Migraine Clinical Trial
— HEDNet2Official title:
A Randomized Clinical Trial to Compare Naproxen and Sumatriptan for Headache Patients Discharged From the Emergency Department (ED)
NCT number | NCT00449787 |
Other study ID # | 06-11-472 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | March 2007 |
Est. completion date | July 2009 |
Verified date | May 2018 |
Source | Montefiore Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 401 |
Est. completion date | July 2009 |
Est. primary completion date | July 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Treated in the emergency department for acute primary headache Exclusion Criteria: - Allergy, intolerance, or contra-indication to one of the study medications |
Country | Name | City | State |
---|---|---|---|
United States | Montefiore Medical Center | Bronx | New York |
United States | Columbia University Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Montefiore Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Headache-related Functional Disability | This is a recommend outcome in headache research. At the time of the assessment (48 hours after ER discharge), patients are asked to report their current level of functional impairment: severe (unable to do any activities); moderate (able to do a few activities); mild (able to do many but not all activities) or none (able to do all activities). For this analysis, patient's answers were dichotomized into some impairment or no impairment. | Baseline, two hours | |
Secondary | Patient Satisfaction | At the 48 hour assessment, patients were asked, "The next time you go to an emergency room with a headache, do you want to receive the same medication". This outcome tabulates the number of affirmative responses. | 48 hours after ER discharge |
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