EUCTR2020-001314-37-AT进行中（未招募）1 期
Double-blind, double-dummy, randomized, parallel-group, non-inferiority phase III trial on the efficacy and tolerability of 2 mg once daily vs. 1 mg twice daily budesonide orodispersible tablets for induction of histological remission in adults with eosinophilic esophagitis
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 242
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,
- •- Man or woman 18 to 75?years of age,
- •- Confirmed diagnosis of eosinophilic esophagitis (EoE)
- •- Active symptomatic and histological EoE
- •- At least 4?points in Patient’s Global Assessment (PatGA) concerning the severity of EoE symptoms 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 196
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 46
排除标准
- •- gastroesophageal reflux disease (GERD),
- •- Achalasia, scleroderma esophagus, or systemic sclerosis,
- •- clinically evident causes for esophageal eosinophilia other than EoE
- •- Any concomitant esophageal disease and relevant active gastro-intestinal disease
- •- abnormal laboratory values, presence of or suspected relevant concomitant disease(s), that could affect study-specific assessments and/or their evaluation, or might compromise patient's safety and/or compliance (e.g. severe organic or psychiatric diseases/disorders, infectious diseases associated with clinical signs, liver cirrhosis, portal hypertension, cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease
- •- History of cancer, gastrointestinal bleeding, esophageal surgery, esophageal dilation procedures or need for an immediate endoscopic intervention due to a stricture
- •- Diagnosis of chickenpox, herpes zoster, or measles within the last 3 months prior to baseline,
- •- Treatment with medication, that could compromise/influence the effects of the study treatment, assessment of the endpoints and/or patients' safety, during or within too narrow timeframe of the clinical trial (e.g. immunosuppressants, CYP3A4 inhibitors, live vaccination, non-stable treatment with proton pump inhibitors)
- •- exiting or intended pregnancy or breast-feeding
研究者
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