NCT00240617已完成3 期
A Randomized, Double-blind, Multi-center, Placebo-controlled, Cross-over Study to Determine the Consistency of Response for Trexima* (Sumatriptan 85mg/Naproxen Sodium 500mg) Administered During the Mild Pain Phase for the Acute Treatment of Multiple Migraine Attacks (*Treximet)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 623
- 试验地点
- 1
- 主要终点
- Score on a 4 pt migraine pain scale for multiple migraine attacks
研究概览
简要总结
The purpose of this study is to determine the consistency of response for Treximet (formerly known as Trexima) when treating four acute migraine attacks at the mild pain phase and within 1 hour of onset of head pain.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 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.
研究组 & 干预措施
arm 1
Active Comparator
Treximet (sumatriptan/naproxen sodium) formerly known as TREXIMA
干预措施: sumatriptan succinate/naproxen sodium (Drug)
arm 2
Placebo Comparator
placebo to match
干预措施: placebo (Drug)
结局指标
主要结局
Score on a 4 pt migraine pain scale for multiple migraine attacks
时间窗: 2 to 24 hours
次要结局
- Within patient consistency of response, freedom from all migraine pain and symptoms, satisfaction, presence or absence of neck pain/discomfort, sinus pain/pressure, recurrence of head pain, safety and tolerability(2 to 24 hours)
研究者
研究点 (1)
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