Table 3.
Secondary Efficacy End Points: Mean change in Lanza score, Heartburn score and number of erosions.
| Visit | Test (N = 154) | Comparator (N = 76) | P – valueb |
|---|---|---|---|
| Lanza Score | |||
| Visit 1 (Baseline) | 0.610 ± 0.8805 | 0.618 ± 0.8789 | 0.9481 |
| Visit 5 (Week 12) | 0.577 ± 0.8713 | 0.750 ± 0.9457 | 0.1804 |
| Change from baseline to week 12 | −0.054 ± 0.7424 | 0.153 ± 0.7811 | 0.0581 |
| Visit 7 (Week 24) | 0.403 ± 0.7455 | 0.526 ± 0.8714 | 0.2646 |
| Change from baseline to week 24 | −0.208 ± 0.7977a | −0.092 ± 0.9685 | 0.3691 |
| Heartburn score | |||
| Visit 1 (Baseline) | 0.325 ± 0.5098 | 0.447 ± 0.5265 | 0.0908 |
| Visit 5 (Week 12) | 0.235 ± 0.4554 | 0.303 ± 0.4624 | 0.2957 |
| Change from baseline to week 12 | −0.059 ± 0.5409 | −0.053 ± 0.5137 | 0.9340 |
| Visit 7 (Week 24) | 0.176 ± 0.3825 | 0.250 ± 0.4655 | 0.2646 |
| Change from baseline to week 24 | −0.111 ± 0.5201a | −0.105 ± 0.6018 | 0.1315 |
| Number of erosions | |||
| Visit 1 (Baseline) | 1.396 ± 2.4877 | 1.145 ± 2.0113 | 0.4119 |
| Visit 5 (Week 12) | 1.228 ± 2.9158 | 1.528 ± 2.6695 | 0.4629 |
| Change from baseline to week 12 | −0.215 ± 2.6523 | 0.528 ± 2.4551 | 0.0470 |
| Visit 7 (Week 24) | 0.968 ± 2.5754 | 1.474 ± 3.6276 | 0.2787 |
| Change from baseline to week 24 | −0.429 ± 2.0859a | 0.329 ± 3.2224 | 0.0648 |
Test: Fixed dose combination of Aspirin 150 mg and Pantoprazole 20 mg.
Comparator: Aspirin 150 mg.
Data expressed as mean ± SD.
P < 0.05 (based on Paired T test; as compared to baseline).
P values based on Un-paired T test.