Long-term Elobixibat for Chronic Constipation (TANK-27)

Yokohama City University

Status and phase: Enrolling; Phase 4

Conditions: Chronic Constipation

Treatments: Drug: Placebo; Drug: Elobixibat 10mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04784780

jRCTs031200363

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No 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).
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

Elobixibat

Experimental group

Description:

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

Treatment:

Drug: Elobixibat 10mg

Placebo

Placebo Comparator group

Description:

AJG533 placebo orally once a day before meals for 12 weeks

Treatment:

Drug: Placebo