Patient characteristics (full-analysis set, N=146)*
| Parameter | Verum (n=72) | Placebo (n=74) |
| Age (years) | ||
| Arithmetic mean (SD) | 54.7 (13.5) | 58.2 (13.4) |
| Median (range) | 56.0 (22–78) | 61.0 (24–81) |
| Age group, years (n, %) | ||
| 18–30 | 6 (8.3) | 4 (5.4) |
| 31–40 | 7 (9.7) | 3 (4.1) |
| 41–50 | 8 (11.1) | 13 (17.6) |
| 51–64 | 33 (45.8) | 27 (36.5) |
| 65–74 | 15 (20.8) | 22 (29.7) |
| >74 | 3 (4.2) | 5 (6.8) |
| Sex (n, %) | ||
| Female | 46 (63.9) | 51 (68.9) |
| Body mass index (kg/m2) | ||
| Arithmetic mean (SD) | 27.9 (4.96) | 26.4 (4.95) |
| Median (range) | 27.1 (19.5–42.6) | 25.9 (17.6–39.2) |
| Common non-GI concomitant conditions, SOC (n, %)† | ||
| Vascular disorders | 25 (34.7) | 32 (43.2) |
| Musculoskeletal and connective tissue disorders | 17 (23.6) | 15 (20.3) |
| Metabolism and nutrition disorders | 15 (20.8) | 16 (21.6) |
*The full-analysis set includes all randomised patients who received the study drug at least once, and who provided any postbaseline data for the RDQ score used for responder analysis, and who did not violate against inclusion criteria.
†Concomitant diseases in at least 20% of the overall trial population.
GI, gastrointestinal; n/N, number of patients; RDQ, Reflux Disease Questionnaire; SOC, system organ class.