Long-term Elobixibat for Chronic Constipation

NCT ID: NCT04784780

Last Updated: 2023-01-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-06
• Study Completion Date: 2023-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Elobixibat

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

Group Type: EXPERIMENTAL

Elobixibat 10mg

Intervention Type: DRUG

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

Placebo

AJG533 placebo orally once a day before meals for 12 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Patients with chronic constipation are administered placebo for 12 weeks

Interventions

Elobixibat 10mg

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

Intervention Type: DRUG

Placebo

Patients with chronic constipation are administered placebo for 12 weeks

Intervention Type: DRUG

Other Intervention Names

AJG533 10 mg; AJG533 placebo

Eligibility Criteria

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).
• 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yokohama City University

OTHER

Sponsor Role: lead

Responsible Party

Takaomi Kessoku

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Takaomi Kessoku, M.D., PhD.

Role: PRINCIPAL_INVESTIGATOR

Yokohama City University

Locations

Yokohama City University

Yokohama, Kanagawa, Japan

Site Status: RECRUITING

Countries

Japan

Central Contacts

Takaomi Kessoku, M.D., PhD.

Role: CONTACT

kessoku-tho@umin.ac.jp

+81-45-787-2800 ext. 2640

Atsushi Nakajima, M.D., PhD.

Role: CONTACT

nakajima-tky@umin.ac.jp

+81-45-787-2800 ext. 2640

Facility Contacts

Takaomi Kessoku, MD., PhD.

Role: primary

kessoku-tho@umin.ac.jp

+81-45-787-2800 ext. 2640

References

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.

Reference Type: BACKGROUND

PMID: 29805116 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35636802 (View on PubMed)

Other Identifiers

jRCTs031200363

Identifier Type: -

Identifier Source: org_study_id