Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00449787
Status:
COMPLETED
Last Update Posted:
2018-05-31
First Post:
2007-03-19
Brief Title:
Comparing Naproxen to Sumatriptan for Emergency Headache Patients
Sponsor:
Montefiore Medical Center
Organization:
Montefiore Medical Center
Study Overview
Official Title:
A Randomized Clinical Trial to Compare Naproxen and Sumatriptan for Headache Patients Discharged From the Emergency Department ED
Status:
COMPLETED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEDNet2
Brief Summary:
23 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 ΒΌ 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None