Table 2

Efficacy end points (full analysis set)

End pointPlacebo (n=442)Acotiamide (n=450)p Value
Primary end point
 Overall treatment efficacy34.852.2<0.001
 Elimination rate for all three symptoms9.015.30.004
Secondary end point
 Elimination rate of individual symptoms at last survey point
  Postprandial fullness16.622.70.026
  Upper abdominal bloating28.534.50.084
  Early satiation25.437.8<0.001
  • Patients achieving the two primary overall efficacy end points: “extremely improved” or “improved” were considered responders.

  • Elimination rate: the proportion of patients who achieved elimination of all of the three symptoms: postprandial fullness, upper abdominal bloating and early satiation (no symptoms) at the last survey point.