Table 1

NPSI total score and subscale score results (intent-to-treat population): DB maintenance phasea

Placebo (n = 124)Tapentadol ER (n = 137)
Evoked pain
 Mean (SD) score at start of DB phase2.43 (2.18)2.39 (2.23)
 Mean (SD) change at DB end point0.78 (2.64)0.16 (2.15)
 P value (minus placebo)b0.015
Paresthesia/dysesthesia
 Mean (SD) score at start of DB phase3.64 (2.69)3.81 (2.53)
 Mean (SD) change at DB end point1.29 (2.95)−0.01 (2.79)
 P value (minus placebo)b<0.001
Paroxysmal pain
 Mean (SD) score at start of DB phase2.90 (2.42)2.96 (2.32)
 Mean (SD) change at DB end point0.92 (3.02)0.12 (2.53)
P value (minus placebo)b0.009
Pressing pain
 Mean (SD) score at start of DB phase2.44 (2.22)2.50 (2.20)
 Mean (SD) change at DB end point1.03 (2.97)0.15 (2.29)
 P value (minus placebo)b0.010
Burning pain
 Mean (SD) score at start of DB phase3.11 (2.35)3.09 (2.55)
 Mean (SD) change at DB end point1.27 (3.07)0.26 (2.86)
 P value (minus placebo)b0.005
Total score
 Mean (SD) score at start of DB phase28.35 (19.98)28.82 (18.94)
 Mean (SD) change at DB end point10.10 (24.38)1.26 (19.80)
 P value (minus placebo)b<0.001
  • DB, double blind.

  • aResults are presented for all patients who had observations at both the start of the DB maintenance phase and at the end point of the DB maintenance phase.

  • bBased on an ANCOVA model with treatment, pooled analysis site, and dose category as factors and value at the start of the DB maintenance phase as a covariate.