Deventer 2006.
Methods | A randomised, placebo‐controlled, double‐blind, two‐dose ranging multi‐center study (N = 112) | |
Participants | Adult patients > 18 years with active distal UC and a left‐sided disease flare (mucosal involvement 5‐50 cm for the anal verge) Disease activity index (DAI) score score between 4‐10 that included an abnormal endoscopic score, and were receiving, alone or in combination, stable doses of oral mesalazine (> 30 days), AZA (> 60 days), or 6‐MP (> 60 days) prior to the study |
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Interventions | Group 1: 120 mg alicaforsen daily for 10 days and then every other day thereafter (n = 22) Group 2: 240 mg alicaforsen every other day (n = 23) Group 3: 240 mg alicaforsen daily for 10 days and then every other day (n = 23) Group 4: 240 mg alicaforsen daily (n = 22) Group 5: placebo (n = 22) |
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Outcomes | Primary outcome: UCDAI at week 6 Secondary outcomes: clinical improvement, relapse rates and durability of response |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not described beyond 'double‐blind' |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
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 were reported |
Other bias | Low risk | The study appears to be free of other sources of bias |