title: Investigation of a High-Dose pH-Dependent-Release Mesalazine on the Induction of Remission in Active Crohn's Disease.
abstract: BACKGROUND
  The effect of mesalazine in treating active Crohn's disease (CD) remains controversial, possibly due to the various formulae of mesalazine used to treat inflammation located in different regions of the digestive tract.
  
  
  METHODS
  This exploratory, multicenter, uncontrolled, open-label study included 17 patients with active CD. The inclusion criteria were patients with a CD activity index (CDAI) of ≥ 200 and <350, and in whom mucosal lesions were observed in the area from the terminal ileum to the rectum using colonoscopy (CS). Each patient was treated with pH-dependent-release mesalazine at 4.8 g/day. The drug was administered three times daily for 12 weeks. Efficacy was evaluated by the change in CDAI at the time of final observation (at week 12 or at discontinuation), and safety was evaluated by the incidence of adverse events (AEs) and adverse drug reactions (ADRs).
  
  
  RESULTS
  In the full analysis set (n = 17), the change in CDAI at the time of final observation was -67.4, and the mean change in CDAI from baseline was -49.3 at week 2, -61.8 at week 4, -78.3 at week 8, and -101.1 at week 12. A statistically significant improvement was observed from week 2 to week 12 compared with baseline, and the incidences of AEs and ADRs were 94.1 and 58.8%, respectively. All events were known events, as the results suggested, which is in line with the known safety profile of pH-dependent-release mesalazine.
  
  
  CONCLUSIONS
  The results suggest that the administration of pH-dependent-release mesalazine 4.8 g/day for 12 weeks could be an effective and highly safe treatment option for patients with mild to moderately active CD in whom mucosal lesions were observed in the area from the terminal ileum to the rectum.
  
  
  BACKGROUND
  JapicCTI-111460.
authors.affiliation: Department of Internal Medicine Organization, Toho University Sakura Medical Center, 564-1 Shimoshizu, sakura-shi, Chiba, 285-8741, Japan.
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Suzuki
authors.affiliation: Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers, 3-23-1 Shiobaru, Minamiku, Fukuoka, 815-8588, Japan.
authors.forename: Mitsuo
authors.initials: M
authors.lastname: Iida
authors.affiliation: Kinshukai Infusion Clinic, 3-1 Ofuka cho, Kitaku, Osaka-shi, Osaka, 530-0011, Japan.
authors.forename: Hiroaki
authors.initials: H
authors.lastname: Ito
authors.affiliation: Clinical Research 2, ZERIA Pharmaceutical Co., Ltd., 10-11, Nihonbashi Kobuna-Cho, Chuo-Ku, Tokyo, 103-8351, Japan.
authors.forename: Naoto
authors.initials: N
authors.lastname: Tachikawa
authors.affiliation: Kitasato Institute Hospital, Kitasato University, 5-9-1 Shirokane, Minato-ku, Tokyo, 108-8642, Japan. thibi@insti.kitasato-u.ac.jp.
authors.forename: Toshifumi
authors.initials: T
authors.lastname: Hibi
mesh_terms: D000293:Adolescent; D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D003424:Crohn Disease / Q000188:drug therapy*; D005260:Female; D006801:Humans; D006863:Hydrogen-Ion Concentration; D008297:Male; D019804:Mesalamine / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D012074:Remission Induction / Q000379:methods; D055815:Young Adult
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D019804:Mesalamine