D'Haens 2017.
Study characteristics | ||
Methods | Randomized, active‐controlled, multicenter, non‐inferiority induction trial | |
Participants | Adults (18 years and older) diagnosed with mild‐to‐moderate ulcerative colitis (N = 817) | |
Interventions | Participants received 3.2 g of oral mesalazine administered as 2 x 1600 mg tablets each morning or 4 x 400 mg tablets taken twice daily for 8 weeks | |
Outcomes | Primary outcome: The proportion of participants in clinical and endoscopic remission at week 8 Secondary outcomes: Endoscopic remission, endoscopic response, clinical remission at week 8, rectal bleeding subscore of 0 at week 8, clinical and endoscopic response at week 8, clinical remission at week 12, clinical response at week 12, rectal bleeding subscore of 0 at week 12, clinical remission at weeks 8 and 10 and 12, clinical response at weeks 8 and 12 |
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Notes | Study was funded by Tillotts Pharma, AG. Author conflicts of interest are reported in the manuscript |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | The randomization schedule was generated by computer in permuted blocks of 6 without stratification |
Allocation concealment (selection bias) | Low risk | An interactive web response system was used to manage randomization and dispense the study drug |
Blinding (performance bias and detection bias) All outcomes | Low risk | All participants took the same numer of identical‐looking 1600 mg or 400 mg placebo tablets. Investigators, central readers and participants were unaware of the participant assignment |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants involved in the trial were accounted for with reasons |
Selective reporting (reporting bias) | Low risk | Expected outcomes were reported in the published study |
Other bias | Low risk | The study appears to be free from other sources of bias |