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Comparing Naproxen to Sumatriptan for Emergency Headache Patients (HEDNet2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Benjamin Friedman, Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT00449787
First received: March 19, 2007
Last updated: October 29, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Migraine
Tension-type Headache
Primary Headache Disorder
Drug: Sumatriptan 100 mg
Drug: Naproxen
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • Numerical Rating Scale [ Time Frame: Baseline, two hours ] [ Designated as safety issue: No ]

    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:
  • Headache-related Functional Disability [ Time Frame: Baseline, two hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 401
Study Start Date: March 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Treated in the emergency department for acute primary headache

Exclusion Criteria:

  • Allergy, intolerance, or contra-indication to one of the study medications
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00449787

Locations
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
Investigators
Principal Investigator: Benjamin W. Friedman, MD,MS Albert Einstein College of Medicine of Yeshiva University
  More Information

Additional Information:
No publications provided

Responsible Party: Benjamin Friedman, Associate professor, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00449787     History of Changes
Other Study ID Numbers: HEDNet2
Study First Received: March 19, 2007
Results First Received: July 13, 2011
Last Updated: October 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Montefiore Medical Center:
Emergency department
headache
migraine

Additional relevant MeSH terms:
Headache Disorders
Headache Disorders, Primary
Emergencies
Headache
Tension-Type Headache
Brain Diseases
Central Nervous System Diseases
Disease Attributes
Nervous System Diseases
Neurologic Manifestations
Pain
Pathologic Processes
Signs and Symptoms
Naproxen
Sumatriptan
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Gout Suppressants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014