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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sumatriptan | Active Comparator | Sumatriptan 100 mg tablet |
|
| Naproxen | Active Comparator | Naproxen 500 mg tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sumatriptan 100 mg | Drug | Sumatriptan 100mg tablet |
| |
| Naproxen |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin W. Friedman, MD,MS | Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States | ||
| Montefiore Medical Center |
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| Label | URL |
|---|---|
| Study manuscript posted on Pubmed Central | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sumatriptan | Sumatriptan 100 mg tablet |
| FG001 | Naproxen | Naproxen 500 mg tablet |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sumatriptan | Sumatriptan 100 mg tablet |
| BG001 | Naproxen | Naproxen 500 mg tablet |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | After discharge from the emergency room, some patients had headache requiring use of medication and some did not. Only those patients who took the investigational medication were included in the analysis | Posted | Mean | Standard Deviation | units on a scale | Baseline, two hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sumatriptan | Sumatriptan 100 mg tablet |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Various non-serious adverse events including myalgia, facial pains, and non-specific complaints |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Benjamin Friedman | Montefiore Medical Center | 718-920-6626 | bwfriedmanmd@gmail.com |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D018781 | Tension-Type Headache |
| D051270 | Headache Disorders, Primary |
| D004630 | Emergencies |
| D006261 | Headache |
| ID | Term |
|---|---|
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D018170 | Sumatriptan |
| D009288 | Naproxen |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| Drug |
Naproxen 500mg tablet |
|
| Baseline, two hours |
| 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 |
| The Bronx |
| New York |
| 10467 |
| United States |
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Naproxen | Naproxen 500mg tablet |
|
|
| 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. | Patients who reported any level of functional impairment (mild, moderate, or severe) are tabulated here. | Posted | Number | participants | 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. | Posted | Number | participants | 48 hours after ER discharge |
|
|
|
| 0 |
| 98 |
| 25 |
| 97 |
| EG001 | Naproxen | Naproxen 500 mg tablet | 0 | 98 | 18 | 97 |
|
| Gastrointestinal complaint | Gastrointestinal disorders | Non-systematic Assessment | nausea, vomiting, epigastric pain, or diarrhea |
|
| Neurological | Nervous system disorders | Non-systematic Assessment | Dizzy, lightheaded, non-specific weakness, drowsy, headache |
|
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| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Sulfur Compounds |
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |