Contemporary clinical trials communications · 2022
Rationale and design of a multicenter, single-group, open-label trial aiming at investigating the effectiveness of elobixibat for loss of defecation desire in patients with chronic constipation.
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Yamamoto Atsushi, Kessoku Takaomi, Tanaka Kosuke, Takahashi Kota, Kasai Yuki, Ozaki Anna, Iwaki Michihiro, Kobayashi Takashi, Yoshihara Tsutomu, Misawa Noboru, Ohkuma Kanji, Fuyuki Akiko, Higurashi Takuma, Hosono Kunihiro, Yoneda Masato, Iwasaki Tomoyuki, Kurihashi Takeo, Nakatogawa Machiko, Suzuki Ayao, Taguri Masataka, Oyamada Shunsuke, Ariyoshi Keisuke, Kobayashi Noritoshi, Ichikawa Yasushi, Nakajima Atsushi
Аннотация
BACKGROUND: Approximately 60% of patients with chronic constipation (CC) have a significantly higher rate of loss of defecation desire (LODD). Bile acids are expected to have a restorative effect on defecation desire (DD) because they lower the rectal sensory threshold, which is an objective index of DD. Elobixibat (EXB) specifically inhibits the ileal bile acid transporter/apical sodium-dependent bile acid transporter, which is a transporter involved in the reabsorption of bile acids in the terminal ileum. This study aims to investigate the LODD improvement rate in patients with CC after 4 weeks of EXB treatment.
METHODS: A total of 40 adult patients with CC who meet the eligibility criteria will be enrolled. Patients will receive oral EXB (10 mg/day) for 4 weeks. A patient diary will be provided daily at 4 weeks after treatment. The primary endpoint will be the percentage LODD improvement at week 4 of the treatment period from week 2 of the observation period using questionnaires.
ETHICS AND DISSEMINATION: Ethical approval was obtained from the Yokohama City University Certified Institutional Review Board prior to participant enrolment (approval number: CRB21-008). The results of this study will be submitted for publication in international peer-reviewed journals, and key findings will be presented at international scientific conferences. Participants desiring the results of this study will be directly contacted for data dissemination.
TRIAL REGISTRATION: This trial was registered at ClinicalTrials.gov (NCT05165199).
PROTOCOL VERSION: 1.0, September 21, 2021.
METHODS: A total of 40 adult patients with CC who meet the eligibility criteria will be enrolled. Patients will receive oral EXB (10 mg/day) for 4 weeks. A patient diary will be provided daily at 4 weeks after treatment. The primary endpoint will be the percentage LODD improvement at week 4 of the treatment period from week 2 of the observation period using questionnaires.
ETHICS AND DISSEMINATION: Ethical approval was obtained from the Yokohama City University Certified Institutional Review Board prior to participant enrolment (approval number: CRB21-008). The results of this study will be submitted for publication in international peer-reviewed journals, and key findings will be presented at international scientific conferences. Participants desiring the results of this study will be directly contacted for data dissemination.
TRIAL REGISTRATION: This trial was registered at ClinicalTrials.gov (NCT05165199).
PROTOCOL VERSION: 1.0, September 21, 2021.