JPRN-jRCT2031230143进行中（未招募）3 期
A Phase III Study Evaluating Efficacy and Safety of Adrenaline of ARS-1 in Patients with Food Allergies
Kenya Morita0 个研究点目标入组 15 人开始时间: 2023年6月16日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 4age old 至 <= 55age old（—）
- 性别
- All
入选标准
- •1. Between the ages of 4 and 55 years at IC
- •2. Has body weight 15 kg or higher before OFC test at Day1
- •3. Is scheduled for an inpatient oral food challenge test.
- •4. Must have an oral food allergy that elicited symptoms of grade 2 or higher gastrointestinal, respiratory, or circulatory symptoms according to the Severity Classification of Organ Symptoms Induced by Anaphylaxis in the Anaphylaxis Guidelines of the Japanese Society of Allergology.
排除标准
- •1. Has prior nasal fractures, severe nasal injuries, history of nasal disorders, any nasal conditions that could interfere with nasal spray administration, abuse of nasal decongestants, or sleep apnea.
- •2. Has used nasal drugs within 14 days from Day1.
- •3. Has mucosal inflammatory disorders (e.g., pemphigus or Sjogren's syndrome or fungal sinusitis).
- •4. Known hypersensitivity to any compound in sympathomimetics or any compounds contained in investigational drugs (adrenaline, n-dodecyl-beta-D-maltoside, sodium edetate hydrate, benzalkonium chloride, sodium pyrosulfite) or other closely related compound.
研究者
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