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This study will test the efficacy and safety of topical Voltaren in the treatment of knee osteoarthritis.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diclofenac Topical Sodium Gel 1% | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events | ||
| Number of laboratory values outside pre-determined ranges at Months 1, 3, 6, 9 and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of serious treatment-emergent adverse events | ||
| Number of patients who discontinued study medication due to a treatment-emergent adverse event | ||
| WOMAC pain, physical function and stiffness scores at Months 3, 6, 9 and 12 |
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Key Inclusion criteria
• Osteoarthritis of the knee
Key Exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Consumer Health Inc. | Parsippany | New Jersey | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22030938 | Derived | Peniston JH, Gold MS, Alwine LK. An open-label, long-term safety and tolerability trial of diclofenac sodium 1% gel in patients with knee osteoarthritis. Phys Sportsmed. 2011 Sep;39(3):31-8. doi: 10.3810/psm.2011.09.1918. |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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