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To assess the safety and efficacy of eletriptan for the treatment of migraine in subjects who had not been adequately treated with non-steroidal antiinflammatory drugs (NSAIDs)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eletriptan | Drug | 40 mg oral tablet for migraine attack; additional 40 mg oral tablet >2 hours from first dose if migraine reoccurred within 24 hours of achieving response |
|
| Measure | Description | Time Frame |
|---|---|---|
| Headache severity and response post-treatment | 2 hours | |
| Functional response post-treatment | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of associated symptoms including, nausea, vomiting, phonophobia, and photophobia at baseline and post-treatment | 1, 2, 4, and 24 hours | |
| Migraine recurrence post-treatment | 1, 2, 4, and 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Çapa | Istanbul | Turkey (Türkiye) | |||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Time loss (from normal activities and from work) post-treatment | 24 hours |
| Subject preference and acceptability post-treatment | 24 hours and 12 weeks |
| Subject satisfaction post-treatment | 2 and 24 hours |
| Adverse events | Week 12 |
| Physical examination | Week 12 |
| Vital signs | Week 12 |
| Electrocardiogram | Week 12 |
| Headache severity and response at baseline and post-treatment | 1, 4 and 24 hours |
| Functional impairment severity and response at baseline and post-treatment | 1, 4 and 24 hours |
| Gaziantep |
| Turkey (Türkiye) |
| Pfizer Investigational Site | Istanbul | Turkey (Türkiye) |
| Pfizer Investigational Site | Izmir | Turkey (Türkiye) |
| Pfizer Investigational Site | Samsun | Turkey (Türkiye) |
| Pfizer Investigational Site |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C115647 | eletriptan |
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