PMID- 26883035 OWN - NLM STAT- MEDLINE DCOM- 20161213 LR - 20181113 IS - 1179-6901 (Electronic) IS - 1174-5886 (Print) IS - 1174-5886 (Linking) VI - 16 IP - 1 DP - 2016 Mar TI - Investigation of a High-Dose pH-Dependent-Release Mesalazine on the Induction of Remission in Active Crohn's Disease. PG - 35-43 LID - 10.1007/s40268-015-0113-9 [doi] AB - INTRODUCTION: 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. TRIAL REGISTRATION NUMBER: JapicCTI-111460. FAU - Suzuki, Yasuo AU - Suzuki Y AD - Department of Internal Medicine Organization, Toho University Sakura Medical Center, 564-1 Shimoshizu, sakura-shi, Chiba, 285-8741, Japan. FAU - Iida, Mitsuo AU - Iida M AD - Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers, 3-23-1 Shiobaru, Minamiku, Fukuoka, 815-8588, Japan. FAU - Ito, Hiroaki AU - Ito H AD - Kinshukai Infusion Clinic, 3-1 Ofuka cho, Kitaku, Osaka-shi, Osaka, 530-0011, Japan. FAU - Tachikawa, Naoto AU - Tachikawa N AD - Clinical Research 2, ZERIA Pharmaceutical Co., Ltd., 10-11, Nihonbashi Kobuna-Cho, Chuo-Ku, Tokyo, 103-8351, Japan. FAU - Hibi, Toshifumi AU - Hibi T AD - Kitasato Institute Hospital, Kitasato University, 5-9-1 Shirokane, Minato-ku, Tokyo, 108-8642, Japan. thibi@insti.kitasato-u.ac.jp. LA - eng PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't PL - New Zealand TA - Drugs R D JT - Drugs in R&D JID - 100883647 RN - 0 (Anti-Inflammatory Agents, Non-Steroidal) RN - 4Q81I59GXC (Mesalamine) SB - IM MH - Adolescent MH - Adult MH - Anti-Inflammatory Agents, Non-Steroidal/*administration & dosage/adverse effects/*therapeutic use MH - Crohn Disease/*drug therapy MH - Female MH - Humans MH - Hydrogen-Ion Concentration MH - Male MH - Mesalamine/*administration & dosage/adverse effects/*therapeutic use MH - Middle Aged MH - Remission Induction/methods MH - Young Adult PMC - PMC4767719 EDAT- 2016/02/18 06:00 MHDA- 2016/12/15 06:00 PMCR- 2016/02/16 CRDT- 2016/02/18 06:00 PHST- 2016/02/18 06:00 [entrez] PHST- 2016/02/18 06:00 [pubmed] PHST- 2016/12/15 06:00 [medline] PHST- 2016/02/16 00:00 [pmc-release] AID - 10.1007/s40268-015-0113-9 [pii] AID - 113 [pii] AID - 10.1007/s40268-015-0113-9 [doi] PST - ppublish SO - Drugs R D. 2016 Mar;16(1):35-43. doi: 10.1007/s40268-015-0113-9.