Comparing Naproxen to Sumatriptan for Emergency Headache Patients
HEDNet2
A Randomized Clinical Trial to Compare Naproxen and Sumatriptan for Headache Patients Discharged From the Emergency Department (ED)
1 other identifier
interventional
401
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2007
Typical duration for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 19, 2007
CompletedFirst Posted
Study publicly available on registry
March 21, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedResults Posted
Study results publicly available
November 29, 2012
CompletedMay 31, 2018
May 1, 2018
2.3 years
March 19, 2007
July 13, 2011
May 1, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Numerical Rating Scale
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
Baseline, two hours
Secondary Outcomes (2)
Headache-related Functional Disability
Baseline, two hours
Patient Satisfaction
48 hours after ER discharge
Study Arms (2)
Sumatriptan
ACTIVE COMPARATORSumatriptan 100 mg tablet
Naproxen
ACTIVE COMPARATORNaproxen 500 mg tablet
Interventions
Eligibility Criteria
You may qualify if:
- Treated in the emergency department for acute primary headache
You may not qualify if:
- Allergy, intolerance, or contra-indication to one of the study medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Columbia University Medical Center
New York, New York, 10032, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Benjamin Friedman
- Organization
- Montefiore Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Benjamin W. Friedman, MD,MS
Albert Einstein College of Medicine
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
March 19, 2007
First Posted
March 21, 2007
Study Start
March 1, 2007
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
May 31, 2018
Results First Posted
November 29, 2012
Record last verified: 2018-05