Efficacy of elobixibat for recovery of loss of defecation desire in patients with chronic constipation. Multicenter, single-group, unblind study.

Phase 4

Suspended

• Conditions: Chronic constipation

• Registration Number: JPRN-jRCTs031210477
• Lead Sponsor: Iwaki Michihiro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-10
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Patients who meet all of the following
At the time of temporary registration
(1) Patients diagnosed with chronic constipation according to the chronic constipation diagnostic criteria Rome IV
(2) Age: 20 years old or older (at the time of consent acquisition)
(3) Gender: No matter
(4) Outpatient
(5) Patients who can obtain written consent
(6) Patients who can record defecation etc. in the patient diary

At the time of official registration: Criteria for starting administration
Patients who meet the following
Patients who have no desire to defecate in the second week of the observation period (one week before the start of the treatment device)
* No desire to defecate means that the presence
or absence of desire to defecate on the patient questionnaire was 4. Almost none, 5. No desire to defecate.

Exclusion Criteria

Patients who meet any of the following conditions are excluded.
At the time of temporary registration
(1) Patients with structural constipation or suspected patients
(2) Patients with functional ileus or suspected patients
(3) Patients with or suspected inguinal hernia
(4) Patients with a history of abdominal surgery within 12 weeks before obtaining consent (excluding appendicitis resection)
(5) Patients with a history of surgical or endoscopic treatment related to gallbladder resection and papilla incision
(6) Patients with malignant tumor However, patients who have undergone radical surgery or who have completed chemotherapy / radiation therapy can be registered.
(7) Pregnant women, lactating women, women who may be pregnant or patients who do not agree to contraception while participating in the study
(8) Patients with serious renal disease, liver disease, and heart disease
(9) Patients with drug allergy to this research drug
(10) Patients participating in other clinical studies or patients participating in other clinical studies within 4 weeks before obtaining consent However, observational studies are excluded.
(11) Other patients who are judged to be inappropriate for conducting this study by the principal investigator or the investigator

At the time of official registration: Criteria for starting administration
(1) Patients whose dose was increased with the concomitant restriction drug during the observation period
(2) Patients who used prohibited drugs during the observation period

Study & Design

• Study Type: Interventional
• Study Design: Not specified