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
Placebo
BPI
āPain on average
ā2.4 (2.1)1
ā2.6 (2.3)5
āPain at its worst in the last 24āh
ā2.4 (2.5)1
ā2.7 (2.6)5
āPain at its least in the last 24āh
ā1.7 (2.2)1
ā1.6 (2.6)5
āPain right now
ā2.6 (2.6)1
ā2.4 (2.7)6
WOMAC OA Index
āPain subscale
ā3.74 (4.49)2
ā3.86 (4.52)5
āFunctional impairment āsubscale
ā11.93 (13.17)1
ā11.90 (14.35)6
āStiffness subscale
ā1.37 (1.85)2
ā1.22 (1.84)6
āTotal score
ā5.36 (5.99)3
ā5.16 (6.15)5
SF-36 pain subscale
17.50 (20.48)4
19.47 (23.50)7
HRQoL
āPhysical functioning subscale
13.59 (19.71)1
14.72 (24.08)6
āSocial functioning subscale
7.29 (23.42)1
9.55 (24.11)6
MOS Sleep Subscale
āIndex I score
ā5.77 (17.45)1
ā5.65 (14.30)6
āIndex II score
ā6.20 (16.81)1
ā6.98 (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.