Table 2.
Fexuprazan 40 mg
|
Esomeprazole 40 mg
|
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Baseline (n = 107)
|
Week 4 (n = 103)
|
Week 8 (n = 107)
|
Baseline (n = 111)
|
Week 4 (n = 104)
|
Week 8 (n = 111)
|
||
Frequency | |||||||
Heartburn | |||||||
mean ± SD | 1.92 ± 1.23 | 0.91 ± 1.37 | 0.86 ± 1.33 | 2.12 ± 1.42 | 0.80 ± 1.29 | 0.70 ± 1.28 | |
Change from baseline (mean ± SD) | - | -0.96 ± 1.50 | -1.06 ± 1.49 | - | -1.33 ± 1.69 | -1.42 ± 1.64 | |
P value1 | - | < 0.001w | < 0.001w | - | < 0.001w | < 0.001w | |
LS mean difference from esomeprazole | - | 0.19 | 0.22 | - | - | - | |
P value2 | - | 0.280 | 0.184 | - | - | - | |
Reflux | |||||||
mean ± SD | 2.14 ± 1.29 | 0.93 ± 1.48 | 0.92 ± 1.49 | 1.95 ± 1.29 | 0.61 ± 1.07 | 0.59 ± 1.12 | |
Change from baseline (mean ± SD) | - | -1.19 ± 1.58 | -1.22 ± 1.53 | - | -1.32 ± 1.44 | -1.36 ± 1.40 | |
P value1 | - | < 0.001w | < 0.001w | - | < 0.001w | < 0.001w | |
LS mean difference from esomeprazole | - | 0.28 | 0.28 | - | - | - | |
P value2 | - | 0.112 | 0.101 | - | - | - | |
Severity | |||||||
Heartburn | |||||||
mean ± SD | 1.81 ± 1.18 | 0.57 ± 0.78 | 0.53 ± 0.77 | 2.10 ± 1.24 | 0.45 ± 0.75 | 0.42 ± 0.79 | |
Change from baseline (mean ± SD) | - | -1.23 ± 1.26 | -1.28 ± 1.26 | - | -1.63 ± 1.29 | -1.68 ± 1.27 | |
P value1 | - | < 0.001w | < 0.001w | - | < 0.001w | < 0.001w | |
LS mean difference from esomeprazole | - | 0.16 | 0.16 | - | - | - | |
P value2 | - | 0.116 | 0.121 | - | - | - | |
Reflux | |||||||
mean ± SD | 2.06 ± 1.22 | 0.61 ± 0.92 | 0.58 ± 0.90 | 1.97 ± 1.21 | 0.40 ± 0.69 | 0.39 ± 0.73 | |
Change from baseline (mean ± SD) | - | -1.43 ± 1.23 | -1.48 ± 1.20 | - | -1.55 ± 1.23 | -1.58 ± 1.19 | |
P value1 | - | < 0.001w | < 0.001w | - | < 0.001w | < 0.001w | |
LS mean difference from esomeprazole | - | 0.20 | 0.18 | - | - | - | |
P value2 | - | 0.066 | 0.089 | - | - | - |
Testing for change within-treatment groups [paired t-test (t) or Wilcoxon signed rank test (w)].
Testing for difference between treatment groups (ANCOVA model with treatment group as a factor, baseline score and stratification factor (baseline LA classification) as covariates).
Note: If subjects did not have any RDQ assessment data by week 4, were treated as missing at week 4. RDQ: Reflux disease questionnaires; LS mean: Least square mean.