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Rationale and design of a multicentre, 12-week, randomised, double-blind, placebo-controlled, parallel-group, investigator-initiated trial to investigate the efficacy and safety of elobixibat for chronic constipation
INTRODUCTION: Chronic constipation (CC) is a functional disorder that negatively impacts the quality of life of patients. This is a protocol for a multicentre, 12-week, randomised, double-blind, placebo-controlled study to test the efficacy and safety of elobixibat (EXB) versus placebo in patients w...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BMJ Publishing Group
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9152941/ https://www.ncbi.nlm.nih.gov/pubmed/35636802 http://dx.doi.org/10.1136/bmjopen-2021-060704 |
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author | Tanaka, Kosuke Kessoku, Takaomi Yamamoto, Atsushi Takahashi, Kota Kasai, Yuki Ozaki, Anna Iwaki, Michihiro Kobayashi, Takashi Yoshihara, Tsutomu Misawa, Noboru Kato, Takayuki Arimoto, Jun Fuyuki, Akiko Sakai, Eiji Higurashi, Takuma Chiba, Hideyuki Hosono, Kunihiro Yoneda, Masato Iwasaki, Tomoyuki Kurihashi, Takeo Nakatogawa, Machiko Suzuki, Ayao Taguri, Masataka Oyamada, Shunsuke Ariyoshi, Keisuke Kobayashi, Noritoshi Ichikawa, Yasushi Nakajima, Atsushi |
author_facet | Tanaka, Kosuke Kessoku, Takaomi Yamamoto, Atsushi Takahashi, Kota Kasai, Yuki Ozaki, Anna Iwaki, Michihiro Kobayashi, Takashi Yoshihara, Tsutomu Misawa, Noboru Kato, Takayuki Arimoto, Jun Fuyuki, Akiko Sakai, Eiji Higurashi, Takuma Chiba, Hideyuki Hosono, Kunihiro Yoneda, Masato Iwasaki, Tomoyuki Kurihashi, Takeo Nakatogawa, Machiko Suzuki, Ayao Taguri, Masataka Oyamada, Shunsuke Ariyoshi, Keisuke Kobayashi, Noritoshi Ichikawa, Yasushi Nakajima, Atsushi |
author_sort | Tanaka, Kosuke |
collection | PubMed |
description | INTRODUCTION: Chronic constipation (CC) is a functional disorder that negatively impacts the quality of life of patients. This is a protocol for a multicentre, 12-week, randomised, double-blind, placebo-controlled study to test the efficacy and safety of elobixibat (EXB) versus placebo in patients with CC. METHODS AND ANALYSIS: This will be a multicentre, double-blind, placebo-control, randomised controlled trial. A total of 100 adult patients with CC, diagnosed based on Rome IV criteria, who fulfil the inclusion/exclusion criteria will be enrolled. The patients will be randomly assigned to receive EXB (10 mg) or placebo treatment (n=50 per group). Blood tests and stool sampling will be performed 12 weeks following initiation of treatment and questionnaires will be issued to participants. The primary outcome will be the change in complete spontaneous bowel movements after 12 weeks of administration. The secondary outcomes will include the change in Japanese Patient Assessment of Constipation Quality of Life and absolute serum and faecal bile acid. ETHICS AND DISSEMINATION: Ethics approval has been obtained from Yokohama City University Certified Institutional Review Board before participant enrolment. The results of this study will be submitted for publication in international peer-reviewed journals and the key findings will be presented at international scientific conferences. PROTOCOL VERSION: V.3.0, 15 June 2021. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov (number NCT04784780). |
format | Online Article Text |
id | pubmed-9152941 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-91529412022-06-16 Rationale and design of a multicentre, 12-week, randomised, double-blind, placebo-controlled, parallel-group, investigator-initiated trial to investigate the efficacy and safety of elobixibat for chronic constipation Tanaka, Kosuke Kessoku, Takaomi Yamamoto, Atsushi Takahashi, Kota Kasai, Yuki Ozaki, Anna Iwaki, Michihiro Kobayashi, Takashi Yoshihara, Tsutomu Misawa, Noboru Kato, Takayuki Arimoto, Jun Fuyuki, Akiko Sakai, Eiji Higurashi, Takuma Chiba, Hideyuki Hosono, Kunihiro Yoneda, Masato Iwasaki, Tomoyuki Kurihashi, Takeo Nakatogawa, Machiko Suzuki, Ayao Taguri, Masataka Oyamada, Shunsuke Ariyoshi, Keisuke Kobayashi, Noritoshi