A Phase IIIb, Multicentre, Randomised, Parallel-Group, Placebo-Controlled, Double-Blind Study to Investigate the Efficacy and Safety of OROS Hydromorphone in Subjects with Moderate-to-Severe Chronic Pain Induced by Osteoarthritis of the Hip or the Knee

Table 2

Primary and secondary efficacy variables in the HOP trial: mean (standard deviation) change from baseline to end of maintenance phase (ITT population).

	OROS hydromorphone 𝑁=138	Placebo 𝑁=149
BPI
Pain on average	–2.4 (2.1)^1	–2.6 (2.3)^5
Pain at its worst in the last 24 h	–2.4 (2.5)^1	–2.7 (2.6)^5
Pain at its least in the last 24 h	–1.7 (2.2)^1	–1.6 (2.6)^5
Pain right now	–2.6 (2.6)^1	–2.4 (2.7)^6
WOMAC OA Index
Pain subscale	–3.74 (4.49)^2	–3.86 (4.52)^5
Functional impairment  subscale	–11.93 (13.17)^1	–11.90 (14.35)^6
Stiffness subscale	–1.37 (1.85)^2	–1.22 (1.84)^6
Total score	–5.36 (5.99)^3	–5.16 (6.15)^5
SF-36 pain subscale	17.50 (20.48)^4	19.47 (23.50)^7
HRQoL
Physical functioning subscale	13.59 (19.71)^1	14.72 (24.08)^6
Social functioning subscale	7.29 (23.42)^1	9.55 (24.11)^6
MOS Sleep Subscale
Index I score	–5.77 (17.45)^1	–5.65 (14.30)^6
Index II score	–6.20 (16.81)^1	–6.98 (14.43)^6

¹132 subjects; ²131 subjects; ³130 subjects; ⁴129 subjects; ⁵143 subjects; ⁶144 subjects; ⁷142 subjects. BPI, brief pain inventory; h, hour; WOMAC OA, Western Ontario and McMaster Universities Osteoarthritis; HRQoL, health-related quality of life; MOS, medical outcome study.