EUCTR2017-003737-29-NLActive, not recruitingPhase 1
Double-blind, randomized, placebo-controlled, Phase II/III trial on the efficacy and tolerability of treatment with budesonide oral suspension vs. placebo in children and adolescents with eosinophilic esophagitis - Budesonide oral suspension vs. placebo in pediatric eosinophilic esophagitis
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Dr. Falk Pharma GmbH
- Enrollment
- 75
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
- •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 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 ecquivalence 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 treatemtn (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
Investigators
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