Table 1.
Patient demographics and baseline HRQL.
| Clinical Trial 1 | Clinical Trial 2 | Clinical Trial 3 | |
| N | 316 | 685 | 251 |
| Male% | 43% | 38% | 39% |
| Caucasian% | 89% | 69% | 91% |
| Age, mean (s.d.) | 45.5 (13.0) | 47.9 (14.1) | 45.1 (14.1) |
| Omeprazole% | 49% | 50% | 52% |
| Heartburn Severity%1 | |||
| None/Minor | 21% | 37% | 17% |
| Mild | 53% | 34% | 8% |
| Moderate | 20% | 24% | 36% |
| Severe | 4% | 5% | 39% |
| Missing | 2% | 0% | 0% |
| Heartburn-related symtoms2 | 3.1 (0.8) | 3.9 (1.0) | 4.5 (1.8) |
| PGWB Total, mean (s.d.) | 76.3 (16.4) | 73.0 (18.2) | 58.0 (21.8) |
| MOS Sleep, mean (s.d.) | 67.7 (25.7) | NA | 55.5 (29.2) |
1Based on the diary data, all patients randomized in Phase 2 of Clinical Trial 1 had at least one episode of moderate to severe heartburn (Phase 2 enrollment criteria). Patient responses to the GSRS heartburn item varied compared to the diary data. Hence, a proportion of the population is indicated as having heartburn (during the week previous to the baseline assessment) that was of less than moderate discomfort. 2GSRS heartburn item (1–7) scale for Clinical Trials 1 and 3 and heartburn item (1–6 scale) for Clinical Trial 2.