Comparing Naproxen to Sumatriptan for Emergency Headache Patients (HEDNet2)
A Randomized Clinical Trial to Compare Naproxen and Sumatriptan for Headache Patients Discharged From the Emergency Department (ED)
研究概览
详细说明
Two-thirds of the five million headache patients who present to US emergency departments (ED) annually are suffering an acute exacerbation of a primary headache disorder. Of these acute primary headaches, migraine is the most frequently encountered disease entity in the ED, accounting for 60% of primary headaches, followed by tension-type headaches, which represent 10% of all primary headaches seen in the ED. About ¼ of all acute primary headaches seen in the ED cannot readily be given a specific diagnosis3. Multiple parenteral treatments are used to treat acute primary headaches1, but to date, regardless of specific headache diagnosis, no medication eliminates the frequent recurrence of headache after ED discharge. To date, it is unknown which medication patients should be given when discharged from an ED after treatment for a primary headache. This study will compare two oral headache treatments to determine which one relives pain more effectively.
Specific aims:
1) To determine which of two oral medications is more efficacious for all acute primary headache patients who are discharged from an ED.
Primary hypotheses:
In the 48 hour period following ED treatment for a primary headache, sumatriptan 100mg will relieve pain better than naproxen 500mg, as measured by an 11-point numerical rating scale for pain.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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New York
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Bronx、New York、美国、10467
- Montefiore Medical Center
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New York、New York、美国、10032
- Columbia University Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Treated in the emergency department for acute primary headache
Exclusion Criteria:
- Allergy, intolerance, or contra-indication to one of the study medications
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:Sumatriptan
Sumatriptan 100 mg tablet
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Sumatriptan 100mg tablet
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有源比较器:Naproxen
Naproxen 500 mg tablet
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Naproxen 500mg tablet
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Numerical Rating Scale
大体时间:Baseline, two hours
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Within 48 hours of ED discharge, participants were allowed to take the investigational medication. At the moment they took the investigational medication, they were asked to record a number from 0 to 10, which represented their headache. 0 signified no pain and 10 signified the worse pain imaginable. Two hours later, participants were asked again to record their pain on a scale from 0 to 10. The outcome is the change in pain between baseline and two hours and will be a number between 0 and 10. Greater numbes signify greater relief |
Baseline, two hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Headache-related Functional Disability
大体时间:Baseline, two hours
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This is a recommend outcome in headache research.
At the time of the assessment (48 hours after ER discharge), patients are asked to report their current level of functional impairment: severe (unable to do any activities); moderate (able to do a few activities); mild (able to do many but not all activities) or none (able to do all activities).
For this analysis, patient's answers were dichotomized into some impairment or no impairment.
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Baseline, two hours
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Patient Satisfaction
大体时间:48 hours after ER discharge
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At the 48 hour assessment, patients were asked, "The next time you go to an emergency room with a headache, do you want to receive the same medication".
This outcome tabulates the number of affirmative responses.
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48 hours after ER discharge
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合作者和调查者
调查人员
- 首席研究员:Benjamin W. Friedman, MD,MS、Albert Einstein College Of Medicine
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Sumatriptan 100 mg的临床试验
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