NCT01940146已完成2 期
Efficacy and Safety of SPARC1310 in Seasonal Allergic Rhinitis
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
- 222
- 试验地点
- 1
- 主要终点
- Change in Total Nasal Symptom Score From Baseline to Day 14.
研究概览
简要总结
The study will assess the efficacy and safety of SPARC1310 when compared to placebo and active control
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
- Double (Participant, Investigator)
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
- •Male or female participants aged 18 to 65 years with history of seasonal allergic rhinitis
- •Participants able to understand and willing to sign the informed consent form
排除标准
- •Anotomical deviations of the nasal septum that significantly impair ventilation or airflow
- •Pregnant or nursing women
- •Positive serology for infectious disease (Hepatitis B or C, HIV) at screening
- •Parallel participation in another current investigational study, participation in a study within less than 30 days prior to study entry, or previous participation in this same study.
研究组 & 干预措施
SPARC1310 II
Experimental
干预措施: SPARC1310 II (Drug)
SPARC1310 III
Experimental
干预措施: SPARC1310 III (Drug)
SPARC Placebo
Placebo Comparator
干预措施: SPARC Placebo (Drug)
SPARC1310 I
Experimental
干预措施: SPARC1310 I (Drug)
结局指标
主要结局
Change in Total Nasal Symptom Score From Baseline to Day 14.
时间窗: Baseline to Day 14
The 4-point (0=None, 1=Mild, 2=Moderate, and 3=Severe) intensity scale was summed across multiple symptoms (nasal congestion, rhinorrhea, nasal itching, and sneezing). Thus, the TNSS scores could range from 0 to 12, with higher scores indicative of greater severity.
次要结局
未报告次要终点
研究者
研究点 (1)
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