Parameter and time point | Category | International trial | p Value* | North American trial | p Value* | ||
Placebo (n = 248) | Itopride (n = 261) | Placebo (n = 316) | Itopride (n = 304) | ||||
GPA† week 8 LOCF | Symptom free, n (%) | 34 (13.7) | 42 (16.1) | 0.82 | 21 (6.6) | 27 (8.9) | 0.45 |
Markedly improved, n (%) | 79 (31.9) | 76 (29.1) | 91 (28.8) | 88 (28.9) | |||
Slightly improved, n (%) | 51 (20.6) | 64 (24.5) | 86 (27.2) | 97 (31.9) | |||
Unchanged, n (%) | 66 (26.6) | 62 (23.8) | 105 (33.2) | 77 (25.3) | |||
Worse, n (%) | 18 (7.3) | 17 (6.5) | 13 (4.1) | 15 (4.9) | |||
Responder, n (%) | 113 (45.6) | 118 (45.2) | 112 (35.4) | 115 (37.8) | |||
Non-responder, n (%) | 135 (54.4) | 143 (54.8) | 204 (64.6) | 189 (62.2) | |||
LDQ questions 1 and 8‡ week 8 LOCF | Responder, n (%) | 183 (76.6) | 205 (80.4) | 0.31 | 215 (69.8) | 217 (73.8) | 0.32 |
Non-responder, n (%) | 56 (23.4) | 50 (19.6) | 93 (30.2) | 77 (26.2) | |||
LDQ Questions 1 and 8§ week 8 LOCF | Responder, n (%) | 126 (52.7) | 158 (62.0) | 0.04 | 138 (44.8) | 138 (46.9) | 0.54 |
Non-responder, n (%) | 113 (47.3) | 97 (38.0) | 170 (55.2) | 156 (53.1) |
*p Value from a Cochrane–Mantel–Haenzel test stratified by pooled site. †In order to be classified as a responder, patients had to be either symptom free or markedly improved according to the GPA. ‡Responders had to show improvement by 1 point with respect to the LDQ questions 1 (upper abdominal pain) or 8 (fullness), but no deterioration of the other one. §Responders had to show improvement by at least 2 points with respect to the LDQ questions 1 (upper abdominal pain) or 8 (fullness), but no deterioration of the other one.
GPA, global patient assessment of efficacy; LDQ, Leeds Dyspepsia Questionnaire; LOCF, last observation carried forward.