| Baseline characteristics | Placebo | Racecadotril | Total | |||
| Age | 41 | ±15 | 41 | ±15 | 41 | ±15 |
| Female % | 144 | (51.1) | 214 | (55.3) | 358 | (53.5) |
| Height (m) | 1.68 | ±0.09 | 1.67 | ±0.12 | 1.68 | ±0.11 |
| Weight (kg) | 67.17 | ±11.42 | 66.17 | ±12.39 | 66.59 | ±12.00 |
| BMI (kg/m2) | 23.73 | ±3.68 | 23.52 | ±3.72 | 23.61 | ±3.70 |
| Non-Caucasian ethnicity | (53) | 18.8% | (67) | 17.3% | (120) | 17.9% |
| Blood in stools | (11) | 3.9% | (10) | 2.6% | (21) | 3.1% |
| Waterly stool aspect | (262) | 92.9% | (347) | 89.7% | (609) | 91.0% |
| Work interruption | (92) | 38.0% | (151) | 43.1% | (243) | 41.0% |
| N of stools last 24 hours | 5.63 | ±2.21 | 5.78 | ±2.45 | 5.72 | ±2.35 |
| Anal burning | 59.2% | 55.8% | 57.2% | |||
| Anal contractures | 45.0% | 44.4% | 44.7% | |||
| Abdominal pain | 92.6% | 91.0% | 91.6% | |||
| Nausea | 62.8% | 66.3% | 64.8% | |||
| Vomiting | 29.5% | 24.5% | 26.6% | |||
| Appetite loss | 77.7% | 77.8% | 77.7% | |||
| Fatigue | 80.9% | 84.0% | 82.7% | |||
| Insomnia | 53.0% | 47.8% | 50.0% | |||
| Other symptoms | 2.8% | 1.0% | 1.8% | |||
| Pain and palpitation | 83.0% | 85.3% | 84.3% | |||
| Meteorism | 77.3% | 75.4% | 76.2% | |||
| Symptom score baseline | 0.75 | ±0.25 | 0.73 | ±0.20 | 0.74 | ±0.22 |
| CGI baseline | ||||||
| -Mild | (56) | 19.9% | (77) | 19.9% | (133) | 19.9% |
| -Moderate | (145) | 51.4% | (231) | 59.7% | (376) | 56.2% |
| -Severe | (81) | 28.7% | (79) | 20.4% | (160) | 23.9% |
| Number of stools/day | 5.63 | 2.21 | 5.78 | 2.45 | 5.72 | 2.35 |
| Total | (282) | 100.0% | (387) | 100.0% | (669) | 100.0% |