A Randomized, Placebo-and Active-Comparator-Controlled Study of Etoricoxib 120 mg in the Treatment of Primary Dysmenorrhea
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 129
- 主要终点
- Overall analgesic effect as measured by the total pain relief score over 8 hours post dose (TOPAR8), sum of pain intensity difference over 8 hours post dose (SPID8), and patient's global evaluation at 8 and 24 hours post dose compared with placebo
研究概览
简要总结
The purpose of this study is to evaluate the pain relieving effect and safety of an investigational drug in women with moderate to severe primary dysmenorrhea (painful menstruation).
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women 18 years of age or older suffering from painful menstruation
排除标准
- •Women taking medications that are not allowed in the study (such as pain medications, antidepressants, tranquilizers, hypnotics, sedatives, or oral contraceptives).
- •Women who are pregnant, breast-feeding or within 6 weeks of giving birth
研究组 & 干预措施
1
etoricoxib
干预措施: etoricoxib (MK0663) (Drug)
结局指标
主要结局
Overall analgesic effect as measured by the total pain relief score over 8 hours post dose (TOPAR8), sum of pain intensity difference over 8 hours post dose (SPID8), and patient's global evaluation at 8 and 24 hours post dose compared with placebo
时间窗: Up to 8 hours postdose and at 8 and 24 hours postdose, following onset of moderate-to-severe pain due to primary dysmenorrhea for each of three consecutive menstrual cycles
Time to onset, peak, and duration of the analgesic effect compared with placebo
时间窗: to 24 hours following onset of moderate-to-severe pain due to primary dysmenorrhea for each of three consecutive menstrual cycles
次要结局
- Overall analgesic effect, time to onset, peak, and duration of analgesic effect compared with naproxen sodium(Up to 24 hours following onset of moderate-to-severe pain due to primary dysmenorrhea for each of three consecutive menstrual cycles)
- Overall analgesic effect, time to onset, peak, and duration of analgesic effect of naproxen sodium compared with placebo(Up to 24 hours following onset of moderate-to-severe pain due to primary dysmenorrhea for each of three consecutive menstrual cycles)
- Safety and tolerability of etoricoxib as assessed by the number of patients with clinical or laboratory adverse experiences(From randomization through 14 days following the last dose of study medication)