|
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.
