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
Placebo
Demographics
Age (years); median (range)
65.0 (43ā85)
66.0 (40ā87)
Sex; (%)
āMale
32 (23)
48 (32)
āFemale
106 (77)
101 (68)
Race; (%)
āCaucasian
138 (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; (%)
āLeft knee
51 (37)
50 (34)
āRight knee
54 (39)
58 (39)
āLeft hip
10 (7)
19 (13)
āRight hip
23 (17)
22 (15)
Baseline assessments
BPI; mean (SD)
āPain at its worst in the ālast 24āh
7.8 (1.23)1
7.8 (1.06)4
āPain at its least in the ālast 24āh
4.6 (1.57)1
4.5 (1.50)4
āPain on average
6.6 (1.04)1
6.5 (0.94)5
āPain right now
6.4 (1.49)1
6.2 (1.67)6
WOMAC OA Index; mean (SD)
āPain subscale
11.8 (2.63)2
11.5 (2.71)5
āFunctional impairment āsubscale
41.2 (9.25)1
39.8 (9.46)4
āStiffness subscale
4.6 (1.28)2
4.3 (1.44)4
āTotal score
17.7 (3.40)3
16.9 (3.90)5
SF-36; mean (SD)
āPain subscale
27.7 (10.84)2
27.8 (11.01)6
āPhysical functioning āsubscale
25.0 (12.57)1
27.8 (13.33)4
āSocial functioning āsubscale
52.1 (20.82)1
52.0 (21.28)4
āMental health āsubscale
58.5 (17.47)1
59.5 (18.32)4
āHealth transition āsubscale
44.0 (13.74)1
43.0 (14.86)5
MOS sleep subscale
āIndex I score
38.6 (17.43)1
35.7 (17.14)
āIndex II score
39.9 (17.08)1
37.2 (16.89)
1137 subjects; 2136 subjects; 3135 subjects; 4148 subjects; 5147 subjects; 6146 subjects., total number of subjects; SD, standard deviation; , number of subjects; BPI, brief pain inventory; h, hours; WOMAC OA, Western Ontario, and McMaster Universities Osteoarthritis; MOS, medical outcome study.