| Mesalazine, 3 g once daily (n = 191) | Mesalazine, 1 g three times daily (n = 189) | p Value | |
| Male, n (%) | 94 (49.2) | 96 (50.8) | 0.7582† |
| Mean (SD) age, years | 41.8 (14.0) | 43.3 (13.8) | 0.2896‡ |
| Mean body mass index (SD) | 24.8 (4.6) | 25.0 (4.3) | 0.7599‡ |
| Caucasian, n (%) | 189 (99.0) | 189 (100.0) | 0.1584‡ |
| Smoking status, n (%) | 0.9781† | ||
| Current smoker | 18 (9.4) | 19 (10.1) | |
| Non-smoker | 133 (69.6) | 131 (69.3) | |
| Former smoker | 40 (20.9) | 39 (20.6) | |
| Diagnosis, n (%) | 0.8618† | ||
| New diagnosis | 50 (26.2) | 48 (25.4) | |
| Established disease | 141 (73.8) | 141 (74.6) | |
| Median time since diagnosis, years (range) | 2.8 (0.1–36.5) | 3.1 (0.0–34.2) | 0.3915§ |
| Course of the established disease, n (%) | 0.5552† | ||
| Chronically active disease | 5 (3.5) (n = 141) | 7 (5.0) (n = 141) | |
| Relapsing disease | 136 (96.5) (n = 141) | 134 (95.0) (n = 141) | |
| Mean number of previous episodes/relapses (relapsing disease) (SD) | 4.3 (5.2) (n = 135) | 5.1 (5.2) (n = 132) | 0.2004‡ |
| Median duration of present acute episode (relapsing disease), days (range) | 27.0 (2–428) (n = 136) | 29.5 (2–275) (n = 134) | 0.5385§ |
| Disease localisation, n (%) | 0.1703† | ||
| Distal disease | 97 (50.8%) | 100 (52.9%) | |
| Proctosigmoiditis | |||
| Proximal disease | 94 (49.2%) | 89 (47.1%) | |
| Left-sided colitis | 55 (28.8%) | 40 (21.2%) | |
| Subtotal-/pancolitis | 39 (20.4%) | 49 (25.9%) | |
| Mean length of inflammation, cm (SD) | 49.1 (27.5) (n = 176) | 49.5 (25.3) (n = 177) | 0.8948‡ |
| Mean disease activity (SD) | |||
| Clinical activity index | 8.1 (2.2) | 7.9 (2.2) | 0.5593‡ |
| Modified disease activity index | 7.4 (1.7) | 7.0 (1.7) | 0.0356‡ |
| Endoscopic index | 7.5 (1.9) | 7.4 (1.9) | 0.5149‡ |
| Disease severity, n (%) | 0.5697† | ||
| Mild (CAI⩽8) | 121 (63.4) | 125 (66.1) | |
| Moderate (CAI>8) | 70 (36.6) | 64 (33.9) | |
| Pre-study maintenance medication*, n (%) | 94 (69.1) (n = 136) | 89 (66.4) (n = 134) | 0.6351† |
| Oral 5-aminosalicylate | 59 (43.4) | 53 (39.6) | |
| Oral sulfasalazine | 26 (19.1) | 26 (19.4) | |
| Rectal 5-aminosalicylate | 10 (7.4) | 9 (6.7) | |
| Immunosuppressants | 3 (2.2) | 1 (0.7) | |
| Oral corticosteroids | 2 (1.5) | 1 (0.7) |
Disease activity index with modified mucosal subscore (mucosal friability moved from a score of 1 to a score of 2).
*Doses of the pre-study medication did not violate the exclusion criterion. †χ2 test, two-sided. ‡t test, two-sided. §Wilcoxon rank-sum test, t approximation, two-sided.
CAI, clinical activity index; SD, standard deviation.