Abstract PTU-187 Table 1

Responder rates in Phase 2b/3 studies of LIN

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)