Table 2.
Placebo(N = 252) | Prucalopride(N = 249) | P value* | |
---|---|---|---|
Primary efficacy endpoint | |||
Responders, n (%) | 26 (10.3) | 83 (33.3) | <0.001 |
Subgroups, n/N (%) | |||
Race | |||
Asian | 25/231 (10.8) | 78/232 (33.6) | <0.001 |
Non-Asian | 1/21 (4.8) | 5/17 (29.4) | 0.031 |
Gender | |||
Female | 24/223 (10.8) | 77/227 (33.9) | <0.001 |
Male | 2/29 (6.9) | 6/22 (27.3) | 0.022 |
Age group | |||
18–40 years | 11/107 (10.3) | 41/115 (35.7) | <0.001 |
41–65 years | 15/145 (10.3) | 42/134 (31.3) | <0.001 |
Previous treatment for constipation | |||
Not used | 13/75 (17.3) | 33/66 (50.0) | <0.001 |
Used and adequate | 1/40 (2.5) | 15/43 (34.9) | <0.001 |
Used and inadequate | 12/137 (8.8) | 35/140 (25.0) | <0.001 |
SCBM, spontaneous complete bowel movement.
Levels of significance: prucalopride vs placebo.