Baseline demographic characteristics by treatment group (intent-to-treat population).
| Characteristic | Diclofenac Sodium Gel, n = 198 | Vehicle, n = 187 |
|---|---|---|
| Men, % | 23.2 | 23.0 |
| Race, % | ||
| White | 87.4 | 90.9 |
| Black | 5.6 | 2.1 |
| Asian | 1.5 | 0 |
| Other | 5.6 | 7.0 |
| Mean age ± SD, yrs | 63.6 ± 10.3 | 64.7 ± 9.6 |
| Range | 40–92 | 40–87 |
| Mean height ± SD, cm* | 165.0 ± 9.8 | 164.7 ± 10.1 |
| Mean weight ± SD, kg† | 76.6 ± 18.4 | 77.8 ± 20.0 |
| Mean BMI ± SD*†, kg/m2 | 28.0 ± 6.3 | 28.6 ± 6.5 |
| Range | 17.6–55.0 | 17.5–49.8 |
| Right-handed, % | 92.9 | 89.3 |
| Kellgren-Lawrence grade, % | ||
| 1 | 19.2 | 14.4 |
| 2 | 27.8 | 33.7 |
| 3 | 53.0 | 51.9 |
| Mean painful joints in dominant hand ± SD, n | 5.2 ± 2.5 | 5.3 ± 3.0 |
| Painful CMC-1 joint, % | 67.2 | 75.9 |
| Painful DIP/PIP (digits 2–3), % | 78.8 | 77.5 |
| Currently treating with NSAID | 54.5 | 48.7 |
↵* Baseline height and BMI measurements were not available for 1 patient in the diclofenac sodium gel group.
↵† Baseline weight and BMI measurements were not available for 1 patient in the vehicle group. BMI: body mass index; CMC-1: first carpometacarpal joint; DIP: distal interphalangeal joints; NSAID: nonsteroidal antiinflammatory drug; PIP: proximal interphalangeal joints.