EUCTR2017-003737-29-PT进行中（未招募）1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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