Comparing Naproxen to Sumatriptan for Emergency Headache Patients (HEDNet2)

• ClinicalTrials.gov Identifier: NCT00449787
• Recruitment Status: Completed
• First Posted: March 21, 2007
• Results First Posted: November 29, 2012
• Last Update Posted: May 31, 2018
• Sponsor: Montefiore Medical Center
• Information provided by (Responsible Party): Benjamin W. Friedman, MD, Montefiore Medical Center

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

More Information

Additional Information:

Study manuscript posted on Pubmed Central 

• 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
• 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; headache; migraine

Additional relevant MeSH terms:

Tension-Type Headache; Headache Disorders; Headache Disorders, Primary; Emergencies; Headache; Disease Attributes; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Naproxen; Sumatriptan; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; 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