2024-515229-26-00招募中3 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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 234
- 试验地点
- 23
- 主要终点
- Proportion of patients with histological remission
研究概览
简要总结
To prove the non-inferiority of 1 x 2 mg/d vs. 2 x 1 mg/d budesonide orodispersible tablets for the induction of histological remission in adult patients with active eosinophilic esophagitis (EoE)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
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
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 gastrointestinal 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
结局指标
主要结局
Proportion of patients with histological remission
Proportion of patients with histological remission
次要结局
- Change in the peak eos/mm2 hpf from baseline to week 6 (LOCF)
- Change in the severity of dysphagia
- Change in the severity of odynophagia
- Change of overall severity of EoE symptoms
- Change in the total weekly Eosinophilic Esophagitis Activity Index
研究者
CTIS – Scientific Request
Scientific
Dr. Falk Pharma GmbH
研究点 (23)
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