NCT00719511已完成2 期
Single Center Phase I/IIa, Placebo Controlled, Randomized, Double-blind, Dose-response Study to Assess the Optimal Dose as Well as Clinical Efficacy and Safety of a Novel Method of Specific Allergen Immunotherapy in Grass Pollen Allergic Subjects by Epicutaneous Allergen Administration
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
- 132
- 主要终点
- Comparison of the efficacy of the placebo with that of three different test doses of the epicutaneous pollen allergen administration evaluated by visual analog scales after the treatment
研究概览
简要总结
Evaluation of patch as specific immunotherapy in allergic patients
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
3
Experimental
Patch allergen dose 3
干预措施: Purified allergen dose 3 integrated in a Patch system (Drug)
4
Experimental
Placebo
干预措施: Purified allergen integrated in a Patch system (Drug)
2
Experimental
Patch allergen dose 2
干预措施: Purified allergen dose 2 integrated in a Patch system (Drug)
1
Experimental
Patch allergen dose 1
干预措施: Purified allergen dose 1 integrated in a Patch system (Drug)
结局指标
主要结局
Comparison of the efficacy of the placebo with that of three different test doses of the epicutaneous pollen allergen administration evaluated by visual analog scales after the treatment
时间窗: 2010
次要结局
未报告次要终点
研究者
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