Table 4.
Overview of the total clinical symptoms score
| Week 1 (4th visit)
|
Week 2 (5th visit)
|
End of the study
|
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Placebo | SFPP
|
Placebo | SFPP
|
Placebo | SFPP
|
|||||||
| 10 mg | 20 mg | 40 mg | 10 mg | 20 mg | 40 mg | 10 mg | 20 mg | 40 mg | ||||
|
| ||||||||||||
| n | 126 | 121 | 126 | 130 | 124 | 120 | 125 | 129 | 127 | 121 | 127 | 134 |
| tCS * | ||||||||||||
| Baseline (3rd visit) | 12.1 ± 0.4 | 12.2 ± 0.4 | 11.7 ± 0.4 | 11.9 ± 0.4 | 12.0 ± 0.4 | 12.2 ± 0.4 | 11.7 ± 0.4 | 12.0 ± 0.4 | 12.1 ± 0.4 | 12.2 ± 0.4 | 11.8 ± 0.4 | 11.9 ± 0.4 |
| After treatment | 8.3 ± 0.4 | 8.2 ± 0.4 | 7.2 ± 0.3 | 7.1 ± 0.3 | 6.7 ± 0.4 | 6.7 ± 0.4 | 5.7 ± 0.3 | 5.4 ± 0.3 | 6.7 ± 0.4 | 6.7 ± 0.4 | 5.8 ± 0.3 | 5.5 ± 0.3 |
|
| ||||||||||||
| ΔtCS† | 3.7 (3.2−4.3) | 3.9 (3.3−4.4) | 4.7 (4.1−5.2) | 4.9 (4.3−5.4) | 5.3 (4.7−5.9) | 5.4 (4.8−6.0) | 6.1 (5.5−6.7) | 6.5 (6.0−7.1) | 5.3 (4.7−5.9) | 5.3 (4.7−5.9) | 6.1 (5.5−6.7) | 6.5 (5.9−7.0) |
| Difference between placebo† | – | 0.1 (−0.6–0.9) | 0.9 (0.2–1.7) | 1.1 (0.4–1.9) | – | 0.1 (−0.8–0.9) | 0.8 (−0.1–1.6) | 1.2 (0.4–2.0) | – | 0.0 (−0.8–0.9) | 0.8 (0.0–1.6) | 1.2 (0.4–2.0) |
| Comparisons with placebo: P-value‡ | – | 0.369 | 0.008 | 0.002 | – | 0.449 | 0.035 | 0.002 | – | 0.456 | 0.025 | 0.002 |
Notes:
*
Mean ± standard error.
†
Least squares mean (95% confidence interval).
‡
Analysis of covariance with the treatment group as a fixed effect and the baseline as a covariate (significance levels = 0.025 [one-sided]). End of the study means each patient’s last visit, which was the 5th visit or the visit when the application was stopped.
Abbreviations: SFPP, S-flurbiprofen plaster; tCS, total clinical symptoms score; ΔtCS, change in tCS from baseline.