Table 1 Pharmacodynamic effects of lesogaberan 30, 90, 120 and 240 mg relative to placebo (efficacy analysis set; n = 25)
Lesogaberan dose (mg) | Difference in geometric mean (%) | 95% CI | p value* |
|---|---|---|---|
Total number of reflux episodes† | |||
30 | -26.2 | -12.7 to -37.6 | 0.0006 |
90 | -37.0 | -25.0 to -47.1 | < 0.0001 |
120 | -45.0 | -35.5 to -53.1 | < 0.0001 |
240 | -52.8 | -44.3 to -60.0 | < 0.0001 |
Number of reflux episodes in upright position | |||
30 | -25.2 | -11.1 to -37.1 | 0.0013 |
90 | -38.4 | -26.3 to -48.5 | < 0.0001 |
120 | -46.1 | -36.5 to -54.2 | < 0.0001 |
240 | -50.7 | -41.5 to -58.4 | < 0.0001 |
Number of reflux episodes in supine position | |||
30 | -37.3 | +2.0 to -61.5 | 0.0597 |
90 | -12.3 | +45.2 to -47.0 | 0.6042 |
120 | -31.2 | +9.3 to -56.7 | 0.1117 |
240 | -69.1 | -50.0 to -80.9 | < 0.0001 |
Number of acid reflux episodes† | |||
30 | -34.7 | +3.2 to -58.6 | 0.0677 |
90 | -45.5 | -12.3 to -66.1 | 0.0132 |
120 | -57.9 | -35.0 to -72.7 | 0.0002 |
240 | -57.1 | -32.5 to -72.7 | 0.0004 |
Number of weakly acid reflux episodes† | |||
30 | -28.3 | -7.5 to -44.5 | 0.0113 |
90 | -31.4 | -10.7 to -47.4 | 0.0059 |
120 | -44.5 | -29.2 to -56.4 | < 0.0001 |
240 | -45.1 | -29.3 to -57.3 | < 0.0001 |
Number of pure liquid reflux episodes† | |||
30 | -27.9 | +0.6 to -48.3 | 0.0540 |
90 | -53.0 | -33.6 to -66.7 | < 0.0001 |
120 | -44.1 | -23.3 to -59.2 | 0.0005 |
240 | -51.9 | -33.1 to -65.4 | < 0.0001 |
Number of mixed gas/liquid reflux episodes† | |||
30 | -25.0 | -5.1 to -40.7 | 0.0175 |
90 | -28.3 | -8.4 to -43.8 | 0.0084 |
120 | -42.5 | -28.1 to -54.0 | < 0.0001 |
240 | -56.7 | -45.4 to -65.7 | < 0.0001 |
Proximal extent of reflux (cm)† | |||
30 | -39.1 | -4.5 to -61.2 | 0.0312 |
90 | -58.9 | -34.4 to -74.2 | 0.0003 |
120 | -66.3 | -48.3 to -78.0 | < 0.0001 |
240 | -63.3 | -42.8 to -76.5 | < 0.0001 |
Proportion of time with esophageal pH < 4,%† | |||
30 | -69.8 | -27.3 to -87.4 | 0.0083 |
90 | -56.1 | +9.0 to -82.3 | 0.0752 |
120 | -65.7 | -21.1 to -85.1 | 0.0126 |
240 | -73.0 | -35.6 to -88.6 | 0.0037 |
Proportion of time with intragastric pH < 4,%† | |||
30 | +40.4 | +10.3 to +78.8 | 0.0066 |
90 | +23.7 | -3.8 to +58.9 | 0.0957 |
120 | +3.6 | -17.7 to +30.3 | 0.7625 |
240 | +27.7 | +0.6 to +62.1 | 0.0451 |