Long-term Elobixibat for Chronic Constipation

Last updated: January 3, 2023
Sponsor: Yokohama City University
Overall Status: Active - Recruiting

Phase

4

Condition

Constipation

Treatment

N/A

Clinical Study ID

NCT04784780
jRCTs031200363
  • Ages 20-85
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Patients diagnosed with chronic constipation by the "Rome IV" criteria for chronicconstipation
  • 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 observationperiod before the start of treatment
  • Patients with no soft or watery stools (Bristol Stool Shape Scale 6 or 7) inspontaneous bowel movements during the 2-week observation period before the start oftreatment.
  • Patients who have not used concomitantly prohibited drugs or therapies during theobservation period.

Exclusion

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 tocholecystectomy and papillotomy.
  • Patients with complications of malignancy.
  • Pregnant women, lactating women, women who may be currently pregnant, or patients whocannot 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).
  • Patients with contraindications to rescue drugs (bisacodyl suppositories and prusenidetablets).
  • Patients who are participating in another clinical study or who were participating inanother clinical study within 4 weeks before consent was obtained, excludingobservational studies.
  • Patients who are judged by the principal investigator or sub-physician to beinappropriate for conducting this research.

Study Design

Total Participants: 100
Study Start date:
August 06, 2021
Estimated Completion Date:
November 30, 2023

Connect with a study center

  • Yokohama City University

    Yokohama, Kanagawa 236-0004
    Japan

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.