NCT02552667已完成3 期
Efficacy and Safety of HCP1102 Capsule : A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Clinical Trial
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 228 人开始时间: 2014年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Change of Mean Daytime Nasal Symptom Score
研究概览
简要总结
Efficacy and safety of HCP1102 capsule : A randomized, double-blind, active-controlled, multicenter phase 3 clinical trial.
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
- 15 Years 至 —（Child, 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
HCP1102+HGP0711Placebo
Experimental
HCP1102Placebo+HGP0711Placebo(1week) -> HCP1102+HGP0711Placebo(4weeks) Each 1 capsule, once daily
干预措施: HCP1102+HGP0711Placebo (Drug)
HCP1102Placebo+HGP0711
Active Comparator
HCP1102Placebo+HGP0711Placebo(1week) -> HCP1102Placebo+HGP0711(4weeks) Each 1 capsule, once daily
干预措施: HCP1102Placebo+HGP0711 (Drug)
结局指标
主要结局
Change of Mean Daytime Nasal Symptom Score
时间窗: base line, 3-4week(2weeks)
次要结局
- Change of Runny nose (Mean Daytime Nasal Symptom Score)(base line, 1-2week(2weeks), 3-4week(2weeks))
- Change of pruritus (Mean Daytime Nasal Symptom Score)(base line, 1-2week(2weeks), 3-4week(2weeks))
- Change of Mean Nighttime Nasal Symptom Score(base line, 1-2week(2weeks), 3-4week(2weeks))
- Change of Mean Daytime Nasal Symptom Score(base line, 1-2week(2weeks), 3-4week(2weeks))
- Change of Mean Composite Symptom Score(base line, 1-2week(2weeks), 3-4week(2weeks))
- Change of sneezing (Mean Daytime Nasal Symptom Score)(base line, 1-2week(2weeks), 3-4week(2weeks))
研究者
研究点 (1)
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