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The purpose of this study is to evaluate the efficacy of S (+) - ibuprofen compared to an active treatment for pain control in individuals diagnosed with osteoarthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S (+) - Ibuprofen | Experimental | S (+) - Ibuprofen (1 coated tablet) + placebo of Ibuvix® - ibuprofen (1 coated tablet) Every 6 hours for 28 days. |
|
| Ibuvix® - ibuprofen | Active Comparator | Ibuvix® - ibuprofen (1 coated tablet) + placebo of S (+) - Ibuprofen (1 coated tablet) Every 6 hours for 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S (+) - Ibuprofen | Drug | S (+) - Ibuprofen + placebo of Ibuvix® |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean reduction of pain measured by the WOMAC Osteoarthritis Index (pain) | Baseline (day 0) and Week 4 (day 28) |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Impression of Improvement-I (PGI-I) | Week 4 (day 28) | |
| Proportion of participants among the groups to discontinue the trial due to treatment non-tolerability | From Baseline (day 0) to Week 4 (day 28) |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Apsen Farmacêutica S.A. | São Paulo | 04753-001 | Brazil |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D010146 | Pain |
| D007249 | Inflammation |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Ibuvix® - ibuprofen |
| Drug |
Ibuvix® + placebo of S(+) - Ibuprofen |
|
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |