Elobixibat for Chronic Constipation Without Defecation Desire

Phase 4

Terminated

• Conditions: Chronic Constipation
• Interventions: Drug: Elobixibat 10mg

• Registration Number: NCT05703464
• Lead Sponsor: International University of Health and Welfare

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-19
• Study First Submitted QC: 2023-01-19
• Study First Posted: 2023-01-30
• Study Start: 2023-02-09
• Status Verified: 2023-03
• Primary Completion: 2023-03-03
• Study Completion: 2023-03-03
• Last Update Submitted: 2023-03-07
• Last Update Posted: 2023-03-09

Recruitment & Eligibility

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

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".

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Elobixibat	Elobixibat 10mg	10mg Elobixibat administration for 4 weeks

Primary Outcome Measures

Name	Time	Method
Percentage of change in loss of defecation desire	Week 4	Percentage of change in loss of defecation desire in the fourth week of the treatment period from the second week of the observation period (patient questionnaire). The presence or absence of defecation desire was assessed using a 5-point scale on the patient questionnaire: 1. always, 2. almost always, 3. a little, 4. almost never, 5. never.

Secondary Outcome Measures

Name	Time	Method
Satisfaction with defecation desire	Week 4	Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire).
Presence of defecation desire	Week 4	Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire). The presence or absence of defecation desire was assessed using a 5-point scale on the patient questionnaire: 1. always, 2. almost always, 3. a little, 4. almost never, 5. never.
Satisfaction of straining	Week 4	Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period(patient questionnaire).
Presence of a sense of incomplete evacuation	Week 4	Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire).
Complete Spontaneous Bowel Movement (CSBM) frequency	Week 4	Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient daily).
Satisfaction with treatment	Week 4	Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire).
Degree of straining	Week 4	Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period(patient questionnaire).
Spontaneous bowel movement (SBM) frequency	Week 4	Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient daily).
Stool hardness based on the Bristol Stool Form Scale	Week 4	Changes in the item in each week of the treatment period and comparison of Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire).
Constipation severity score	Week 4	Comparison of the Constipation severity score at Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire).
Japanese version of the Patient Assessment of Constipation Quality of Life	Week 4	Comparison of the Japanese version of the Patient Assessment of Constipation Quality of Life questionraire at Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire).
Change in defecation time.	Week 4	Changes in the time from taking elobixibat to defecation each week during the treatment period
Change of bile acid concentration	Week 4	Comparison of the bile acid concentration at Week 4 of the treatment period with Week 2 of the observation period (serum and feces).

Trial Locations

Locations (1)

International university health and welfare Narita hospital; 🇯🇵 Narita, Japan