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This study will test the efficacy and safety of topical diclofenac sodium gel 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 |
|---|---|---|
| WOMAC pain score in target knee at Week 12 | ||
| WOMAC physical function score in target knee at Week 12 | ||
| Global rating of disease activity by patient at Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC pain and physical function scores in target knee and global rating of disease activity by patient at Weeks 1, 4 and 8 | ||
| WOMAC stiffness score, pain on movement and spontaneous pain in target knee, and global rating of benefit by patient, at Weeks 1, 4, 8 and 12 |
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Key Inclusion 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 |
|---|---|---|---|
| 21174485 | Derived | Baraf HS, Gloth FM, Barthel HR, Gold MS, Altman RD. Safety and efficacy of topical diclofenac sodium gel for knee osteoarthritis in elderly and younger patients: pooled data from three randomized, double-blind, parallel-group, placebo-controlled, multicentre trials. Drugs Aging. 2011 Jan 1;28(1):27-40. doi: 10.2165/11584880-000000000-00000. |
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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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| Pain on movement in target knee and use of rescue medication recorded in diary |
| Global evaluation of treatment at final visit |
| Treatment responder rate according to OARSI criteria |