NL-OMON50028已完成2 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 - BUU-5/EEA
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 9
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 17（—）
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
- •- Negative pregnancy test in female patients of childbearing potential
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, 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
- •- 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
- •- Upper gastrointestinal bleeding within 8 weeks prior to screening endoscopy
- •- Existing or intended pregnancy or breast-feeding
研究者
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