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A randomized, double-blind, active-controlled, parallel, multicenter Phase 3 study of Tramadol hydrochloride/Acetaminophen SR Tab. & Tramadol hydrochloride/Acetaminophen Tab. in Acute Toothache Patients above Moderate Pain after Teeth Extraction Surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tramadol hydrochloride/Acetaminophen Tab. | Active Comparator | 1tab PO within 5hours from teeth extraction |
|
| Tramadol hydrochloride/Acetaminophen SR Tab. | Experimental | 1tab PO within 5hours from teeth extraction and then 1tab more after 6hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tramadol hydrochloride/Acetaminophen Tab. | Drug |
| ||
| Tramadol hydrochloride/Acetaminophen SR Tab. |
| Measure | Description | Time Frame |
|---|---|---|
| SPID ; Sum of the pain intensity differences | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Drug |
|
| ID | Term |
|---|---|
| D014147 | Tramadol |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
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