Comparing Naproxen to Sumatriptan for Emergency Headache Patients

NCT ID: NCT00449787

Last Updated: 2018-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 401 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2009-07-31

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.

Conditions

Migraine; Tension-type Headache; Primary Headache Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Sumatriptan

Sumatriptan 100 mg tablet

Group Type: ACTIVE_COMPARATOR

Sumatriptan 100 mg

Intervention Type: DRUG

Sumatriptan 100mg tablet

Naproxen

Naproxen 500 mg tablet

Group Type: ACTIVE_COMPARATOR

Naproxen

Intervention Type: DRUG

Naproxen 500mg tablet

Interventions

Sumatriptan 100 mg

Sumatriptan 100mg tablet

Intervention Type: DRUG

Naproxen

Naproxen 500mg tablet

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Montefiore Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Benjamin W. Friedman, MD

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benjamin W. Friedman, MD,MS

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Locations

Columbia University Medical Center

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Countries

United States

Related Links

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2902611/

Study manuscript posted on Pubmed Central

Other Identifiers

06-11-472

Identifier Type: -

Identifier Source: org_study_id