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临床试验/NCT00449787
NCT00449787已完成4 期

A Randomized Clinical Trial to Compare Naproxen and Sumatriptan for Headache Patients Discharged From the Emergency Department (ED)

Montefiore Medical Center2 个研究点 分布在 1 个国家目标入组 401 人开始时间: 2007年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
401
试验地点
2
主要终点
Numerical Rating Scale

研究概览

简要总结

2/3 of patients discharged from an emergency department after treatment for an acute headache will still be bothered by headache within 24 hours of emergency department (ED) treatment. The goal of this study is to compare two medications, naproxen and sumatriptan, to determine which is better for the treatment of recurrent headache within 24 hours of emergency department discharge.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

入选标准

  • Treated in the emergency department for acute primary headache

排除标准

  • Allergy, intolerance, or contra-indication to one of the study medications

研究组 & 干预措施

Sumatriptan

Active Comparator

Sumatriptan 100 mg tablet

干预措施: Sumatriptan 100 mg (Drug)

Naproxen

Active Comparator

Naproxen 500 mg tablet

干预措施: Naproxen (Drug)

结局指标

主要结局

Numerical Rating Scale

时间窗: Baseline, two hours

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

次要结局

  • Headache-related Functional Disability(Baseline, two hours)
  • Patient Satisfaction(48 hours after ER discharge)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Benjamin W. Friedman, MD

Associate professor

Montefiore Medical Center

研究点 (2)

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