Comparing Naproxen to Sumatriptan for Emergency Headache Patients (HEDNet2)
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|ClinicalTrials.gov Identifier: NCT00449787|
Recruitment Status : Completed
First Posted : March 21, 2007
Results First Posted : November 29, 2012
Last Update Posted : May 31, 2018
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|Condition or disease||Intervention/treatment||Phase|
|Migraine Tension-type Headache Primary Headache Disorder||Drug: Sumatriptan 100 mg Drug: Naproxen||Phase 4|
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.
1) To determine which of two oral medications is more efficacious for all acute primary headache patients who are discharged from an ED.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||401 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized Clinical Trial to Compare Naproxen and Sumatriptan for Headache Patients Discharged From the Emergency Department (ED)|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 2009|
Active Comparator: Sumatriptan
Sumatriptan 100 mg tablet
Drug: Sumatriptan 100 mg
Sumatriptan 100mg tablet
Active Comparator: Naproxen
Naproxen 500 mg tablet
Naproxen 500mg tablet
- Numerical Rating Scale [ Time Frame: 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
- Headache-related Functional Disability [ Time Frame: 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.
- Patient Satisfaction [ Time Frame: 48 hours after ER discharge ]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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|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Treated in the emergency department for acute primary headache
- Allergy, intolerance, or contra-indication to one of the study medications
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00449787
|United States, New York|
|Montefiore Medical Center|
|Bronx, New York, United States, 10467|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Benjamin W. Friedman, MD,MS||Albert Einstein College of Medicine|
|Responsible Party:||Benjamin W. Friedman, MD, Associate professor, Montefiore Medical Center|
|Other Study ID Numbers:||
|First Posted:||March 21, 2007 Key Record Dates|
|Results First Posted:||November 29, 2012|
|Last Update Posted:||May 31, 2018|
|Last Verified:||May 2018|
Headache Disorders, Primary
Central Nervous System Diseases
Nervous System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists