| Methods |
Double‐blind, double‐dummy, parallel‐group, randomized trial evaluating the efficacy and safety of MMX mesalazine dosed once daily (2.4 g/day) compared with Asacol (1.2 g twice daily) for the maintenance of clinical remission in patients with quiescent ulcerative colitis |
| Participants |
Adult patients (aged 18 to 75 years) in remission (modified UC‐DAI score of < 1 supported by a rectal sigmoidoscopy in the preceding 3 months or colonoscopy in the preceding 6 months) for > 1 month prior to entry and had experienced at least one clinical or endoscopic relapse within the previous 12 months were recruited from centers in Italy, Poland and the Ukraine (N = 331) |
| Interventions |
MMX mesalazine 2.4 g/day (n = 162) given once daily or Asacol 2.4 g/day (n = 169) given in two divided doses of 1.2 g for 12 months |
| Outcomes |
The primary outcomes were the proportion of patients in clinical remission and the proportion of patients in clinical and endoscopic remission at 12 months. Secondary outcomes included the time to relapse (UC‐DAI > 1) and assessment of the safety and tolerability of MMX mesalazine 2.4 g/day. Patients were assessed at screening, entry and at 3, 6, 9 and 12 months (or early withdrawal) |
| Notes |
Adherence was checked by tablet counts at each visit. Adherence was defined as taking > 80% of the study medication |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computer generated |
| Allocation concealment (selection bias) |
Low risk |
Centralized randomization |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Double‐blind, double‐dummy |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Drop‐outs balanced across intervention groups with similar reasons for withdrawal |
| Selective reporting (reporting bias) |
Low risk |
All expected outcomes reported |
| Other bias |
Low risk |
The study appears to be free of other sources of bias |
