NCT00329355已完成3 期
A Randomized, Double-blind, Single Migraine Attack, Placebo-controlled, Parallel-group Multicenter Study to Evaluate the Efficacy and Tolerability of Trexima (Sumatriptan Succinate.Naproxen Sodium) Tablets vs Placebo When Administered During the Mild Pain Phase of Menstrual Migraine in Women With Dysmenorrhea
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 351
- 试验地点
- 36
- 主要终点
- Score on a 4-pt migraine pain scale for a single menstrual migraine attack
研究概览
简要总结
This study was designed to determine efficacy of TREXIMET (sumatriptan/naproxen sodium), formerly known as TREXIMA compared to placebo for the treatment of a menstrual migraine.
详细描述
A randomized, double-blind, single migraine attack, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and tolerability of TREXIMA* (sumatriptan succinate/naproxen sodium) tablets vs placebo when administered during the mild pain phase of menstrual migraine in women with dysmenorrhea (*TREXIMET)
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •At least a 6 month history of physician diagnosed migraine and typically experiences 2-6 migraine attacks per month
- •Typically experiences moderate to severe migraine pain preceded by a mild pain phase
- •Differentiate between mild migraine pain and other headache types
- •Women of childbearing potential must be on adequate contraception
排除标准
- •Pregnant and/or nursing mother
- •History of cardiovascular disease
- •Uncontrolled hypertension
- •Basilar or Hemiplegic migraine
- •History of stroke or transient ischemic attacks (TIA)
- •History of epilepsy or treated with anti-epileptics within past 5 years
- •Impaired hepatic or renal function
- •History of gastrointestinal bleeding or ulceration
- •Allergy or hypersensitivity to aspirin or any other NSAID
- •Allergy or hypersensitivity to triptans
- •Participated in an investigational drug trial in the previous 4 weeks
结局指标
主要结局
Score on a 4-pt migraine pain scale for a single menstrual migraine attack
时间窗: 2 to 48 hours
次要结局
- Freedom from all migraine pain and symptoms, satisfaction, presence or absence of neck pain/discomfort, sinus pain/pressure, menstrual symptoms, recurrence of head pain, safety and tolerability(2 to 48 hours)
研究者
研究点 (36)
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