NCT00330850已完成3 期
An Efficacy Study of a Single Dose Treatment of PRO-513 for Subjects Suffering a Migraine Attack
ProEthic Pharmaceuticals32 个研究点 分布在 1 个国家目标入组 650 人开始时间: 2006年5月1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
- 发起方
- 入组人数
- 650
- 试验地点
- 32
研究概览
简要总结
The purpose of the study is to show the efficacy of a single dose of PRO-513 for treating subjects suffering moderate pain form a migraine attack, with or without aura. The study is also intended to show the effectiveness of PRO-513 for associated symptoms of nausea, photophobia, and phonophobia due to a migraine attack.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and Female subjects
- •18-65 years of age
- •Primary diagnosis of migraine attack with aura or migraine attack without aura
- •Migraine history of averaging at least 1 migraine attack per month but averaging not more than 6 migraine attacks per month over the prior year
- •Female subjects must use an effective form of birth control
- •Listing of additional inclusion criteria are available through the Sponsor
排除标准
- •Excluding subjects with a history of other serious events causing secondary headaches
- •Excluding subjects with a current medical condition that could interfere with the overall study intent or affect the absorption, distribution, metabolism, or excretion of the study medication
- •Excluding subjects with a history or current medical condition that could confound the study results or use of a concomitant medication that could interfere with the study drug
- •Listing of additional exclusion criteria are available through the Sponsor
研究者
研究点 (32)
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