EUCTR2014-001484-12-NL进行中（未招募）1 期
Double-blind, randomized, placebo-controlled, phase III trial on the efficacy and tolerability of a 6-week treatment with budesonide effervescent tablets vs. placebo for induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis - Induction of remission with budesonide effervescent tablets vs. placebo in eosinophilic esophagitis
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
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
- •- Signed informed consent,
- •- Male or female patients, 18 to 75 years of age,
- •- Confirmed clinico-pathological diagnosis of EoE according to established diagnostic criteria ,
- •- Active symptomatic and histological EoE,
- •- A documented trial with proton pump inhibitors (PPIs) in order to rule out PPI-responsive esophageal eosinophilia,
- •- Negative pregnancy test in females of childbearing potential at baseline visit
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •- Clinical signs (i.e., acid regurgitation and/or heart burn) and endoscopic signs (at least Los Angeles Classification of Esophagitis Grade A) of gastroesophageal reflux disease (GERD),
- •- History of abnormal results in case of an optionally performed pH monitoring of the distal esophagus,
- •- Patients with PPI-responsive esophageal eosinophilia
- •- 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 fungal infection [candida esophagitis]),
- •- Any relevant systemic disease (e.g., AIDS, active tuberculosis),
- •- If careful medical monitoring is not ensured: cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease, glaucoma, cataract, or infection,
- •- Liver cirrhosis or portal hypertension,
- •- History of cancer in the last five years,
- •- History of esophageal surgery at any time or of esophageal dilation procedures within the last 8 weeks prior to screening visit,
- •- Upper gastrointestinal bleeding within 8 weeks prior to screening visit,
- •- Existing or intended pregnancy or breast-feeding.
研究者
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