Adrenomedullin for steroid-resistant ulcerative colitis: a randomized, double-blind, placebo-controlled phase-2a clinica
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ORIGINAL ARTICLE—ALIMENTARY TRACT
Adrenomedullin for steroid-resistant ulcerative colitis: a randomized, double-blind, placebo-controlled phase-2a clinical trial Toshihiro Kita1 • Sinya Ashizuka1 • Naoki Ohmiya2 • Takayuki Yamamoto3 • Takanori Kanai4 • Satoshi Motoya5 • Fumihito Hirai6,17 • Hiroshi Nakase7 • Tomohiko Moriyama8 • Masanao Nakamura9 • Yasuo Suzuki10 • Shuji Kanmura11 Taku Kobayashi12 • Hidehisa Ohi13 • Ryoichi Nozaki14 • Keiichi Mitsuyama15 • Shojiro Yamamoto16 • Haruhiko Inatsu1 • Koji Watanabe1 • Toshifumi Hibi12 • Kazuo Kitamura1
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Received: 25 August 2020 / Accepted: 18 October 2020 Ó The Author(s) 2020
Abstract Background Adrenomedullin (AM) is a bioactive peptide having many pleiotropic effects, including mucosal healing and immunomodulation. AM has shown beneficial effects in rodent models and in preliminary study for patients with ulcerative colitis (UC). We performed a clinical trial to
investigate the efficacy and safety of AM in patients with UC. Methods This was a multi-center, double-blind, placebocontrolled phase-2a trial evaluating 28 patients in Japan with steroid-resistant UC. Patients were randomly assigned to four groups and given an infusion of 5, 10, 15 ng/kg/min of AM or placebo for 8 h per day for 14 days. The primary endpoint was the change in Mayo scores at 2 weeks. Main 9
Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Japan
10
Department of Gastroenterology, Department of Internal Medicine, Toho University Sakura Medical Center, Sakura, Japan
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Digestive and Lifestyle Diseases, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan
12
Center for Advanced IBD Research and Treatment, Kitasato University Kitasato Institute Hospital, Tokyo, Japan
13
Department of Gastroenterology, Idzuro Imamura Hospital, Kagoshima, Japan
14
Coloproctology Center Takano Hospital, Kumamoto, Japan
15
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan
Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume, Japan
16
Department of Gastroenterology and Hematology, Faculty of Medicine, University of Miyazaki, Miyazaki, Japan
5
IBD Center, Sapporo Kosei General Hospital, Sapporo, Japan
17
6
Department of Gastroenterology and Medicine, Faculty of Medicine, Fukuoka University, Fukuoka, Japan
Department of Gastroenterology, Fukuoka University Chikushi Hospital, Fukuoka, Japan
7
Department of Gastroenterology and Hepatology, Sapporo Medical University School of Medicine, Sapporo, Japan
8
Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan
Electronic supplementary material The online version of this article (https://doi.org/10.1007/s00535-020-01741-4) contains supplementary material, which is available to authorized users. & Toshihiro Kita [email protected] 1
Division of Circulatory and Body F
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