NCT05488405已完成2 期
Open-label, Monocentric Phase IIa Pilot Study Evaluating the Efficacy and Tolerability of a 4-week Treatment With Mesalazine Oral Suspension in Patients With Active Eosinophilic Esophagitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Proportion of patients with histological remission
研究概览
简要总结
Pilot study to assess a mesalazine oral suspension in active eosinophilic esophagitis
详细描述
This is an open-label, monocentric exploratory phase IIa pilot study, which serves to evaluate the efficacy, safety, and tolerability of treatment with mesalazine oral suspension for the treatment of active eosinophilic esophagitis (EoE).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Male or female patients, 18 to 75 years of age
- •Confirmed clinico-pathological diagnosis of eosinophilic esophagitis (EoE) according to established diagnostic criteria
- •Negative pregnancy test in females of childbearing potential
排除标准
- •Other causes for esophageal eosinophilia
- •Clinical and endoscopic signs of gastroesophageal reflux disease (GERD)
- •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 known or suspicion for relevant infectious diseases associated with clinical signs,
- •Known intolerance/hypersensitivity/resistance to the IMP or excipients or drugs of similar chemical structure or pharmacological profile
- •Existing or intended pregnancy or breast-feeding
研究组 & 干预措施
Mesalamine treatment
Experimental
Treatment of patient with mesalamine oral suspension
干预措施: Mesalamine Oral Product (Drug)
结局指标
主要结局
Proportion of patients with histological remission
时间窗: 4 weeks
Assessment of remission of histological signs of EoE
次要结局
- Proportion of patients with histological response(4 weeks)
- Proportion of patients with improvement of symptoms(4 weeks)
研究者
研究点 (1)
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