Clinical Study

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 1

Demographics and baseline assessments of subjects in the HOP trial (ITT population).

OROS hydromorphone š‘ = 1 3 8 Placebo š‘ = 1 4 9

Demographics
Age (years); median (range)65.0 (43ā€“85)66.0 (40ā€“87)
Sex; š‘› (%)
ā€ƒMale32 (23)48 (32)
ā€ƒFemale106 (77)101 (68)
Race; š‘› (%)
ā€ƒCaucasian138 (100)149 (100)
Weight (kg); mean (SD)84.4 (15.7)82.0 (15.6)
Height (cm); mean (SD)163.9 (9.6)165.9 (8.6)
Body mass index (kg/m2); mean (SD)31.5 (5.6)29.7 (5.0)
Most affected joint; š‘› (%)
ā€ƒLeft knee51 (37)50 (34)
ā€ƒRight knee54 (39)58 (39)
ā€ƒLeft hip10 (7)19 (13)
ā€ƒRight hip23 (17)22 (15)

Baseline assessments
BPI; mean (SD)
ā€ƒPain at its worst in the ā€ƒlast 24ā€‰h7.8 (1.23)17.8 (1.06)4
ā€ƒPain at its least in the ā€ƒlast 24ā€‰h4.6 (1.57)14.5 (1.50)4
ā€ƒPain on average6.6 (1.04)16.5 (0.94)5
ā€ƒPain right now6.4 (1.49)16.2 (1.67)6
WOMAC OA Index; mean (SD)
ā€ƒPain subscale11.8 (2.63)211.5 (2.71)5
ā€ƒFunctional impairment ā€ƒsubscale41.2 (9.25)139.8 (9.46)4
ā€ƒStiffness subscale4.6 (1.28)24.3 (1.44)4
ā€ƒTotal score17.7 (3.40)316.9 (3.90)5
SF-36; mean (SD)
ā€ƒPain subscale27.7 (10.84)227.8 (11.01)6
ā€ƒPhysical functioning ā€ƒsubscale25.0 (12.57)127.8 (13.33)4
ā€ƒSocial functioning ā€ƒsubscale52.1 (20.82)152.0 (21.28)4
ā€ƒMental health ā€ƒsubscale58.5 (17.47)159.5 (18.32)4
ā€ƒHealth transition ā€ƒsubscale44.0 (13.74)143.0 (14.86)5
MOS sleep subscale
ā€ƒIndex I score38.6 (17.43)135.7 (17.14)
ā€ƒIndex II score39.9 (17.08)137.2 (16.89)

1137 subjects; 2136 subjects; 3135 subjects; 4148 subjects; 5147 subjects; 6146 subjects. š‘ , total number of subjects; SD, standard deviation; š‘› , number of subjects; BPI, brief pain inventory; h, hours; WOMAC OA, Western Ontario, and McMaster Universities Osteoarthritis; MOS, medical outcome study.