Placebo (n = 124) | Tapentadol ER (n = 137) | |
---|---|---|

Evoked pain | ||

Mean (SD) score at start of DB phase | 2.43 (2.18) | 2.39 (2.23) |

Mean (SD) change at DB end point | 0.78 (2.64) | 0.16 (2.15) |

P value (minus placebo)^{b} | 0.015 | |

Paresthesia/dysesthesia | ||

Mean (SD) score at start of DB phase | 3.64 (2.69) | 3.81 (2.53) |

Mean (SD) change at DB end point | 1.29 (2.95) | −0.01 (2.79) |

P value (minus placebo)^{b} | <0.001 | |

Paroxysmal pain | ||

Mean (SD) score at start of DB phase | 2.90 (2.42) | 2.96 (2.32) |

Mean (SD) change at DB end point | 0.92 (3.02) | 0.12 (2.53) |

P value (minus placebo)^{b} | 0.009 | |

Pressing pain | ||

Mean (SD) score at start of DB phase | 2.44 (2.22) | 2.50 (2.20) |

Mean (SD) change at DB end point | 1.03 (2.97) | 0.15 (2.29) |

P value (minus placebo)^{b} | 0.010 | |

Burning pain | ||

Mean (SD) score at start of DB phase | 3.11 (2.35) | 3.09 (2.55) |

Mean (SD) change at DB end point | 1.27 (3.07) | 0.26 (2.86) |

P value (minus placebo)^{b} | 0.005 | |

Total score | ||

Mean (SD) score at start of DB phase | 28.35 (19.98) | 28.82 (18.94) |

Mean (SD) change at DB end point | 10.10 (24.38) | 1.26 (19.80) |

P value (minus placebo)^{b} | <0.001 |

DB, double blind.

↵

^{a}Results 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.↵

^{b}Based 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.