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. Identifier: NCT00449787
Recruitment Status : Completed
First Posted : March 21, 2007
Results First Posted : November 29, 2012
Last Update Posted : November 29, 2012
Information provided by (Responsible Party):
Benjamin Friedman, Montefiore Medical Center

March 19, 2007
March 21, 2007
July 13, 2011
November 29, 2012
November 29, 2012
March 2007
July 2009   (Final data collection date for primary outcome measure)
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

Pain intensity score
Complete list of historical versions of study NCT00449787 on Archive Site
  • 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.
  • Advere effects
  • Headache-related Functional Disability
  • Patient Satisfaction
Not Provided
Not Provided
Comparing Naproxen to Sumatriptan for Emergency Headache Patients
A Randomized Clinical Trial to Compare Naproxen and Sumatriptan for Headache Patients Discharged From the Emergency Department (ED)
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.

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.

Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Migraine
  • Tension-type Headache
  • Primary Headache Disorder
  • Drug: Sumatriptan 100 mg
    Sumatriptan 100mg tablet
  • Drug: Naproxen
    Naproxen 500mg tablet
  • Active Comparator: Sumatriptan
    Sumatriptan 100 mg tablet
    Intervention: Drug: Sumatriptan 100 mg
  • Active Comparator: Naproxen
    Naproxen 500 mg tablet
    Intervention: Drug: Naproxen
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2009
July 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Treated in the emergency department for acute primary headache

Exclusion Criteria:

  • Allergy, intolerance, or contra-indication to one of the study medications
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Benjamin Friedman, Montefiore Medical Center
Montefiore Medical Center
Not Provided
Principal Investigator: Benjamin W. Friedman, MD,MS Albert Einstein College of Medicine, Inc.
Montefiore Medical Center
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP