NCT02873468招募中2 期
Randomized, Double-blind, Multicentric, Parallel, National, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Three Doses of Florence Oral Suspension in Adults With Eosinophilic Esophagitis
EMS1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2021年4月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Proportion of participants presenting a histological response, defined as the presence of ≤ 6 eosinophils/high-power field, at the end of treatment.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of three doses of Florence oral suspension on changes of eosinophilic infiltration in esophageal biopsies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed consent;
- •Participants aged 18 years or more;
- •Participants diagnosed with eosinophilic esophagitis, defined as:
- •Presence of symptoms of esophageal dysfunction intermittently or continuously during previous week to the screening visit;
- •Eosinophilic esophageal inflammation with ≥ 15 eosinophils/high-power field, in the screening endoscopy;
- •Exclusion of other causes of esophageal eosinophilia.
排除标准
- •Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
- •Participants with a stricture on endoscopy that prevents passage of the endoscope;
- •History of alcohol abuse or drug use;
- •Use of concomitant therapies for any reason that may affect the assessment;
- •History of gastroesophageal surgery;
- •History of the abnormal gastrointestinal disorder;
- •Another disorder that causes esophageal eosinophilia;
- •Pregnancy or risk of pregnancy and lactating patients;
- •Participants with known allergy, contraindication or hypersensitivity to the components of the medicine used in the clinical trial;
- •Participation in clinical trial in the year prior to this study.
研究组 & 干预措施
Florence 30
Experimental
干预措施: Florence 30 μg/mL (Drug)
Florence 60
Experimental
干预措施: Florence 60 μg/mL (Drug)
Florence 90
Experimental
干预措施: Florence 90 μg/mL (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Proportion of participants presenting a histological response, defined as the presence of ≤ 6 eosinophils/high-power field, at the end of treatment.
时间窗: 100 days
次要结局
- Incidence and severity of adverse events recorded during the study.(170 days)
研究者
研究点 (1)
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