NCT02434029已完成3 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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Rate of clinico-pathological remission
研究概览
简要总结
The purpose of this study is to prove the superiority of a 6-weeks treatment with budesonide effervescent tablets versus placebo for the induction of clinico-pathological remission in patients with acute eosinophilic esophagitis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •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.
排除标准
- •Clinical and endoscopic signs 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.
研究组 & 干预措施
Budesonide
Experimental
Budesonide 1mg orodispersible tablet twice daily
干预措施: Budesonide 1mg orodispersible tablet twice daily (Drug)
Placebo
Placebo Comparator
Placebo orodispersible tablet twice daily
干预措施: Placebo orodispersible tablet twice daily (Drug)
结局指标
主要结局
Rate of clinico-pathological remission
时间窗: 6 weeks
次要结局
- Rate of patients with histological remission(6 weeks)
- Rate of patients with resolutions of symptoms measured by numerical rating score of symptoms(week 6)
研究者
研究点 (1)
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