Elobixibat for Chronic Constipation Without Defecation Desire (R-LODD)

Yokohama City University

Status and phase

Unknown

Phase 4

Conditions

Chronic Constipation

Treatments

Drug: Elobixibat 10mg

Study type

Interventional

Funder types

Other

Identifiers

NCT05165199

21-008

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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