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Clinical trial : once-daily mesalamine granules for maintenance of remission of ulcerative colitis - a 6-month placebo-controlled trial . BACKGROUND Ulcerative colitis ( UC ) is a chronic relapsing and remitting idiopathic inflammatory bowel disorder . AIM To evaluate once-daily mesalamine ( mesalazine ) granules ( MG ) for maintenance of remission of UC . METHODS Randomized , double-blind , placebo-controlled trial of patients ( n=209 MG , n=96 placebo ) with UC in remission [ revised Sutherland Disease Activity Index ( SDAI ) rectal bleeding=0 , mucosal appearance < 2 ] who took MG 1.5 g or placebo once-daily for up to 6 months . Primary efficacy endpoint : the percentage of patients who remained relapse-free at month 6/end of treatment . Relapse was defined as SDAI rectal bleeding score ≥1 and a mucosal appearance score ≥2 , a UC flare , or initiation of medication to treat a UC flare . RESULTS The percentage of relapse-free patients at month 6/end of treatment was higher with MG than placebo ( 78.9 % vs. 58.3 % , P < 0.001 ) in the intent-to-treat analysis . Significant differences ( P ≤ 0.025 ) favouring MG were observed for most secondary endpoints including improvement in rectal bleeding , physician 's disease activity rating , stool frequency , the SDAI at month 6/end of treatment , patients classified as a treatment success and relapse-free duration . The incidence of adverse events was similar between groups . CONCLUSIONS Once-daily mesalamine ( mesalazine ) was effective in maintaining remission of UC for 6 months .
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Intervention_Pharmacological
mesalamine
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Intervention_Pharmacological
mesalamine
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Intervention_Pharmacological
mesalazine
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Intervention_Control
or placebo
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Outcome_Other
revised Sutherland Disease Activity Index ( SDAI )