Sandborn 2009.
Study characteristics | ||
Methods | Multicenter, randomized, double‐blind, double‐dummy, active‐controlled trial (ASCEND III) | |
Participants | Adults (aged 18 to 75 years) with moderately‐active ulcerative colitis that extended proximally beyond 15 cm from the anal verge, as confirmed by flexible sigmoidoscopy or colonoscopy (N = 772) | |
Interventions | Asacol 2.4 g/day (400 mg tablet; n = 383) or 4.8 g/day of mesalamine (Asacol 800 mg tablet; n = 389) for 6 weeks | |
Outcomes | Primary outcome: treatment success (overall improvement) at week 6, defined as improvement in the PGA (based on clinical assessments of rectal bleeding, stool frequency, and sigmoidoscopy), with no worsening in any individual clinical assessment Secondary outcomes: clinical remission at weeks 3 and 6; improvement in stool frequency, rectal bleeding, and PFA assessments at weeks 3 and 6; improvement in the sigmoidoscopy with CFT, PGA, and UC‐DAI assessments at week 6; and treatment success in participants with left‐sided disease at week 6 |
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Notes | This study was supported by Procter & Gamble Pharmaceuticals 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 investigator or designated representative telephoned the Interactive Voice Response System for patient randomization and allocation of study medication once the patient was determined to be eligible for the study |
Allocation concealment (selection bias) | Low risk | Interactive Telephone Voice Response System |
Blinding (performance bias and detection bias) All outcomes | Low risk | Double‐blind, double‐dummy, identical placebos |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Dropouts balanced across intervention groups with similar reasons for withdrawal |
Selective reporting (reporting bias) | Low risk | Expected outcomes were reported |
Other bias | Low risk | The study appears to be free of other sources of bias |