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Long-term Elobixibat for Chronic Constipation | Clinical Trials | Clareo Health

UNKNOWNPHASE4

Long-term Elobixibat for Chronic Constipation

Long-term Efficacy and Safety of Elobixibat for Chronic Constipation: a Multicenter, Randomised, Double-blind, Placebo-controlled Trial.

NCT04784780•Yokohama City University

View on ClinicalTrials.gov

Summary

In this double-blind comparative study, AJG533 (elobixibat) 10 mg or AJG533 placebo was orally administered once daily before meals for 12 weeks in patients with chronic constipation, and the primary endpoint was the change from Week 2 of the observation period in the number of complete spontaneous bowel movements (CSBM) at Week 12 of the treatment period. The primary endpoint was the change in the number of complete spontaneous bowel movements (CSBM) from Week 2 of the observation period.

Eligibility

Age

20 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients diagnosed with chronic constipation by the "Rome IV" criteria for chronic constipation
•Age: 20 years old or older and up to 85 years old (at the time of obtaining consent)
•Gender: any gender
•outpatients
•Patients who can obtain written consent
•Patients who can record their defecation, etc. in the patient's diary
•At the time of allocation (dosing initiation criteria)
•Spontaneous bowel movements (SBM)\* not more than 6 times during the 2-week observation period before the start of treatment
•Patients with no soft or watery stools (Bristol Stool Shape Scale 6 or 7) in spontaneous bowel movements during the 2-week observation period before the start of treatment.
•Patients who have not used concomitantly prohibited drugs or therapies during the observation period.

Exclusion Criteria

•Patients with organic constipation or patients with suspected organic constipation.
•Patients with or suspected of having functional ileus.
•Patients with or suspected of having an inguinal hernia.
•Patients with a history of open surgery within 12 weeks before obtaining consent (excluding appendicitis resection).
•Patients with a history of surgical or endoscopic procedures related to cholecystectomy and papillotomy.
•Patients with complications of malignancy.
•Pregnant women, lactating women, women who may be currently pregnant, or patients who cannot consent to use contraception while participating in the study.
•Patients with serious renal, liver, or cardiac disease.
•Patients who are allergic to this study drug.
•Patients who have previously taken Goufis tablets (elobixibat).
+3 more criteria

Locations (1)

Yokohama City University

Yokohama, Kanagawa, Japan

Key Dates

Start Date

August 6, 2021

Primary Completion Date

June 30, 2023

Completion Date

November 30, 2023

Last Updated

January 5, 2023

Enrollment

100

ESTIMATED participants

Conditions

Chronic Constipation

Interventions

Elobixibat 10mg

DRUG

Placebo

DRUG

Contacts

Takaomi Kessoku, M.D., PhD.

CONTACT

+81-45-787-2800 kessoku-tho@umin.ac.jp

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: January 5, 2023Data 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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Long-term Elobixibat for Chronic Constipation

Inclusion Criteria

Exclusion Criteria

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