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This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of hand osteoarthritis.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diclofenac sodium gel 1% | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| OA pain intensity in target hand at Week 4 and 6 | ||
| Total AUSCAN score in target hand at Week 4 and 6 | ||
| Global rating of disease activity by patient at Week 4 and 6 |
| Measure | Description | Time Frame |
|---|---|---|
| OA pain intensity and total AUSCAN score in target hand, and global rating of disease activity by patient at Weeks 1, 2 and 8 | ||
| AUSCAN pain, stiffness and physical function scores in target hand, and global rating of benefit by patient at Weeks 1, 2, 4, 6 and 8 |
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Key Inclusion criteria:
• Osteoarthritis of the hand
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cergy | 95000 | France | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20064249 | Derived | Barthel HR, Peniston JH, Clark MB, Gold MS, Altman RD. Correlation of pain relief with physical function in hand osteoarthritis: randomized controlled trial post hoc analysis. Arthritis Res Ther. 2010;12(1):R7. doi: 10.1186/ar2906. Epub 2010 Jan 11. |
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| OA pain intensity in target hand and use of rescue medication recorded in diary |
| Global evaluation of treatment at final visit |
| Treatment responder rate according to OARSI criteria |
| Clamart |
| 92140 |
| France |
| Cournonterral | 34660 | France |
| Fellering | 68470 | France |
| Goussonville | 78930 | France |
| Linas | 91310 | France |
| Longpont-sur-Orge | 91310 | France |
| Meaux | 77100 | France |
| Nantes | 44000 | France |
| Orly | 94310 | France |
| Paris | 75010 | France |
| Paris | 75011 | France |
| Paris | 75015 | France |
| Paris | 75020 | France |
| Savigny-sur-Orge | 91600 | France |
| Thouars | 79100 | France |
| Villeneuve-le-Roi | 94290 | France |
| Bad Hersfeld | 36251 | Germany |
| Bad Nauheim | 61231 | Germany |
| Berlin | 10589 | Germany |
| Berlin | 10711 | Germany |
| Berlin | 10961 | Germany |
| Berlin | 12247 | Germany |
| Berlin | 13125 | Germany |
| Berlin | 13581 | Germany |
| Berlin | 14163 | Germany |
| Bochum | 44789 | Germany |
| Dinslaken | 46535 | Germany |
| Dortmund | 44263 | Germany |
| Dreieich | 63303 | Germany |
| Dresden | 01129 | Germany |
| Frankfurt a/M | 60433 | Germany |
| Hagen | 58099 | Germany |
| Hamburg | 20249 | Germany |
| Hamburg | 20357 | Germany |
| Hamburg | 22143 | Germany |
| Hamburg | 22767 | Germany |
| Karlsruhe | 76133 | Germany |
| Kassel | 34123 | Germany |
| Leipzig | 04109 | Germany |
| Ludwigshafen | 67069 | Germany |
| München | 80333 | Germany |
| München | 80339 | Germany |
| München | 80538 | Germany |
| München | 80798 | Germany |
| Neustadt/Aisch | 91413 | Germany |
| Nuremberg | 90441 | Germany |
| Stuttgart | 70178 | Germany |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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