Study period | Group | Percentage of heartburn-free days, mean (SE) | Heartburn-free days, n* | Adjusted mean (SE) change from baseline in percentage of heartburn-free days | P value for difference between groups† | |
In time period | Per week | |||||
Run-in‡ | ESO 20 mg | 20.1 (1.2) | 1.4 | 1.4 | – | – |
Placebo | 20.0 (1.3) | 1.4 | 1.4 | – | ||
Days 1–4 | ESO 20 mg | 43.1 (2.1) | 1.7 | 3.0 | 24.9 (1.8) | <0.001 |
Placebo | 29.0 (1.9) | 1.2 | 2.0 | 10.8 (1.8) | ||
Days 5–14 | ESO 20 mg | 50.8 (2.1) | 5.1 | 3.6 | 32.5 (1.6) | <0.001 |
Placebo | 32.4 (1.8) | 3.2 | 2.3 | 14.3 (1.6) |
*The number of heartburn-free days per period and week was calculated by multiplying the percentage of heartburn-free time by the number of days in the period (4, 7 or 10 days, respectively).
†Statistical comparison based on percentage of heartburn-free days.
‡A 7-day run-in period was planned for both studies; however, the actual run-in period varied between subjects. For the run-in period, the percentage of heartburn-free days was calculated using all available data. The number of heartburn-free days was calculated by multiplying the percentage of heartburn-free days by 7.
ESO, esomeprazole.