RDQ scores at baseline and end of treatment (full-analysis set, N=146)*
| RDQ score (mean (SD)) | Verum (n=72) | Placebo (n=74) | ANCOVA† Results (estimate (95% CI), p value) |
| Heartburn | |||
| Baseline | 13.56 (3.32) | 12.59 (3.22) | −2.33 (−3.58 to −1.08), 0.0003 |
| After 6 weeks | 4.43 (4.47) | 6.26 (5.42) | |
| Change from baseline | 9.17 (4.82) | 6.33 (5.07) | |
| Regurgitation | |||
| Baseline | 9.38 (5.54) | 9.30 (5.67) | −1.08 (−2.23 to 0.08), 0.0676 |
| After 6 weeks | 4.03 (5.18) | 5.04 (5.00) | |
| Change from baseline | 5.47 (6.06) | 4.17 (5.52) | |
| Dyspepsia | |||
| Baseline | 10.07 (5.03) | 8.87 (5.56) | −1.00 (−2.27 to 0.26), 0.1194 |
| After 6 weeks | 4.43 (4.47) | 6.26 (5.42) | |
| Change from baseline | 6.09 (5.97) | 3.81 (5.75) | |
| Total score‡ | |||
| Baseline | 33.00 (10.90) | 30.76 (11.59) | −4.54 (−7.69 to −1.39), 0.0050 |
| After 6 weeks | 12.41 (12.60) | 16.39 (12.74) | |
| Change from baseline | 20.65 (14.04) | 14.31 (12.83) | |
*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.
†ANCOVA (baseline as covariate) verum versus placebo for change from baseline.
‡Sum score of the three dimensions (max. 60 points).
ANCOVA, analysis of covariance; CI, confidence interval; n/N, number of patients; RDQ, Reflux Disease Questionnaire.