Table 4.
Pharmacodynamic effects after Namisol® dosing. Treatment differences are given in estimated differences of least square means with 95% confidence intervals and P values (significant P values are shown in bold). Log transformed VAS (scores in mm + 2) are given in units (U)
| Panel | I (n=13) | II (n=9) | II (n=9) | II (n=9) |
|---|---|---|---|---|
| Parameter | 5.0 mg oral vs. 5.0 mg sublingual | 6.5 mg oral vs. placebo | 8.0 mg oral vs. placebo | 8.0 mg vs. 6.5 mg oral |
| Body sway (%) | 7.66 (−4.62, 21.53) | 22.06 (−1.05, 50.57) | 60.82 (29.46, 99.79) | 31.76 (6.53, 62.96) |
| P = 0.2037 | P = 0.0610 | P = 0.0003* | P = 0.0145* | |
| VAS Alertness (mm) | −0.3 (−2.0, 1.5) | −1.4 (−3.2, 0.4) | −2.7 (−4.5, −0.9) | −1.3 (−3.1, 0.5) |
| P = 0.7124 | P = 0.1161 | P = 0.0057* | P = 0.1390 | |
| VAS Mood (mm) | 0.8 (−0.1, 1.6) | 0.1 (−0.3, 0.5) | 0.2 (−0.2, 0.6) | 0.1 (−0.4, 0.5) |
| P = 0.0653 | P = 0.5357 | P = 0.3686 | P = 0.7815 | |
| VAS Calmness (mm) | 1.8 (0.1, 3.5) | 0.7 (−0.1, 1.4) | 0.5 (−0.2, 1.2) | −0.1 (−0.9, 0.6) |
| P = 0.0443* | P = 0.0665 | P = 0.1246 | P = 0.7080 | |
| VAS Feeling high (U) | 0.111 (−0.042, 0.265) | 0.229 (0.073, 0.384) | 0.256 (0.093, 0.418) | 0.027 (−0.129, 0.183) |
| P = 0.1347 | P = 0.0071* | P = 0.0044* | P = 0.7145 | |
| VAS External perception (U) | 0.037 (−0.017, 0.090) | 0.061 (0.002, 0.121) | 0.078 (0.019, 0.137) | 0.017 (−0.042, 0.076) |
| P = 0.1482 | P = 0.0446* | P = 0.0141* | P = 0.5507 | |
| VAS Internal perception (U) | 0.006 (−0.014, 0.026) | 0.013 (−0.003, 0.029) | 0.002 (−0.015, 0.019) | −0.011 (−0.028, 0.005) |
| P = 0.5247 | P = 0.1057 | P = 0.8312 | P = 0.1632 | |
| Heart rate (beats min–1) | 0.2 (−3.6, 4.0) | 5.3 (2.4–8.2) | 5.6 (2.7–8.5) | 0.3 (−2.7, 3.2) |
| P = 0.9261 | P = 0.0019* | P = 0.0014* | P = 0.8524 |
P-values indicated with an
*
are statistically significant values (α= 0.05).