, active peptic ulcer disease, glaucoma, cataract, or infection
- History of cancer in the last five years
- History of esophageal surgery at any time or of esophageal dilation
procedures within the last 12 weeks prior to screening endoscopy,
presence of an acute obstruction and/or need for an immediate
endoscopic intervention due to a stricture
- In case of treatment equivalence of either steroid, PPI or dietary
treatment: Patient/ parents wish to install a new or changed dietary or
PPI approach
- Patient with high disease burden at screening and/or any patient with
need for immediate treatment (incl. due to severe dysphagia,
dehydration, loss of weight),
- Upper gastrointestinal bleeding within 8 weeks prior to screening endoscopy
- Existing or intended pregnancy or breast-feeding
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: Double-blind phase:<br> To prove superior efficacy of budesonide oral suspension compared to placebo in children and adolescents with eosinophilic esophagitis (EoE)<br> ;<br> Secondary Objective: Double-blind phase:<br> To further assess efficacy of budesonide oral suspension in children and adolescents with eosinophilic esophagitis (EoE)<br><br> ;<br> Primary end point(s): Double-blind phase:<br> Rate of patients with pathological remission and clinical response at DB week 12<br> ;Timepoint(s) of evaluation of this end point: week 12
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: week 12;<br> Secondary end point(s): Double-blind phase:<br> - Rate of patients with histological remission at DB week 12<br> - Rate of patients with clinical response at DB week 12<br>