caa a22 4500 445887656 CHVBK 20180317145604.0 cr unu---uuuuu 170323e20110101xx s 000 0 eng 10.1007/s00535-010-0308-3 doi (NATIONALLICENCE)springer-10.1007/s00535-010-0308-3 Clinical trial: effects of an oral preparation of mesalazine at 4g/day on moderately active ulcerative colitis. A phase III parallel-dosing study [Elektronische Daten] [Nobuo Hiwatashi, Yasuo Suzuki, Keiichi Mitsuyama, Akihiro Munakata, Toshifumi Hibi] Background and aims: Oral mesalazine formulations are effective in the treatment of active ulcerative colitis (UC). It is not clear what induction dose of mesalazine is optimal for treating patients with active UC. We aimed to evaluate the efficacy and safety of 4 versus 2.25g/day for selected patients with active UC. Methods: A multicenter, randomized, double-blind, parallel-group clinical study in 39 Japanese medical institutions. A total of 123 patients with moderately active UC received 4g/day (two divided doses) versus 2.25g/day (three divided doses) for 8weeks. Primary endpoint was the ulcerative colitis-disease activity index (UC-DAI) score before and after 8weeks of treatment. The improvement of each individual UC-DAI variable, remission, and efficacy rates were secondary endpoints. Safety was determined by laboratory data, vital signs, subjective symptoms, and objective findings. Results: Patients receiving 4g/day achieved a change in UC-DAI score significantly superior to those receiving 2.25g/day [−3.0 (95% confidence intervals (CI) −3.8 to −2.3) vs. −0.8 (95% CI −1.8 to 0.1), respectively]. There were significant differences in all UC-DAI variables between the groups. Remission rates were 22.0% (4g/day) and 15.3% (2.25g/day). The efficacy rate was significantly better with 4 versus 2.25g/day [76.3 vs. 45.8%, respectively (95% CI 13.8-47.2); P=0.001]. No difference was seen in adverse events or adverse drug reactions. Conclusions: A dose of 4g/day was significantly superior to 2.25g/day in terms of UC-DAI score for patients with moderately active UC. Safety profiles were similar for both doses. Springer, 2010 Mesalazine nationallicence Ulcerative colitis nationallicence UC-DAI score nationallicence Phase III randomized study nationallicence Hiwatashi Nobuo Department of Gastroenterology, Iwaki Kyoritsu General Hospital, 16 Kusehara, Mimayamachi, Uchigo, 973-8555, Iwaki, Japan aut Suzuki Yasuo Department of Internal Medicine, Toho University Sakura Medical Center, 564-1 Shimoshizu, 285-8741, Sakura, Chiba, Japan aut Mitsuyama Keiichi Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, 67 Asahi-machi, 830-0011, Kurume, Fukuoka, Japan aut Munakata Akihiro First Division of Internal Medicine, Hirosaki University School of Medicine, 5 Zaifucho, 036-8562, Hirosaki, Aomori, Japan aut Hibi Toshifumi Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, 35 Shinano-machi, Shinjuku, 160-8582, Tokyo, Japan aut Journal of Gastroenterology Springer Japan 46/1(2011-01-01), 46-56 0944-1174 46:1<46 2011 46 535 https://doi.org/10.1007/s00535-010-0308-3 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s00535-010-0308-3 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Hiwatashi Nobuo Department of Gastroenterology, Iwaki Kyoritsu General Hospital, 16 Kusehara, Mimayamachi, Uchigo, 973-8555, Iwaki, Japan aut NATIONALLICENCE 700 1- Suzuki Yasuo Department of Internal Medicine, Toho University Sakura Medical Center, 564-1 Shimoshizu, 285-8741, Sakura, Chiba, Japan aut NATIONALLICENCE 700 1- Mitsuyama Keiichi Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, 67 Asahi-machi, 830-0011, Kurume, Fukuoka, Japan aut NATIONALLICENCE 700 1- Munakata Akihiro First Division of Internal Medicine, Hirosaki University School of Medicine, 5 Zaifucho, 036-8562, Hirosaki, Aomori, Japan aut NATIONALLICENCE 700 1- Hibi Toshifumi Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, 35 Shinano-machi, Shinjuku, 160-8582, Tokyo, Japan aut NATIONALLICENCE 773 0- Journal of Gastroenterology Springer Japan 46/1(2011-01-01), 46-56 0944-1174 46:1<46 2011 46 535 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer