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An RCT to Compare Naproxen to Sumatriptan for Headache Patients Discharged (HEDNet2)
This study is ongoing, but not recruiting participants.
Study NCT00449787   Information provided by Montefiore Medical Center
First Received: March 19, 2007   Last Updated: October 27, 2009   History of Changes

March 19, 2007
October 27, 2009
March 2007
July 2009   (final data collection date for primary outcome measure)
Pain intensity score [ Time Frame: 48 hours after ED discharge ] [ Designated as safety issue: No ]
Pain intensity score
Complete list of historical versions of study NCT00449787 on ClinicalTrials.gov Archive Site
  • Adverse effects [ Time Frame: 48 hours after ED discharge ] [ Designated as safety issue: Yes ]
  • Headache-related functional disability [ Time Frame: 48 Hours after ED discharge ] [ Designated as safety issue: No ]
  • Patient satisfaction [ Time Frame: 48 hours after ED discharge ] [ Designated as safety issue: No ]
  • Advere effects
  • Headache-related functional disability
  • Patient satisfaction
 
An RCT to Compare Naproxen to Sumatriptan for Headache Patients Discharged
An RCT to Compare Naproxen and Sumatriptan for Headache Patients Discharged From the Emergency Department

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 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.

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 and which is more efficacious for the subset of headache patients with an acute migraine.
  2. To determine the feasibility of grouping all primary headache disorder patients into one category for analysis.

Primary hypotheses:

1A. In the 48 hour period following ED treatment for migraine, sumatriptan 100mg will relieve pain better than naproxen 500mg, as measured by an 11-point numerical rating scale for pain.

1B. 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.

2. Methodology hypothesis: When compared to those subjects with an acute migraine, "headache" patients who do not meet International Headache Society migraine criteria will demonstrate similar variability in response to treatment.

Phase IV
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
  • Migraine
  • Tension-Type Headache
  • Primary Headache Disorder
  • Drug: Sumatriptan 100mg
  • Drug: Naproxen
  • Active Comparator: Sumatriptan 100mg po
  • Active Comparator: Naproxen 500mg po
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
352
July 2009
July 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Treated in the emergency department for acute primary headache

Exclusion Criteria:

  • Allergy, intolerance, or contra-indication to one of the study medications
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00449787
Benjamin Friedman, Montefiore Medical Center
HEDNet2
Montefiore Medical Center
 
Principal Investigator: Benjamin W. Friedman, MD,MS Albert Einstein College of Medicine of Yeshiva University
Montefiore Medical Center
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP