Table 5.
Diary card grittiness
| Period | Statistical measurement(s) | Time point | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Morning | Afternoon | Evening | Daily average | ||||||
| TOP1630 (N=31) | Placebo (N=30) | TOP1630 (N=31) | Placebo (N=30) | TOP1630 (N=31) | Placebo (N=30) | TOP1630 (N=31) | Placebo (N=30) | ||
| Baseline | n | 31 | 30 | 31 | 30 | 31 | 30 | 31 | 30 |
| Mean (SD) | 1.75 (1.16) | 2.07 (1.15) | 1.48 (1.01) | 1.55 (0.10) | 1.51 (1.06) | 1.56 (0.92) | 1.58 (1.03) | 1.74 (0.97) | |
| Mean Δa | −0.32 | – | −0.07 | – | −0.05 | – | −0.16 | – | |
| Day 15 to day 29 | n | 30 | 30 | 30 | 30 | 30 | 30 | 30 | 30 |
| Mean (SD) | 1.38 (1.06) | 1.95 (1.00) | 1.14 (0.87) | 1.61 (1.01) | 1.13 (0.87) | 1.61 (1.07) | 1.23 (0.89) | 1.74 (0.99) | |
| Mean Δa | −0.57 | – | −0.47 | – | −0.48 | – | −0.51 | – | |
| P-value (two-sample t-test) | 0.0354** | – | 0.0579* | – | 0.0651* | – | 0.0406** | – | |
| P-value (Wilcoxon rank sum test) | 0.0419** | – | 0.0870* | – | 0.0808* | – | 0.0717* | – | |
| Mean (SD) change from baseline | −0.37 (0.62) | −0.12 (0.53) | −0.34 (0.64) | 0.06 (0.36) | −0.38 (0.71) | 0.05 (0.48) | −0.32 (0.61) | 0.00 (0.38) | |
| Mean Δa | −0.21 | – | −0.37 | – | −0.39 | – | −0.31 | – | |
| P-value (two-sample t-test) | 0.1680 | – | 0.0071** | – | 0.0164** | – | 0.0186** | – | |
| P-value (ANCOVA model) | 0.0374** | – | 0.0028** | – | 0.0088** | – | 0.0062** | – | |
Notes: N in the headers represents the total number of subjects in each respective treatment group within the mITT population. Symptom score was assessed on a 0–5 scale; 0.5 increments were not allowed. Lower score indicates less symptomatology. Baseline was defined as the average of all days during the run-in period. Daily scores were obtained by averaging the morning, afternoon, and evening scores for that day.
a
TOP1630 value minus placebo value.
*
P<0.1;
**
P<0.05.
Abbreviations: ANCOVA, analysis of covariance; ∆, difference; mITT, modified intent-to-treat.