Endpoint | Study | LIN 290 μg/day (%) | Placebo (%) | Delta |
12-week abdominal pain/discomfort responder rate: Patients with ≥30% improvement from baseline in either abdominal pain or discomfort (with neither getting worse) for ≥50% of the treatment period | Phase 2b (Study 202) N = 169 | 68 | 45 | 23 (P < P <00.001) |
Phase 3 (Trial 302) N = 804 | 54.11 | 38.46 | 15.65 ( P < P <00.0001) | |
Phase 3 (Trial 31) N = 800 | 54.81 | 41.77 | 13.04 (P = P = 00.0002) | |
12-week IBS degree-of-relief responder rate: Patients who are ‘considerably relieved’ or ‘completely relieved’ (score ≤2/5) for ≥50% of the treatment period | Phase 2b (Study 202) N = 169 | 47 | 21 | 26 (P < P <00.0001) |
Phase 3 (Trial 302) N = 804 | 39.40 | 16.63 | 22.77 ( P < P <00.0001) | |
Phase 3 (Trial 31) N = 800 | 37.04 | 18.48 | 18.56 ( P < P <00.0001) |