Elobixibat for Chronic Constipation Without Defecation Desire

• Status: Not yet recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients of chronic constipation without defecation desire will be orally administered elobixibat 10 mg once daily before meals for 4 weeks. The primary endpoint of the pre/post comparative study will be the percentage of improvement in bowel movements from Week 2 of the observation period at Week 4 of the treatment period.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yokohama City University

Criteria

Inclusion Criteria:

At the time of provisional registration

• Patients diagnosed with chronic constipation using the Rome IV criteria for the diagnosis of chronic constipation

• Age: 20 years or older (at the time of obtaining consent)

• Gender: Any

• outpatients

• Patients for whom written consent can be obtained

• Patients who can record defecation, etc. in the patient diary

At the time of registration: Dosing start criteria Patients with the following ・'Loss of defecation desire'* in the second week of the observation period (1 week before the start of the treatment period)

*"Loss of defecation desire " refers to patients whose "presence or absence of defecation desire" on the patient questionnaire was "4. almost never" or "5. never".

Exclusion Criteria:

At the time of temporary registration Exclude patients with any of the following conditions

• Patients with organ-related constipation or suspected of having organ-related constipation

• Patients with or suspected of having functional ileus

• Patients with or suspected of having inguinal hernia

• Patients with a history of open abdominal surgery within 12 weeks prior to obtaining consent (excluding appendicitis resection)

• Patients with a history of surgical or endoscopic procedures related to gallbladder resection and papillotomy

• Patients with complications of malignancy However, patients who have undergone radical surgery or who have completed chemotherapy or radiotherapy may be registered.

• Pregnant women, lactating women, women who may be currently pregnant, or patients who cannot give consent to use contraception while participating in the study

• Patients with serious renal, hepatic, or cardiac disease

• Patients with drug allergy to the study drug

• Patients who are participating in other clinical studies, or who have participated in other clinical studies within 4 weeks prior to obtaining consent However, observational studies are excluded.

• Other patients who are judged by the principal investigator or sub-investigator to be inappropriate for this study.

At the time of registration: Dosing start criteria

• Patients who increased the dose of concomitantly restricted drugs during the observation period

• Patients who used concomitantly prohibited drugs during the observation period