Table 2

Secondary efficacy end points at the end of the assessment phase (week 12), ITT population

Buprenorphine (n = 89)Placebo (n = 92)P value
Change from baseline in mean NRS score for least pain intensity*−2.17 (1.82)−1.14 (2.24)<0.05
Change from baseline in mean NRS score for worst pain intensity*−3.79 (2.32)−2.64 (2.83)<0.05
Change from baseline in mean NRS score for night pain intensity*−3.63 (2.48)−2.43 (2.78)<0.05
Mean categorical scale score for pain relief* (0 = complete relief, 5 = pain worse)1.74 (1.23)2.32 (1.35)<0.05
Change from baseline in NPSI scores for pain intensity
 Total pain intensity score*−22.50 (17.70)−20.10 (21.68)<0.05
 Burning spontaneous pain−3.09 (2.81)−2.53 (3.87)0.25
 Pressing spontaneous pain−1.74 (2.46)−1.54 (2.72)0.06
 Paroxymal pain*−2.12 (2.73)−1.96 (2.89)<0.05
 Evoked pain−1.91 (1.87)−1.87 (2.65)0.14
 Parathesia/dysthesia pain−2.98 (2.94)−2.50 (3.11)0.06
Proportion of patients obtaining at least 50% reductions in pain intensity from baseline at week 1234.820.7<0.05
Mean number of paracetamol 500 mg taken per day as rescue medication1.56 (2.22)1.77 (2.39)0.73
Change from baseline in mean DSIS*−3.53 (2.51)−2.38 (2.59)<0.05
Change from baseline in mean SF-MPQ
 Total score§−6.71 (7.28)−5.30 (8.53)0.09
 Sensory pain dimension§−5.68 (6.01)−4.56 (7.73)0.08
 Affective pain dimension§−2.00 (3.20)−1.62 (2.77)0.21
 Pain over past 7 days§−33.70 (24.44)−27.30 (30.45)0.06
 Current pain§−1.02 (1.09)−0.64 (1.09)0.07
Change from baseline in mean interference by pain on
 General activity§−1.85 (2.96)−1.89 (2.79)0.17
 Mood−1.39 (2.57)−1.89 (2.75)0.96
 Walking ability−1.73 (2.69)−1.66 (3.12)0.18
 Normal work§−1.65 (2.66)−1.39 (2.55)0.12
 Relationships−0.61 (2.23)−1.00 (2.59)0.84
 Sleep−3.52 (2.87)−2.18 (3.07)<0.05
 Enjoyment of life§−2.48 (2.82)−2.11 (2.82)0.11
Change from baseline in affective state BDI-II total score−1.79 (7.64)−3.93 (6.01)0.36
Change from baseline in affective state POMS
 Total score−3.40 (26.71)−6.61 (21.92)0.57
 Tension/anxiety−0.66 (5.52)−0.99 (4.03)0.36
 Depression0.02 (8.62)−1.66 (6.90)0.35
 Anger/hostility§−0.60 (4.81)−0.35 (5.84)0.10
 Vigor/activity1.02 (5.74)1.66 (5.51)0.58
 Fatigue/inertia−1.08 (6.06)−1.23 (5.60)0.51
 Confusion/bewilderment−0.06 (3.33)−0.72 (2.76)0.73
Change from baseline in HRQOL (SF-36)
 Physical functioning2.72 (13.99)1.22 (16.07)0.21
 Role physical6.45 (37.04)4.93 (35.01)0.53
 Bodily pain17.26 (19.43)10.00 (20.56)<0.05
 General health5.00 (17.01)48.30 (23.51)0.21
 Vitality4.44 (16.84)4.58 (17.96)0.88
 Social functioning5.44 (27.03)2.46 (19.44)0.84
 Role emotional2.69 (44.48)−1.41 (36.27)0.14
 Mental health2.23 (16.69)5.52 (14.74)0.37
PGIC scale2.37 (1.09)3.03 (1.35)<0.05
CGIC scale2.39 (1.19)2.91 (1.21)0.25
  • Data are mean (SD) unless otherwise indicated. BDI-II, Beck Depression Inventory-II; POMS, Profile of Mood States; SF-36, 36-Item Short Form.

  • *Significantly superior for buprenorphine for weeks 1–12 (data not shown).

  • †Significantly superior for buprenorphine at weeks 2–6 (data not shown).

  • ‡Significantly superior for buprenorphine at all weeks except 4 and 12 (data not shown).

  • §Significantly superior for buprenorphine at week 6 (data not shown).