Table 1

Baseline demographics

CharacteristicFull analysis set
Esomeprazole 20 mg (n=330)Placebo
(n=321)
Age (years)
 Mean (SD)42.7 (13.1)44.4 (13.0)
Female, n (%)190 (57.6)177 (55.1)
Race, n (%)
 White208 (63.0)219 (68.2)
 Black/African-American112 (33.9)99 (30.8)
 Asian0 (0)1 (0.3)
 Native Hawaiian/Pacific Islander1 (0.3)0 (0)
 American Indian/Alaskan native4 (1.2)0 (0)
 Other5 (1.5)2 (0.6)
Run-in days with heartburn, mean (SD)
 Full analysis set5.7 (1.8)5.8 (1.8)
 More frequent*†7.0 (1.0)7.0 (1.0)
 Less frequent‡§4.0 (1.0)3.9 (1.0)
Run-in heartburn intensity score, mean (SD)
 Full analysis set1.1 (0.48)1.1 (0.52)
 More frequent*†1.4 (0.42)1.4 (0.46)
 Less frequent‡§0.8 (0.30)0.7 (0.30)
  • *More frequent heartburn defined as 6 or more days of heartburn during the run-in period.

  • †Esomeprazole: n=185; placebo: n=191.

  • ‡Less frequent heartburn defined as fewer than 6 days of heartburn during the run-in period.

  • §Esomeprazole: n=145; placebo: n=130.