EUCTR2017-003737-29-PT
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
- last year
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
- •\- 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
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 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
Outcomes
Primary Outcomes
Not specified
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Active, not recruiting
Phase 1
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 esophagitisEUCTR2017-003737-29-NLDr. Falk Pharma GmbH75
Active, not recruiting
Phase 1
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 esophagitisActive 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]EUCTR2017-003737-29-ESDr. Falk Pharma GmbH75