OBJECTIVE: Low-grade intestinal @entity32 plays a role in the pathophysiology of @entity5377 . In this trial, we aimed at evaluating the efficacy and safety of @entity2983 in @entity1 with @entity5377 . DESIGN: We conducted a phase 3, multicentre, tertiary setting, randomised, double-blind, placebo-controlled trial in @entity1 with Rome III confirmed @entity5377 . @entity1 were randomly assigned to either @entity2983 , 800   mg, or placebo, three times daily for 12   weeks, and were followed for additional 12   weeks. The primary efficacy endpoint was satisfactory relief of @entity490 /discomfort for at least half of the weeks of the treatment period. The key secondary endpoint was satisfactory relief of @entity1109 . Supportive analyses were also performed classifying as responders @entity1 with a percentage of affirmative answers of at least 75% or >75% of time. RESULTS: A total of 185 @entity1 with @entity5377 were enrolled from 21 centres. For the primary endpoint, the responder @entity1 were 68.6% in the @entity2983 group versus 67.4% in the placebo group (p=0.870; 95% CI -12.8 to 15.1). In explorative analyses, with the 75% rule or >75% rule, the percentage of responders was greater in the @entity2983 group with a difference over placebo of 11.6% (p=0.115; 95% CI -2.7% to 26.0%) and 5.9% (p=0.404; 95% CI -7.8% to 19.4%), respectively, although these differences were not significant. For the key secondary endpoint, overall symptoms improved in the @entity2983 group and reached a significant difference of 15.1% versus placebo (p=0.032; 95% CI 1.5% to 28.7%) with the >75% rule. CONCLUSIONS: @entity2983 treatment was not superior than placebo on the study primary endpoint. However, a subgroup of @entity1 with @entity5377 showed a sustained therapy response and benefits from a @entity2983 therapy. TRIAL REGISTRATION NUMBER: ClincialTrials.gov number, NCT00626288.

Randomised controlled trial of XXXX in @entity5377 .

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients'] @entity32 :: ('MESH:D007249', 'Disease') :: ['inflammation'] @entity5377 :: ('MESH:D053560', 'Disease') :: ['IBS'] @entity1109 :: ('MESH:D012678', 'Disease') :: ['overall IBS symptoms'] @entity490 :: ('MESH:D015746', 'Disease') :: ['abdominal pain'] @entity2983 :: ('MESH:D019804', 'Chemical') :: ['mesalazine', 'Mesalazine']
@entity2983 :: (MESH:D019804,Chemical) :: ['mesalazine']
