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 𝑁=138	Placebo 𝑁=149
Demographics
Age (years); median (range)	65.0 (43–85)	66.0 (40–87)
Sex; 𝑛 (%)
Male	32 (23)	48 (32)
Female	106 (77)	101 (68)
Race; 𝑛 (%)
Caucasian	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/m^2); mean (SD)	31.5 (5.6)	29.7 (5.0)
Most affected joint; 𝑛 (%)
Left knee	51 (37)	50 (34)
Right knee	54 (39)	58 (39)
Left hip	10 (7)	19 (13)
Right hip	23 (17)	22 (15)
Baseline assessments
BPI; mean (SD)
Pain at its worst in the  last 24 h	7.8 (1.23)^1	7.8 (1.06)^4
Pain at its least in the  last 24 h	4.6 (1.57)^1	4.5 (1.50)^4
Pain on average	6.6 (1.04)^1	6.5 (0.94)^5
Pain right now	6.4 (1.49)^1	6.2 (1.67)^6
WOMAC OA Index; mean (SD)
Pain subscale	11.8 (2.63)^2	11.5 (2.71)^5
Functional impairment  subscale	41.2 (9.25)^1	39.8 (9.46)^4
Stiffness subscale	4.6 (1.28)^2	4.3 (1.44)^4
Total score	17.7 (3.40)^3	16.9 (3.90)^5
SF-36; mean (SD)
Pain subscale	27.7 (10.84)^2	27.8 (11.01)^6
Physical functioning  subscale	25.0 (12.57)^1	27.8 (13.33)^4
Social functioning  subscale	52.1 (20.82)^1	52.0 (21.28)^4
Mental health  subscale	58.5 (17.47)^1	59.5 (18.32)^4
Health transition  subscale	44.0 (13.74)^1	43.0 (14.86)^5
MOS sleep subscale
Index I score	38.6 (17.43)^1	35.7 (17.14)
Index II score	39.9 (17.08)^1	37.2 (16.89)

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