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Clinical efficacy and safety of Metamizole 2 g i.v. versus placebo, as antithermic therapy in the acute phase of ischemic stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metamizole | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metamizole | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the functional outcome according to the Scandinavian Stroke Scale (SSS) | after 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of functional outcome according to SSS | Baseline, after 3 and 7 days | |
| Number of patients with score of SSS < 30 points | after 30 days | |
| Clinical impression assessed on the Modified Rankin Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004177 | Dipyrone |
| ID | Term |
|---|---|
| D000632 | Aminopyrine |
| D047069 | Pyrazolones |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D006573 |
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|
| after 30 days |
| Effect on the activities of daily living assessed on Barthel Index | after 30 days |
| Number of patients requiring rescue therapy | up to 30 days |
| Duration of hospital stay | up to 30 days |
| Assessment of tympanic temperature | up to 3 days after start of treatment |
| Percentage of mortality | after 30 days |
| Number of patients with adverse events | up to 30 days |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |