Long-term Elobixibat for Chronic Constipation

NCT04784780 | Unknown Phase 4 DMC

• 1 other identifier: jRCTs031200363
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Constipation

Keywords

Elobixibat; Chronic constipation; 12 week; Complete spontaneous bowel movement

Outcome Measures

Primary Outcomes (1)

• Change in the number of complete spontaneous bowel movements at week 12

  Change in the number of complete spontaneous bowel movements at week 12 of the treatment period from week 2 of the observation period. \*Spontaneous defecation without residual sensation.

  Week 12

Secondary Outcomes (15)

• Change in the number of complete spontaneous bowel movements in each week of the treatment period.

  Each Week 1-11

• Change in the number of spontaneous bowel movements in each week of the treatment.

  Each Week 1-11

• Proportion of responders** in the number of SBMs during each week.

  Each Week 1-11

• Proportion of responders** in the number of CSBMs during each week.

  Each Week 1-11

• The rate of a responder in the number of CSBM during the treatment period.

  Week 12

Other Outcomes (1)

• Incidence of adverse events.

  Each Week 1-11

Study Arms (2)

Elobixibat

EXPERIMENTAL

AJG533 (elobixibat) 10 mg orally once a day before meals for 12 weeks

Drug: Elobixibat 10mg

Placebo

PLACEBO COMPARATOR

AJG533 placebo orally once a day before meals for 12 weeks

Drug: Placebo

Interventions

Elobixibat 10mg DRUG

Patients with chronic constipation are administered Elobixibat 10mg for 12 weeks

Also known as: AJG533 10 mg

Elobixibat

Placebo DRUG

Patients with chronic constipation are administered placebo for 12 weeks

Also known as: AJG533 placebo

Placebo

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Patients with contraindications to rescue drugs (bisacodyl suppositories and prusenide tablets).
• Patients who are participating in another clinical study or who were participating in another clinical study within 4 weeks before consent was obtained, excluding observational studies.
• Patients who are judged by the principal investigator or sub-physician to be inappropriate for conducting this research.

Sponsors & Collaborators

• Yokohama City University: lead

Study Sites (1)

Yokohama City University

Yokohama, Kanagawa, 236-0004, Japan

RECRUITING

Related Publications (2)

• Nakajima A, Seki M, Taniguchi S, Ohta A, Gillberg PG, Mattsson JP, Camilleri M. Safety and efficacy of elobixibat for chronic constipation: results from a randomised, double-blind, placebo-controlled, phase 3 trial and an open-label, single-arm, phase 3 trial. Lancet Gastroenterol Hepatol. 2018 Aug;3(8):537-547. doi: 10.1016/S2468-1253(18)30123-7. Epub 2018 May 25.

  PMID: 29805116 BACKGROUND

• Tanaka K, Kessoku T, Yamamoto A, Takahashi K, Kasai Y, Ozaki A, Iwaki M, Kobayashi T, Yoshihara T, Misawa N, Kato T, Arimoto J, Fuyuki A, Sakai E, Higurashi T, Chiba H, Hosono K, Yoneda M, Iwasaki T, Kurihashi T, Nakatogawa M, Suzuki A, Taguri M, Oyamada S, Ariyoshi K, Kobayashi N, Ichikawa Y, Nakajima A. 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. BMJ Open. 2022 May 30;12(5):e060704. doi: 10.1136/bmjopen-2021-060704.

  PMID: 35636802 DERIVED

MeSH Terms

Interventions

elobixibat

Study Officials

• Takaomi Kessoku, M.D., PhD.

  Yokohama City University

  PRINCIPAL INVESTIGATOR

Central Study 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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 28, 2021
• First Posted: March 5, 2021
• Study Start: August 6, 2021
• Primary Completion: June 30, 2023
• Study Completion: November 30, 2023
• Last Updated: January 5, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)