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| Sponsor: | Montefiore Medical Center |
|---|---|
| Information provided by: | Montefiore Medical Center |
| ClinicalTrials.gov Identifier: | NCT00449787 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Migraine Tension-Type Headache Primary Headache Disorder |
Drug: Sumatriptan 100mg Drug: Naproxen |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | An RCT to Compare Naproxen and Sumatriptan for Headache Patients Discharged From the Emergency Department |
| Estimated Enrollment: | 352 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | July 2009 |
| Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Sumatriptan
Sumatriptan 100mg po
|
Drug: Sumatriptan 100mg
Sumatriptan 100mg po
|
|
Active Comparator: Naproxen
Naproxen 500mg po
|
Drug: Naproxen
Naproxen 500mg po
|
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:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New York | |
| Montefiore Medical Center | |
| Bronx, New York, United States, 10467 | |
| Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| Principal Investigator: | Benjamin W. Friedman, MD,MS | Albert Einstein College of Medicine of Yeshiva University |
More Information
| Responsible Party: | Benjamin Friedman, Montefiore Medical Center |
| ClinicalTrials.gov Identifier: | NCT00449787 History of Changes |
| Other Study ID Numbers: | HEDNet2 |
| Study First Received: | March 19, 2007 |
| Last Updated: | October 27, 2009 |
| Health Authority: | United States: Institutional Review Board |
|
Emergency department headache migraine |
|
Headache Tension-Type Headache Migraine Disorders Headache Disorders Headache Disorders, Primary Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Brain Diseases Central Nervous System Diseases Naproxen Sumatriptan Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Gout Suppressants Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents Vasoconstrictor Agents Cardiovascular Agents |