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Elobixibat for Chronic Constipation Without Defecation Desire | Clinical Trials | Clareo Health

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Elobixibat for Chronic Constipation Without Defecation Desire

A Multicenter, Single-group, Open-label, Before-and-after Study Confirming Recovery of Defecation Desire by Administration of Elobixibat in Patients With Chronic Constipation

NCT05165199•Yokohama City University

View on ClinicalTrials.gov

Summary

Patients of chronic constipation without defecation desire will be orally administered elobixibat 10 mg once daily before meals for 4 weeks. The primary endpoint of the pre/post comparative study will be the percentage of improvement in bowel movements from Week 2 of the observation period at Week 4 of the treatment period.

Eligibility

Age

20 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•At the time of provisional registration
•Patients diagnosed with chronic constipation using the Rome IV criteria for the diagnosis of chronic constipation
•Age: 20 years or older (at the time of obtaining consent)
•Gender: Any
•outpatients
•Patients for whom written consent can be obtained
•Patients who can record defecation, etc. in the patient diary
•At the time of registration: Dosing start criteria Patients with the following ・'Loss of defecation desire'\* in the second week of the observation period (1 week before the start of the treatment period)
•\*"Loss of defecation desire " refers to patients whose "presence or absence of defecation desire" on the patient questionnaire was "4. almost never" or "5. never".

Exclusion Criteria

•At the time of temporary registration Exclude patients with any of the following conditions
•Patients with organ-related constipation or suspected of having organ-related constipation
•Patients with or suspected of having functional ileus
•Patients with or suspected of having inguinal hernia
•Patients with a history of open abdominal surgery within 12 weeks prior to obtaining consent (excluding appendicitis resection)
•Patients with a history of surgical or endoscopic procedures related to gallbladder resection and papillotomy
•Patients with complications of malignancy However, patients who have undergone radical surgery or who have completed chemotherapy or radiotherapy may be registered.
•Pregnant women, lactating women, women who may be currently pregnant, or patients who cannot give consent to use contraception while participating in the study
•Patients with serious renal, hepatic, or cardiac disease
•Patients with drug allergy to the study drug
+5 more criteria

Locations (1)

Yokohama City University

Yokohama, Kanagawa, Japan

Key Dates

Start Date

March 1, 2022

Primary Completion Date

September 1, 2022

Completion Date

March 1, 2023

Last Updated

March 23, 2022

Enrollment

ESTIMATED participants

Conditions

Chronic Constipation

Interventions

Elobixibat 10mg

DRUG

Contacts

Takaomi Kessoku, M.D., PhD.

CONTACT

+81-45-787-2800 takaomi0027@gmail.com

Atsushi Nakajima, M.D., PhD.

CONTACT

+81-45-787-2800 nakajima-tky@umin.ac.jp

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 23, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Elobixibat for Chronic Constipation Without Defecation Desire

Inclusion Criteria

Exclusion Criteria

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