Feagan 2013.
Study characteristics | ||
Methods | Randomized, double‐blind, placebo‐controlled, multicenter, phase 3 study | |
Participants | Adults (18 years or older) with a documented diagnosis of mild‐to‐moderate UC, defined by a modified UC‐DAI (N = 281) | |
Interventions | Asacol 4.8 g/day (n = 140) or placebo (n = 141) | |
Outcomes | Primary outcome: proportion of participants in clinical remission, defined as a score of 0 for stool frequency and rectal bleeding, and absence of fecal urgency at week 6 Secondary outcomes: clinical remission at weeks 6 and 10, endoscopic remission (defined as a sigmoidoscopic score of < 1) at week 6, endoscopic remission at week 10, improvement (defined as a decrease of at least 3 points from baseline in the modified UC‐DAI score) at week 6, improvement at week 10, mean changes in the modified UC‐DAI and UCCS from baseline to week 10, and adverse events |
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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 | Generated in permutated blocks by computer |
Allocation concealment (selection bias) | Low risk | An interactive voice/web response system managed the randomization procedure and dispensed the study drug |
Blinding (performance bias and detection bias) All outcomes | Low risk | Participants and central readers were blinded |
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 of other sources biases |