Table 2 Secondary endpoints at Week 13 (double-blind treatment period; LOCF analysis)
LS means for change from baseline (SE) | |||||||
|---|---|---|---|---|---|---|---|
double-blind treatment period | Open-label treatment period | Acute + Open-label | |||||
Placebo (n = 93) | Duloxetine (n = 91) | Treatment difference | p-value | Placebo/duloxetine (n = 75) | Duloxetine/duloxetine (n = 74) | All patients randomized to duloxetine (n = 90)a | |
BPI Severity and Interference Ratings | |||||||
Worst pain score | −0.96 (0.267) | −1.43 (0.275) | − 0.47 | 0.175 | − 0.8 (0.256)** | − 0.65 (0.262)* | − 1.66 (0.342)** |
Least pain score | − 0.60 (0.242) | − 0.96 (0.247) | − 0.35 | 0.255 | − 0.45 (0.212)* | −0.29 (0.218) | − 0.86 (0.267)** |
Pain score right now | − 1.17 (0.270) | − 1.44 (0.276) | − 0.26 | 0.446 | − 0.29 (0.252) | − 0.38 (0.259) | −1.31 (0.312)** |
Incidence of Treatment Responseb, n (%) | |||||||
≥30% Reduction | 33 (36.26) | 47 (52.22) | – | 0.032† | 27 (37.50) | 25 (36.23) | 49 (54.44) |
≥50% Reduction | 22 (24.18) | 36 (40.00) | – | 0.029† | 18 (25.00) | 17 (24.64) | 44 (48.89) |
BPI interference | |||||||
General activity | −0.99 (0.273) | −1.75 (0.280) | − 0.76 | < 0.030* | − 0.20 (0.229) | − 0.18 (0.233) | − 1.74 (0.316)** |
Mood | − 1.54 (0.273) | − 1.97 (0.279) | −0.43 | 0.220 | −0.25 (0.258) | − 0.15 (0.270) | −1.59 (0.330)** |
Walking ability | −1.21 (0.266) | −1.20 (0.271) | 0.01 | 0.966 | −0.21 (0.253) | −0.24 (0.260) | − 0.92 (0.285)** |
Normal work | −1.19 (0.281) | −1.41 (0.286) | − 0.22 | 0.545 | −0.32 (0.226) | − 0.62 (0.231)** | − 1.69 (0.328)** |
Relations with other people | − 1.07 (0.236) | − 1.83 (0.241) | − 0.77 | 0.013* | − 0.41 (0.222) | − 0.12 (0.229) | −1.53 (0.264)** |
Sleep | −1.16 (0.344) | −1.28 (0.352) | −0.12 | 0.788 | −0.54 (0.284) | − 0.63 (0.292)* | − 1.67 (0.417)** |
Enjoyment of life | −1.51 (0.251) | − 1.83 (0.257) | −0.32 | 0.320 | −0.26 (0.236) | − 0.25 (0.243) | − 1.76 (0.288)** |
School work | − 1.00 (0.324) | −1.48 (0.330) | − 0.49 | 0.243 | −0.06 (0.271) | − 0.59 (0.278)* | − 1.94 (0.362)** |
BPI average interference score | − 1.21 (0.217) | − 1.60 (0.221) | −0.39 | 0.165 | −0.32 (0.187) | − 0.30 (0.192) | −1.61 (0.264)** |
PPQ score | |||||||
Average pain score | −9.41 (2.946) | −11.03 (2.982) | −1.62 | 0.669 | −6.44 (3.296) | −10.65 (3.080)** | − 18.01 (3.523)** |
Worst pain score | −8.46 (3.322) | −14.36 (3.367) | −5.90 | 0.169 | −8.06 (3.677)* | −4.15 (3.427) | −15.96 (3.954)** |
Pain score right now | −7.20 (3.065) | −8.99 (3.092) | −1.79 | 0.647 | −6.34 (3.335) | −4.74 (3.075) | −8.40 (3.441)* |
CGI-S: Score | |||||||
Overall | −0.66 (0.118) | −0.88 (0.121) | − 0.22 | 0.146 | − 0.67 (0.121)** | −0.67 (0.125)** | −1.25 (0.145)** |
Mental Illness | −0.15 (0.087) | −0.16 (0.089) | − 0.01 | 0.927 | − 0.24 (0.101)* | −0.20 (0.104) | − 0.27 (0.127)* |
FDI total score | |||||||
Child total score | −5.00 (1.021) | −3.97 (1.038) | 1.03 | 0.431 | −1.03 (1.267) | −1.71 (1.202) | −5.02 (1.176)** |
Parent total score | −4.17 (1.139) | −3.25 (1.152) | 0.92 | 0.529 | −2.27 (1.327) | −3.49 (1.227)** | −5.36 (1.280)** |
CDI total score | −2.45 (0.674) | −3.28 (0.682) | −0.83 | 0.335 | −1.41 (0.681)* | −0.42 (0.703) | −3.36 (0.865)** |
MASC total score | −4.99 (1.558) | −6.21 (1.575) | −1.21 | 0.540 | −0.78 (1.432) | −0.55 (1.478) | −6.90 (2.299)** |