title: Mesalazine Modified-Release Tablet in the Treatment of Ulcerative Colitis in the Remission Phase: A Chinese, Multicenter, Single-Blind, Randomized Controlled Study.
abstract: BACKGROUND
  This study aimed to compare the efficacy and safety of two mesalazine formulations in the treatment of Chinese patients with ulcerative colitis (UC) in the remission phase.
  
  
  METHODS
  In this multicenter, single-blind, randomized controlled study conducted from November 2010 to August 2012, 251 patients with UC from 18 hospitals were enrolled. The patients were randomized to treatment with mesalazine modified-release tablets (MR group, n = 126) or other enteric-coated tablets (EC group, n = 125), at 800 mg three-times daily for 48 weeks. The primary efficacy parameter was the rate of non-emergence of bloody stool. If the lower limit of the 95% confidence interval (CI) of the primary efficacy measure was over -10%, the modified-release tablets were considered non-inferior to the enteric-coated tablets. The secondary efficacy parameters included the period of non-emergence of bloody stool and the period of non-recurrence of UC. The incidences of adverse events and adverse drug reactions were compared between the two groups.
  
  
  RESULTS
  At 48 weeks of maintenance treatment, the rates of non-emergence of bloody stool were 82.99% (95% CI 73.53-92.45%) and 73.30% (95% CI 64.04-82.56%) in the MR and EC groups, respectively, and the difference between the two groups was 9.69% (95% CI -1.15-20.53%). There was no significant difference in the period of non-emergence of bloody stool and the period of non-recurrence of UC between the two groups (P > 0.05). The incidences of adverse events were 48.78% (60/123) and 48.00% (60/125) in the MR and EC groups, respectively (P = 0.902). The incidences of adverse drug reactions were 16.26% (20/123) and 13.60% (17/125) in the MR and EC groups, respectively (P = 0.556).
  
  
  CONCLUSIONS
  Mesalazine modified-release tablets were non-inferior to the enteric-coated tablets and may be considered an effective and safe treatment alternative for the maintenance of remission in Chinese patients with UC.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT01257399.
  
  
  BACKGROUND
  Tillotts Pharma AG.
authors.affiliation: Ruijin Hospital Shanghai Jiaotong University School of Medicine, Shanghai, China. sunjing2@medmail.com.cn.
authors.forename: Jing
authors.initials: J
authors.lastname: Sun
authors.affiliation: Ruijin Hospital Shanghai Jiaotong University School of Medicine, Shanghai, China.
authors.forename: Yaozong
authors.initials: Y
authors.lastname: Yuan
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002681:China; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D003692:Delayed-Action Preparations; D005260:Female; D006801:Humans; D008297:Male; D019804:Mesalamine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D016037:Single-Blind Method; D013608:Tablets, Enteric-Coated
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D003692:Delayed-Action Preparations; D013608:Tablets, Enteric-Coated; D019804:Mesalamine
keywords: China; Gastroenterology; Mesalazine; Randomized controlled trial; Remission phase; Ulcerative colitis