TABLE 2.
Summary of efficacy results (full‐analysis set)
| Parameters | Tegoprazan | Placebo | P‐value (vs placebo) | |
|---|---|---|---|---|
| 50 mg (n = 106) | 100 mg (n = 99) | (n = 99) | [tegoprazan 50 mg; 100 mg] | |
| Complete resolution of major symptoms (RDQ score) | ||||
| Week 4, n (%) | 45 (42.5) | 48 (48.5) | 24 (24.2) | [P = 0.0058; P = 0.0004]a |
| [Difference from placebo, n (%)] | [23 (18.3)] | [24 (24.3)] | ||
| Week 2, n (%) | 17 (16.0) | 23 (23.2) | 10 (10.1) | [P = 0.2091; P = 0.0264]a |
| [Difference from placebo, n (%)] | [7 (5.9)] | [13 (13.1)] | ||
| Complete resolution of heartburn (RDQ score) | ||||
| Week 4, n (%) | 66 (62.3) | 65 (65.7) | 43 (43.4) | [P = 0.0069; P = 0.0017]a |
| [Difference from placebo, n (%)] | [20 (18.9)] | [22 (22.3)] | ||
| Week 2, n (%) | 43 (40.6) | 42 (42.4) | 26 (26.3) | [P = 0.0303; P = 0.0166]a |
| [Difference from placebo, n (%)] | [17 (14.3)] | [16 (16.1)] | ||
| Complete resolution of regurgitation (RDQ score) | ||||
| Week 4, n (%) | 58 (54.7) | 60 (60.6) | 48 (48.5) | [P = 0.3722; P = 0.1736]a |
| [Difference from placebo, n (%)] | [10 (6.2)] | [12 (12.1)] | ||
| Complete resolution of dyspepsia (RDQ score) | ||||
| Week 4, n (%) | 67 (63.2) | 66 (66.7) | 64 (64.7) | [P = 0.8303; P = 0.7647]a |
| [Difference from placebo, n (%)] | [3 (−1.5)] | [2 (2.0)] | ||
| Proportion of heartburn‐free days, % (SD) | 67.6 (29.8) | 66.5 (29.1) | 56.7 (30.3) | [P = 0.0103; P = 0.0210]b |
| [Difference from placebo, %] | [10.9] | [9.8] | ||
Abbreviations: n, number of patients; SD, standard deviation.
a
Chi‐square test, the P‐values were adjusted for multiple comparisons (overall familywise type I error of 5%) by the Hochberg procedure.
b
Unpaired t test, the P‐values were adjusted for multiple comparisons (overall familywise type I error of 5%) by the Hochberg procedure.