NCT04541134Unknown3 期
A Multi-center, Randomized, Placebo-controlled, Double-blind, Cross-over, Phase 3 Clinical Trial to Evaluate of the Efficacy and Safety of DW9801 in Patients With Primary Dysmenorrhea
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 120
- 主要终点
- TOTPAR-8
研究概览
简要总结
A Multi-center, Randomized, Placebo-controlled, Double-blind, Cross-over, Phase 3 Clinical Trial to Evaluate of the Efficacy and Safety of DW9801 in Patients with Primary Dysmenorrhea
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double-blind
入排标准
- 年龄范围
- 19 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients, age between 19 years to 44years
- •Patients with menstrual pain over 4 out of 6 menstrual cycles before screening
- •Patients with moderate or severe menstrual pain for recent 2 menstrual cycles
- •Patients with regular menstrual cycles(28±7 days) for a year
排除标准
- •Patients diagnosed or suspected of secondary dysmenorrhea
- •Previous adverse reaction or known allergy to NSAIDs
- •Breast feeding woman
- •Patients who are not willing to use proper contraception during clinical trial period
研究组 & 干预措施
Group 1
Other
干预措施: Pelubiprofen 45mg (Drug)
Group 1
Other
干预措施: Placebo (Drug)
Group 2
Other
干预措施: Pelubiprofen 45mg (Drug)
Group 2
Other
干预措施: Placebo (Drug)
结局指标
主要结局
TOTPAR-8
时间窗: Day 1
Time weighted sum of total pain relief
SPID-8
时间窗: Day 1
Sum of pain intensity difference
次要结局
未报告次要终点
研究者
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