NCT02280616已完成2 期
Double-blind, Double-dummy, Randomized, Placebo-controlled, Phase IIa Study on the Efficacy and Tolerability of a 14-day Treatment With Budesonide Effervescent Tablets vs. Viscous Budesonide Suspension vs. Placebo in Patients With 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
- 76
- 试验地点
- 1
- 主要终点
- Rate of histological remission
研究概览
简要总结
The purpose of this study is to assess the efficacy of a low and high dose of a budesonide effervescent tablet and oral viscous budesonide suspension vs. placebo for the induction treatment of active 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 clinicopathological diagnosis of EoE according to established diagnostic criteria:
- •(A) Clinical symptoms of esophageal dysfunction (B) Peak eosinophils ≥ 15 in at least 1 high-power field (hpf)
- •Active symptomatic and histological EoE at baseline
排除标准
- •Clinically and endoscopically suspicion for gastroesophageal reflux disease, achalasia, or sklerodermia
- •Gastroesophageal reflux disease and PPI-responsive esophageal eosinophilia
- •Other clinical 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)
- •Any relevant systemic disease (e.g., AIDS, active tuberculosis)
- •Abnormal hepatic function at screening visit, liver cirrhosis, or portal hypertension
- •Abnormal renal function at screening
- •History of cancer in the last five years (except for non-metastatic cancers, e.g., basalioma)
- •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
- •Concomitant, or within the 4 weeks prior to screening visit, treatment with systemic therapies for any reason that may affect assessment of primary and secondary endpoints, i.e., systemic glucocorticoids, histamine antagonists, mast cell stabilizers, leukotriene receptor antagonists, biologics, or immunosuppressants
- •Concomitant, or within the 2 weeks prior to screening visit, treatment with topical therapies for any reason that may affect assessment of primary and secondary endpoints, i.e., topical glucocorticoids or inhaled sodium cromoglycate
- •Installation of dietary restrictions within 4 weeks prior to screening visit or during treatment
- •Intake of grapefruit containing food or beverages during the treatment with study medication
- •Known intolerance/hypersensitivity to study drug
- •Existing or intended pregnancy or breast-feeding
研究组 & 干预措施
Low dose budesonide tablet
Experimental
干预措施: low dose budesonide tablet (Drug)
High dose budesonide tablet
Experimental
干预措施: high dose budesonide tablet (Drug)
High dose budesonide suspension
Experimental
干预措施: high dose budesonide suspension (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Rate of histological remission
时间窗: 2 weeks (LOCF)
Change in the mean numbers of eos
时间窗: 2 weeks (LOCF)
次要结局
- Change in the mean numbers of eos(2 weeks (LOCF))
研究者
研究点 (1)
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