Primary efficacy outcomes at Weeks 4, 6, and 8 (intent-to-treat population).
| Outcome Measure | Diclofenac Sodium Gel, n = 198 | Vehicle, n = 187 | p§ (change vs vehicle, % | ||
|---|---|---|---|---|---|
| Rating Mean ± SD % | Change From BL Mean ± SD | Rating Mean ± SD | Change From BL Mean ± SD | ||
| Week 4 | |||||
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| |||||
| OA pain intensity* | 42.6 ± 30.5 | 31.1 ±25.8 (−42.3) | 49.7 ± 28.8 | 23.9 ± 27.0 (−32.5) | 0.018 (+30.1) |
| Total AUSCAN score† | 43.7 ± 28.2 | 23.5 ± 24.4 (−35.0) | 50.2 ± 27.3 | 16.8 ± 25.2 (−25.2) | 0.011 (+39.9) |
| Pain index* | 42.2 ± 28.7 | 24.1 ± 24.8 (−36.3) | 48.3 ± 27.4 | 18.5 ± 25.1 (−27.7) | 0.027 (+30.3) |
| Stiffness index† | 42.6 ±30.1 | 23.4 ± 27.3 (−35.4) | 50.4 ±30.1 | 16.2 ± 28.7 (−24.3) | 0.011 (+44.4) |
| Functional index†† | 44.7 ± 28.6 | 23.2 ± 25.4 (−37.4) | 50.8 ± 28.3 | 15.9 ± 26.1 (−23.8) | 0.01 (+45.9) |
| Global rating of disease†† | 37.5 ± 26.8 | 20.8 ± 27.1 (−36.1) | 41.9 ± 25.8 | 14.8 ± 28.1 (−26.2) | 0.06 (+40.5) |
|
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| Week 6 | |||||
|
| |||||
| OA pain intensity* | 39.9 ± 31.6 | 33.7 ± 27.8 (−45.8) | 46.9 ± 29.9 | 26.7 ± 28.0 (−36.3) | 0.023 (+26.2) |
| Total AUSCAN score† | 41.4 ± 28.8 | 25.9 ± 25.1 (−38.5) | 48.5 ± 28.1 | 18.6 ± 26.2 (−27.9) | 0.006 (+39.2) |
| Pain index* | 40.2 ± 29.1 | 26.1 ± 25.6 (−39.4) | 46.7 ± 28.7 | 20.1 ± 26.5 (−30.1) | 0.021 (+30.0) |
| Stiffness index† | 40.9 ± 31.1 | 25.2 ± 28.7 (−38.2) | 49.5 ± 28.1 | 17.2 ± 30.0 (−25.8) | 0.005 (+46.5) |
| Functional index†† | 42.0 ± 29.3 | 25.8 ± 26.1 (−38.0) | 48.9 ± 28.7 | 17.8 ± 26.9 (−26.7) | 0.005 (+44.9) |
| Global rating of disease†† | 35.2 ± 27.3 | 23.1 ± 27.0 (−40.1) | 40.4 ± 26.3 | 16.3 ± 28.0 (−28.8) | 0.023 (+41.7) |
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| Week 8 | |||||
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| OA pain intensity* | 38.1 ± 32.7 | 35.5 ± 28.9 (−48.2) | 44.0 ± 30.9 | 29.6 ± 29.5 (−40.2) | 0.06 (+19.9) |
| Total AUSCAN score† | 40.5 ± 29.9 | 26.7 ± 26.6 (−39.7) | 46.5 ± 28.7 | 20.5 ± 27.3 (−30.7) | 0.028 (+30.2) |
| Pain index* | 39.2 ± 30.1 | 27.2 ± 26.9 (−41.0) | 44.2 ± 29.5 | 22.5 ± 27.8 (−33.7) | 0.09 (+20.9) |
| Stiffness index† | 39.4 ± 32.1 | 26.6 ± 30.0 (−40.3) | 45.5 ± 31.4 | 21.1 ± 30.5 (−31.7) | 0.048 (+26.1) |
| Functional index†† | 41.4 ± 30.4 | 26.5 ± 27.6 (−39.0) | 47.5 ± 28.3 | 19.2 ± 28.0 (−28.8) | 0.017 (+38.0) |
| Global rating of disease†† | 34.2 ± 28.2 | 24.2 ± 28.1 (−42.0) | 37.9 ± 27.4 | 18.8 ± 29.2 (−33.3) | 0.11 (+28.7) |
↵* 0 = no pain, 100 = extreme pain.
↵† 0 = no pain/stiffness/difficulty, 100 = extreme pain/stiffness/difficulty.
↵†† 0 = very good, 100 = very poor.
↵§ Difference in least-squares mean for vehicle minus that for diclofenac sodium gel. AUSCAN: Australian/Canadian Osteoarthritis Hand Index; BL: baseline assessment; NS: not significant.