Ichikawa, Yasushi Nakajima, Atsushi BMJ Open Gastroenterology and Hepatology INTRODUCTION: Chronic constipation (CC) is a functional disorder that negatively impacts the quality of life of patients. This is a protocol for a multicentre, 12-week, randomised, double-blind, placebo-controlled study to test the efficacy and safety of elobixibat (EXB) versus placebo in patients with CC. METHODS AND ANALYSIS: This will be a multicentre, double-blind, placebo-control, randomised controlled trial. A total of 100 adult patients with CC, diagnosed based on Rome IV criteria, who fulfil the inclusion/exclusion criteria will be enrolled. The patients will be randomly assigned to receive EXB (10 mg) or placebo treatment (n=50 per group). Blood tests and stool sampling will be performed 12 weeks following initiation of treatment and questionnaires will be issued to participants. The primary outcome will be the change in complete spontaneous bowel movements after 12 weeks of administration. The secondary outcomes will include the change in Japanese Patient Assessment of Constipation Quality of Life and absolute serum and faecal bile acid. ETHICS AND DISSEMINATION: Ethics approval has been obtained from Yokohama City University Certified Institutional Review Board before participant enrolment. The results of this study will be submitted for publication in international peer-reviewed journals and the key findings will be presented at international scientific conferences. PROTOCOL VERSION: V.3.0, 15 June 2021. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov (number NCT04784780). BMJ Publishing Group 2022-05-30 /pmc/articles/PMC9152941/ /pubmed/35636802 http://dx.doi.org/10.1136/bmjopen-2021-060704 Text en © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Gastroenterology and Hepatology Tanaka, Kosuke Kessoku, Takaomi Yamamoto, Atsushi Takahashi, Kota Kasai, Yuki Ozaki, Anna Iwaki, Michihiro Kobayashi, Takashi Yoshihara, Tsutomu Misawa, Noboru Kato, Takayuki Arimoto, Jun Fuyuki, Akiko Sakai, Eiji Higurashi, Takuma Chiba, Hideyuki Hosono, Kunihiro Yoneda, Masato Iwasaki, Tomoyuki Kurihashi, Takeo Nakatogawa, Machiko Suzuki, Ayao Taguri, Masataka Oyamada, Shunsuke Ariyoshi, Keisuke Kobayashi, Noritoshi Ichikawa, Yasushi Nakajima, Atsushi Rationale and design of a multicentre, 12-week, randomised, double-blind, placebo-controlled, parallel-group, investigator-initiated trial to investigate the efficacy and safety of elobixibat for chronic constipation |
title | Rationale and design of a multicentre, 12-week, randomised, double-blind, placebo-controlled, parallel-group, investigator-initiated trial to investigate the efficacy and safety of elobixibat for chronic constipation |
title_full | Rationale and design of a multicentre, 12-week, randomised, double-blind, placebo-controlled, parallel-group, investigator-initiated trial to investigate the efficacy and safety of elobixibat for chronic constipation |
title_fullStr | Rationale and design of a multicentre, 12-week, randomised, double-blind, placebo-controlled, parallel-group, investigator-initiated trial to investigate the efficacy and safety of elobixibat for chronic constipation |
title_full_unstemmed | Rationale and design of a multicentre, 12-week, randomised, double-blind, placebo-controlled, parallel-group, investigator-initiated trial to investigate the efficacy and safety of elobixibat for chronic constipation |
title_short | Rationale and design of a multicentre, 12-week, randomised, double-blind, placebo-controlled, parallel-group, investigator-initiated trial to investigate the efficacy and safety of elobixibat for chronic constipation |
title_sort | rationale and design of a multicentre, 12-week, randomised, double-blind, placebo-controlled, parallel-group, investigator-initiated trial to investigate the efficacy and safety of elobixibat for chronic constipation |
topic | Gastroenterology and Hepatology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9152941/ https://www.ncbi.nlm.nih.gov/pubmed/35636802 http://dx.doi.org/10.1136/bmjopen-2021-060704 |
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