NCT00649415已完成4 期
A Double Blind, Double Dummy, Randomized, Comparative Study Of The Efficacy And Safety Of Valdecoxib 40 Mg BID, PRN In The First Menstrual Cycle Day And Then Once A Day, And Piroxicam 40 Mg Once A Day In The Treatment Of Patients With Primary Dysmenorrhea
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Total pain relief were calculated as the summed weighted pain releif scores
研究概览
简要总结
To compare the analgesic efficacy, safety, and tolerability of valdecoxib versus piroxicam in subjects with moderate to severe menstrual cramping pain associated 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)
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •History of primary dysmenorrhea with moderate to severe menstrual cramping pain for which the patient took analgesic medication for at least three of six previous menstrual cycles before enrollment
- •Subjects were to have been in good health and were to have had a complete physical exam (including a pap smear and an endovaginal or pelvic ultrasound, unless the subject had had these examinations performed within 6 months prior to the Screening Visit and the results were normal) prior to inclusion
排除标准
- •Subjects who were pregnant, lactating, breastfeeding or not using adequate methods of birth control
研究组 & 干预措施
Arm 1
Active Comparator
干预措施: piroxicam (Drug)
Arm 2
Active Comparator
干预措施: valdecoxib (Drug)
结局指标
主要结局
Total pain relief were calculated as the summed weighted pain releif scores
时间窗: 8 hours
次要结局
- adverse events(approximately 5 days after treated cycle)
- Subjects' global evaluation of the study drug(8 hours and 72 hours)
- Summed pain intensity difference(8 hours)
- laboratory analyses(screening)
- Percent of subjects who took rescue medication(72 hours)
- Percent of subjects who took the second dose of study medication(72 hours)
研究者
研究点 (1)
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