ong-term elobixibat for chronic constipatio

Phase 4

Suspended

• Conditions: Chronic constipation; Chronic constipation, elobixibat, complete spontenoous bowelmovement, 12 week, long term,

• Registration Number: JPRN-jRCTs031200363
• Lead Sponsor: Michihiro Iwaki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Patients who meet all of the following (1)-(6)
At registration
(1) Patients diagnosed with chronic constipation by the Rome IV criteria for chronic constipation
(2) Age: 20 years old or older and up to 85 years old (at the time of obtaining consent)
3) Gender: any gender
4) Outpatients
5) Patients who can obtain written consent
(6) Patients who can record their defecation, etc. in the patient's diary
At the time of allocation (dosing initiation criteria)
Patients who meet all of the following (1)-(3)
(1) Spontaneous bowel movements (SBM)* not more than 6 times during the 2-week observation period before the start of treatment
*Defecation occurring without a laxative/enema or explant.
In this study, defecation within 1 day of laxatives or remedies used on the day before the start of the observation period is not considered as spontaneous defecation.
(2) Patients with no soft or watery stools (Bristol Stool Shape Scale 6 or 7) in spontaneous bowel movements (SBM)* during the 2-week observation period before the start of treatment. *If laxatives were used the day before the start of the observation period, or if relief medication was used, defecation within one day after use is excluded.
(3) Patients who have not used concomitantly prohibited drugs or therapies during the observation period

Exclusion Criteria

Patients with any of the following conditions are excluded
(1) Patients with organic constipation or patients with suspected organic constipation.
(2) Patients with or suspected of having functional ileus.
(3) Patients with or suspected of having an inguinal hernia.
(4) Patients with a history of open surgery within 12 weeks before obtaining consent (excluding appendicitis resection).
(5) Patients with a history of surgical or endoscopic procedures related to cholecystectomy and papillotomy. (6) Patients with complications of malignancy. However, patients who have undergone radical surgery or completed chemotherapy or radiation therapy can be enrolled.
(7) Pregnant women, lactating women, women who may be currently pregnant, or patients who cannot consent to use contraception while participating in the study.
(8) Patients with serious renal, liver, or cardiac disease.
(9) Patients who are allergic to this study drug.
(10) Patients with contraindications to rescue drugs (bisacodyl suppositories and prusenide tablets). However, if any of the remedies do not fall under a contraindication, they can be registered.
(11) 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.
(12) Patients who are judged by the principal investigator or sub-physician to be inappropriate for conducting this research.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the number of complete spontaneous bowel movements* (CSBM) during week 12 of the treatment period from week 2 of the observation period. *Spontaneous defecation without residual sensation.