We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Comparing Naproxen to Sumatriptan for Emergency Headache Patients (HEDNet2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00449787
Recruitment Status : Completed
First Posted : March 21, 2007
Results First Posted : November 29, 2012
Last Update Posted : May 31, 2018
Information provided by (Responsible Party):
Benjamin W. Friedman, MD, Montefiore Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Migraine Tension-type Headache Primary Headache Disorder Drug: Sumatriptan 100 mg Drug: Naproxen Phase 4

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 401 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache

Arm Intervention/treatment
Active Comparator: Sumatriptan
Sumatriptan 100 mg tablet
Drug: Sumatriptan 100 mg
Sumatriptan 100mg tablet

Active Comparator: Naproxen
Naproxen 500 mg tablet
Drug: Naproxen
Naproxen 500mg tablet

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Treated in the emergency department for acute primary headache

Exclusion Criteria:

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

Information from the National Library of Medicine

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

Layout table for location information
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Montefiore Medical Center
Layout table for investigator information
Principal Investigator: Benjamin W. Friedman, MD,MS Albert Einstein College of Medicine
Additional Information:
Layout table for additonal information
Responsible Party: Benjamin W. Friedman, MD, Associate professor, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00449787    
Other Study ID Numbers: 06-11-472
First Posted: March 21, 2007    Key Record Dates
Results First Posted: November 29, 2012
Last Update Posted: May 31, 2018
Last Verified: May 2018
Keywords provided by Benjamin W. Friedman, MD, Montefiore Medical Center:
Emergency department
Additional relevant MeSH terms:
Layout table for MeSH terms
Tension-Type Headache
Headache Disorders
Headache Disorders, Primary
Disease Attributes
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents