Phase 4
N=401
Comparing Naproxen to Sumatriptan for Emergency Headache Patients
Migraine · Tension-type Headache · Primary Headache Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00449787 ↗Enrolled (actual)
401
Serious AEs
0.0%
Results posted
Nov 2012
Primary outcome: Primary: Numerical Rating Scale — 4.1; 4.3 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sumatriptan 100 mg (Drug); Naproxen (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Montefiore Medical Center
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Numerical Rating Scale |
4.1; 4.3 | — |
| SECONDARY Headache-related Functional Disability |
41; 36 | — |
| SECONDARY Patient Satisfaction |
69; 68 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00449787). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.