Table 3.
Study | Analysis | Treatment groupa | Responderb n (%) | P valuec |
---|---|---|---|---|
Study 1 | BOCF | DLX 60/120 mg QD | 50 (45.9) | 0.056 |
Placebo | 38 (33.0) | |||
LOCF | DLX 60/120 mg QD | 58 (53.2) | 0.060 | |
Placebo | 46 (40.0) | |||
mBOCF | DLX 60/120 mg QD | 52 (47.7) | 0.137 | |
Placebo | 43 (37.4) | |||
aeBOCF | DLX 60/120 mg QD | 53 (48.6) | 0.226 | |
Placebo | 46 (40.0) | |||
Study 2 | BOCF | DLX 60/120 mg QD | 69 (57.0) | 0.031 |
Placebo | 54 (42.5) | |||
LOCF | DLX 60/120 mg QD | 79 (65.3) | <0.001 | |
Placebo | 56 (44.1) | |||
mBOCF | DLX 60/120 mg QD | 72 (59.5) | 0.008 | |
Placebo | 54 (42.5) | |||
aeBOCF | DLX 60/120 mg QD | 72 (59.5) | 0.008 | |
Placebo | 54 (42.5) |
Study 1: N (DLX 60/120 mg QD) = 109, N (placebo) = 115.
Study 2: N (DLX 60/120 mg QD) = 121, N (placebo) = 127.
Response was defined as at least a 30% reduction in BPI average pain.
P value comparison with placebo.
Abbreviations: aeBOCF, discontinuation due to adverse events only; BOCF, baseline observation carried forward; BPI, Brief Pain Inventory; DLX, duloxetine; LOCF, last observation carried forward; mBOCF, modified BOCF; MMRM, mixed-model repeated measures; N, number of patients in the specified category; QD, once daily.