Secondary and other endpoints: clinical improvement, endoscopic improvement, histological healing and symptom resolution from baseline to week 8 (mITT population; n=410)
| Efficacy parameter | Placebo (n=89) n (%) | Budesonide MMX 9 mg, (n=109) n (%) | Budesonide MMX 6 mg, (n=109) n (%) | Entocort EC (n=103) n (%) |
|---|---|---|---|---|
| Clinical improvement | 30 (33.7) | 46 (42.2) | 28 (25.7) | 34 (33.0) |
| Endoscopic improvement | 28 (31.5) | 46 (42.2) | 28 (25.7) | 38 (36.9) |
| Histological healing | 6 (6.7) | 18 (16.5)* | 10 (9.2) | 14 (13.6) |
| Symptom resolution | 10 (11.2) | 26 (23.9)* | 15 (13.8) | 19 (18.4) |
*p<0.05.
mITT, modified intention to treat; MMX, Multi-Matrix System.