EUCTR2017-003737-29-ES
Active, not recruiting
Phase 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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Active eosinophilic esophagitis and maintenance of remission in eosinophilic esophagitis
- Sponsor
- Dr. Falk Pharma GmbH
- Enrollment
- 75
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
- •\- 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
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, 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 4 weeks prior to screening endoscopy, or need for an immediate endoscopic intervention due to a stricture
Outcomes
Primary Outcomes
Not specified
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