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The purpose of this study is to show the efficacy of promethazine in management of patients with moderate to severe migraine
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sumatriptan+promethazine (SPr) | Active Comparator | The SPr group denote patients receiving oral sumatriptan (50 mg) plus oral promethazine (50 mg). |
|
| Sumatriptan+placebo (SP) | Placebo Comparator | The SP group denote patients receiving oral sumatriptan (50 mg) plus tablet of placebo matched to promethazine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sumatriptan+Promethazine (SPr) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete headache relief | The primary endpoint variable was the proportions of patients reporting complete headache relief 2 hours after dosing. | At 2 hours after first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Complete headache relief | The secondary endpoint variable was the proportions of patients reporting complete headache relief 0.5 hour, 1 hour, and 4 hours after dosing. | At 0.5 hour, 1 hour, and 4 hours after first dose |
| Headache improvement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, Emam Hossein Hospital | Tehran | Tehran Province | 17666-33812 | Iran |
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| ID | Term |
|---|---|
| D020325 | Migraine with Aura |
| D020326 | Migraine without Aura |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
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The secondary endpoint variable was the proportion of patients experiencing headache improvement at 0.5 hour, 1 hour, 2 hours, 4 hours after dosing.
| At 0.5 hour, 1 hour, 2 hours, 4 hours after first dose. |
| Using the second dose of study medications. | The secondary endpoint variable was the use of second dose when the severity of headache was still moderate or severe after the first dose within 2-48 hours | At 2-48 hours after first dose. |
| Using rescue medication between 2 and 48 hours postdose | The secondary endpoint variable was the use of rescue medication (excluding triptans, and ergot-containing medication) within 4-48 hours after the second dose when headache severity was still at grade 2 ⁄ 3. | At 4-48 hours after second dose. |
| Rate of headache recurrence | The secondary endpoint variable was a return to moderate or severe pain within 48 hours of first dose subsequent to primary improvement to mild or no pain at 2 hours. | At 2-48 hours after first dose. |
| Occurrence of adverse events. | Presence or absence of adverse events occurred 4 hours after first dosing. | At 4 hours after first dose. |
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |