Summary of secondary efficacy outcomes
First treatment | Repeated treatment* | |||||
---|---|---|---|---|---|---|
Tegaserod (n = 2135) | Placebo (n = 525) | p Value | Tegaserod (n = 488) | Placebo (n = 495) | p Value | |
*Includes only first treatment tegaserod patients who received repeated treatment. | ||||||
†Of ⩾1 point in daily scores compared with baseline. | ||||||
‡p<0.05 by this day and beyond. | ||||||
Improvement† in abdominal discomfort/pain | 52.5% | 42.8% | <0.0001 | 54.2% | 41.8% | <0.0001 |
Statistically significant difference tegaserod v placebo reached by‡ | Day 3 | Day 3 | ||||
Improvement† in bloating | 50.6% | 40.1% | <0.0001 | 54.4% | 41.2% | <0.0001 |
Statistically significant difference tegaserod v placebo reached by‡ | Day 3 | Day 3 | ||||
Relief of constipation (75% rule) | 39.4% | 24.8% | <0.0001 | 45.1% | 27.5% | <0.0001 |
Mean stool consistency, change from baseline | –1.1 | –0.7 | <0.0001 | –0.9 | –0.6 | 0.0003 |
Statistically significant difference tegaserod v placebo reached by‡ | Day 1 | Day 1 | ||||
Weekly bowel movements, change from baseline | 2.5 | 1.3 | <0.0001 | 2.2 | 1.5 | 0.0013 |
Statistically significant difference tegaserod v placebo reached by‡ | Day 1 | Day 2 |