- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00449787
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)
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
-
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New York
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Bronx, New York, 미국, 10467
- Montefiore Medical Center
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New York, New York, 미국, 10032
- Columbia University Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Treated in the emergency department for acute primary headache
Exclusion Criteria:
- Allergy, intolerance, or contra-indication to one of the study medications
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: Sumatriptan
Sumatriptan 100 mg tablet
|
Sumatriptan 100mg tablet
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활성 비교기: Naproxen
Naproxen 500 mg tablet
|
Naproxen 500mg tablet
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Numerical Rating Scale
기간: 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 |
Baseline, two hours
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Headache-related Functional Disability
기간: Baseline, two hours
|
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.
|
Baseline, two hours
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Patient Satisfaction
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Benjamin W. Friedman, MD,MS, Albert Einstein College of Medicine
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 06-11-472
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Sumatriptan 100 mg에 대한 임상 시험
-
Avanir Pharmaceuticals완전한
-
Kirby Institute모병
-
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-
OrthoTrophix, Inc완전한
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Madrigal Pharmaceuticals, Inc.초대로 등록