Skip to main content

Table 4 Summary statistics of efficacy outcomes at baseline, weeks 2, 12, 24, and 52

From: Open-label phase 3 study of diclofenac conjugated to hyaluronate (diclofenac etalhyaluronate: ONO-5704/SI-613) for treatment of osteoarthritis: 1-year follow-up

  Baseline
Mean ± SD
Week 2
Mean ± SD
Week 12
Mean ± SD
Week 24
Mean ± SD
Week 52
Mean ± SD
  N = 166 N = 166 N = 162 N = 158 N = 157
Pain score 5.9 ± 1.2 4.9 ± 1.9 4.3 ± 2.2 3.9 ± 2.3 3.1 ± 2.3
Patient global assessment (mm) 54.8 ± 19.3 43.4 ± 21.7 36.3 ± 23.7 33.0 ± 22.7 24.9 ± 23.0
Physician global assessment (mm) 54.2 ± 15.5 41.6 ± 19.8 32.8 ± 20.7 31.2 ± 22.1 23.7 ± 21.6
SF-36a
 MCS 53.0 ± 8.4 NA 53.1 ± 9.5 53.7 ± 9.4 52.8 ± 9.2
 RCS 47.5 ± 13.3 NA 49.0 ± 11.7 49.8 ± 12.1 47.9 ± 12.5
 PCS 31.9 ± 11.1 NA 33.0 ± 12.1 33.9 ± 13.0 36.3 ± 12.4
EQ-5Da
 QOL score 0.73 ± 0.13 NA 0.77 ± 0.13 0.78 ± 0.14 0.78 ± 0.14
 VAS score 68.4 ± 15.6 NA 68.8 ± 18.0 70.9 ± 18.3 71.1 ± 18.6
Responderb, n (%) NA 49 (29.5) 76 (46.9) 91 (57.6) 108 (68.8)
  1. SF-36 Medical Outcomes Study Short-Form 36-Item Health Survey, MCS mental component summary, NA not applicable, RCS role/social component summary, PCS physical component summary, EQ-5D EuroQol 5 dimension, QOL quality of life, VAS visual analogue scale
  2. aLower score indicates more pain or functional disability, and higher score indicates less pain or functional disability. QOL assessment was not conducted at week 2
  3. bPatients with improvement in joint pain score from baseline of at least 30%