Table 7.
Response | Visits | Robenacoxib (s.c. + oral) | Meloxicam s.c. + oral placebo | P value (Mann–Whitney test) | Quotient robenacoxib:meloxicam (RMANCOVA) | P value (RMANCOVA) | Transformation for RMANCOVA analysis | ||
---|---|---|---|---|---|---|---|---|---|
Mean (SD) | Mean (SD) | Mean | 95% CI | Exponential | P value for normality (Shapiro-Wilks test) | ||||
Global investigator score (primary end point) | V5 | 1.86 (1.61) | 1.98 (1.91) | 0.93 | 0.968 | 0.682–1.316 | 0.84 | 0 (log) | 0.53 |
Posture | V5 | 0.70 (0.68) | 0.78 (0.74) | 0.72 | 1.007 | 0.527–1.693 | 0.98 | −1 (reciprocal) | <0.0001 |
Behaviour | V5 | 0.42 (0.59) | 0.54 (0.84) | 1.0 | 1.064 | 0.565–1.786 | 0.82 | −0.5 (reciprocal of square root) | <0.0001 |
Pain on palpation/manipulation | V5 & VF | 0.44 (0.62) | 0.52 (0.84) | 0.65 | 1.032 | 0.768–1.343 | 0.82 | 0.5 (square root) | <0.0001 |
Overall pain control | V5 & VF | 0.76 (0.62) | 0.76 (0.71) | 0.49 | 1.143 | 0.807–1.567 | 0.42 | 0.5 (square root) | <0.0001 |
Inflammation intensity | VF | 0.15 (0.04) | 0.25 (0.06) | 0.16 | 1.642 | 0.752–3.695 | 0.18 | 0 (log) | <0.0001 |
CI: confidence interval; s.c.: subcutaneous; VF: final visit.
Values are mean (SD) for each group and quotient values with 95% CI for the ratio robenacoxib/meloxicam. Data are from assessments at V5 and VF.
Non-inferiority of robenacoxib versus meloxicam was concluded if the lower limit of the 95% CI was >0.75 (shown in bold). P values <0.05 are also shown in bold.
The global investigator score (the primary end point) ranged from 0 to 9. All other end points (secondary end points) ranged from 0 to 3.