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Study canceled by decision strategically.
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The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different associations of drugs in the treatment of patients diagnosed with tensional-type headache in accordance with International Headache Society guidelines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MIGRANE | Experimental | 1 to 2 tablets ergotamine 1mg + caffeine 100mg + acetylsalicylic 350 mg + homatropine 1,2 mg |
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| PARCEL | Active Comparator | 1 to 2 tablets(ergotamine 1mg + paracetamol 450 mg + caffeine 40 mg) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MIGRANE | Drug | 1 to 2 tablets(ergotamine 1mg + caffeine 100mg + acetylsalicylic 350 mg + homatropine 1,2 mg) |
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| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of treatment in relieve headache symptoms. | The evaluation of efficacy will be determined based on comparison of the intensity of headache before and after 30, 60 and 90 minutes of initiation of treatment. | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of study treatment | Tolerability will be assessed by the investigator through the number of adverse events definitely related to study medication. This relationship will be defined by applying the Naranjo algorithm. | 56 days |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D006261 | Headache |
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| PARCEL | Drug | 1 to 2 tablets(ergotamine 1mg + paracetamol 450 mg + caffeine 40 mg) |
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| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |