NCT00240630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
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
- 646
- 试验地点
- 1
- 主要终点
- Score on a 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 (sumatriptan/naproxen sodium), 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
Placebo Comparator
placebo to match
干预措施: sumatriptan succinate/naproxen sodium (Drug)
Arm 2
Experimental
Treximet (sumatriptan/naproxen sodium)
干预措施: placebo (Drug)
结局指标
主要结局
Score on a 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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