WOMAC Subscale Score | Mean Change from Baseline (SD) | |||
---|---|---|---|---|
Week 2 | Week 6 | Week 9 | Week 12 | |
Pain | ||||
IDEA-033 | −1.21 (1.61) | −1.76 (1.88) | −1.85 (1.92) | −1.98 (1.97) |
TDT 064 | −1.46 (1.79) | −2.08 (1.94) | −2.20 (1.98) | −2.33 (2.12) |
MW = 0.4683 | MW = 0.4559 | MW = 0.4521 | MW = 0.4505 | |
p = 0.098 | p = 0.036 | p = 0.025 | p = 0.022 | |
Physical function | ||||
IDEA-033 | −1.28 (1.66) | −1.80 (1.95) | −1.93 (2.01) | −2.02 (2.07) |
TDT 064 | −1.51 (1.88) | −2.07 (2.01) | −2.18 (2.10) | −2.32 (2.23) |
MW = 0.4687 | MW = 0.4605 | MW = 0.4633 | MW = 0.4570 | |
p = 0.101 | p = 0.054 | p = 0.068 | p = 0.040 | |
Joint stiffness | ||||
IDEA-033 | −1.38 (1.84) | −1.96 (2.12) | −2.09 (2.19) | −2.23 (2.22) |
TDT 064 | −1.62 (2.08) | −2.21 (2.11) | −2.28 (2.17) | −2.48 (2.28) |
MW = 0.4648 | MW = 0.4608 | MW = 0.4713 | MW = 0.4655 | |
p = 0.076 | p = 0.055 | p = 0.121 | p = 0.080 |
WOMAC: Western Ontario and McMaster Universities Osteoarthritis Index; ITT: intent-to-treat; MW: Mann-Whitney estimators for IDEA-033 versus TDT 064; p values in favor of TDT 064 calculated using Wilcoxon-Mann-Whitney U test based on 1-sided 97.5% CI.