EUCTR2006-004820-35-IT进行中（未招募）不适用
Multicenter, randomized, parallel groups, semi-cross over, open Phase IIIB trial to evaluate treatment compliance for subglossal specific Immunotherapy oral lyophilisate tablets GrazaxR in patients suffering from allergic rhinoconjunctivitis caused by grass pollen - ND
ALK-ABELLO0 个研究点开始时间: 2007年3月9日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male and Female, aged between 18 and 65 years Moderate/severe intermittent rhinoconjunctivitis or mild-moderate persistent rhinoconjunctivitis according to ARIA diagnostic criteria Positive Skin Prick Test wheal diameter larger than 3mm to grass pollen allergen Phleum pratense No clinically relevant pathologies In case of child bearing potential women, a negative pregnancy Test is required at enrollment and tha subject must use an appropriate contraceptive methods for the whole duration of the trial Written Informed Consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Signs and Symptoms of acute infection to upper respiratory tract and /or acute otitis, and/or acute sinusitis at enrollment Admission in Emergency ward for ashtma attack during 12 months defore Visit 1 Past specific immunotherapy for allergens other than grass pollen during the past 2 years Past anaphylactic reactions food allergy, insect bites, drug allergy, anaphylaxis induced by exertion and/or angioedema Subject treated with immunosuppressive drugs Hypersensibility to tablets excipients
研究者
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