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临床试验/NCT00111709
NCT00111709已完成3 期

A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo Controlled Study to Evaluate the Efficacy and Tolerability of Rizatriptan 10 mg Tablets for the Treatment of Menstrual Migraine

Organon and Co0 个研究点目标入组 393 人开始时间: 2005年5月27日最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
393
主要终点
Percentage of patients with 2 hour pain relief: 4-point headache severity scale as recorded in patient diary

研究概览

简要总结

The purpose of this study is to test the effectiveness of a marketed drug in the treatment of a menstrual migraine attack.

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patient at least 18 years old
  • Patient has menses approximately monthly
  • Patient has at least a 5 month history of migraine and at least a 6 month history of menstrual migraine

排除标准

  • Pregnant and/or nursing
  • Cardiovascular disease
  • Uncontrolled hypertension

结局指标

主要结局

Percentage of patients with 2 hour pain relief: 4-point headache severity scale as recorded in patient diary

次要结局

  • Percentage of patients with 24-hr sustained pain relief: headache severity between 2 and 24 hrs post dose as recorded in patient diary

研究者

申办方类型
Industry
责任方
Sponsor

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