Table 1.
Patient characteristics and baseline (safety population)
| Characteristics | Placebo | SK-1202 | p value* | ||
|---|---|---|---|---|---|
| 13 g/day | 26 g/day | 39 g/day | |||
| n = 62 | n = 63 | n = 63 | n = 62 | ||
| Sex, n (%) | |||||
| Male | 9 (14.5) | 9 (14.3) | 14 (22.2) | 8 (12.9) | 0.505a |
| Female | 53 (85.5) | 54 (85.7) | 49 (77.8) | 54 (87.1) | |
| Age, years | |||||
| Mean ± SD | 42.3 ± 11.6 | 39.4 ± 12.3 | 42.8 ± 12.7 | 43.1 ± 11.0 | 0.286b |
| BMI, kg/m2 | |||||
| Mean ± SD | 20.94 ± 3.19 | 21.47 ± 2.91 | 21.99 ± 3.99 | 21.55 ± 3.11 | 0.369b |
| Duration of constipation (months) | |||||
| Mean ± SD | 217.9 ± 143.7 | 198.5 ± 145.9 | 192.4 ± 135.9 | 187.0 ± 139.9 | 0.638b |
| History of treatment for constipation, n (%) | |||||
| No | 29 (46.8) | 42 (66.7) | 35 (55.6) | 31 (50.0) | 0.122a |
| Yes | 33 (53.2) | 21 (33.3) | 28 (44.4) | 31 (50.0) | |
| Constipation-predominant IBS, n (%) | |||||
| No | 55 (88.7) | 59 (93.7) | 60 (95.2) | 56 (90.3) | 0.500a |
| Yes | 7 (11.3) | 4 (6.3) | 3 (4.8) | 6 (9.7) | |
| The frequency of SBMs at baseline, time/week | |||||
| Mean ± SD | 1.47 ± 0.79 | 1.50 ± 0.74 | 1.57 ± 0.61 | 1.55 ± 0.64 | 0.831b |
SD standard deviation, BMI body mass index, IBS irritable bowel syndrome, SBM spontaneous bowel movement
*The two-sided level of significance is 15%
aFisher’s Exact Test
bOne-way ANOVA