Table 1.
Patient characteristics and baseline demographics (safety population)
| Characteristic | Revexepride 0.5 mg t.i.d. (n = 34) | Placebo (n = 31) | Total (n = 65) |
|---|---|---|---|
| Age, years, mean (SD) | 43.8 (16.04) | 45.8 (14.50) | 44.8 (15.24) |
| Sex, n (%) | |||
| Female | 19 (55.9) | 17 (54.8) | 36 (55.4) |
| BMI, kg/cm3, mean (SD) | 25.2 (3.78) | 26.4 (4.36) | 25.8 (4.07) |
| Helicobacter pylori infection*, n (%) | |||
| Yes | 9 (26.5) | 6 (19.4) | 15 (23.1) |
| No | 24 (70.6) | 24 (77.4) | 48 (73.8) |
| Unknown | 1 (2.9) | 1 (3.2) | 2 (3.1) |
| Reflux esophagitis, n (%) | |||
| Grade A | 11 (32.4) | 6 (19.4) | 17 (26.2) |
| Grade B | 3 (8.8) | 3 (9.7) | 6 (9.2) |
| History of GERD symptoms, months, mean (SD) | 128.8 (127.09) | 102.7 (82.24) | 116.3 (108.03) |
| Did PPI therapy provide relief? n (%) | |||
| Not at all | 5 (14.7) | 6 (19.4) | 11 (16.9) |
| A little bit | 11 (32.4) | 18 (58.1) | 29 (44.6) |
| Somewhat | 10 (29.4) | 5 (16.1) | 15 (23.1) |
| Quite a bit | 6 (17.6) | 2 (6.5) | 8 (12.3) |
| Very much | 2 (5.9) | 0 | 2 (3.1) |
*
Determination of H. pylori infection based on medical history only. BMI, body mass index; GERD, gastro-esophageal reflux disease; PPI, proton pump inhibitor; SD, standard deviation; t.i.d., three times daily.