Clinical trial NCT00449787: Comparing Naproxen to Sumatriptan for Emergency Headache Patients
Official title: A Randomized Clinical Trial to Compare Naproxen and Sumatriptan for Headache Patients Discharged From the Emergency Department (ED)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine
Tension-type Headache
Primary Headache Disorder
Keywords: Emergency department
headache
migraine
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2007-03-21
Enrollment: 401
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Numerical Rating Scale
timeFrame: Baseline, two hours
Secondary outcomes:
measure: Headache-related Functional Disability
timeFrame: Baseline, two hours
measure: Patient Satisfaction
timeFrame: 48 hours after ER discharge
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Benjamin W. Friedman, MD,MS
role: PRINCIPAL_INVESTIGATOR
References: