Elobixibat for Chronic Constipation Without Defecation Desire

Chronic Constipation Clinical Trial

— R-LODD  

Official title:

A Multicenter, Single-group, Open-label, Before-and-after Study Confirming Recovery of Defecation Desire by Administration of Elobixibat in Patients With Chronic Constipation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05165199
• Other study ID #: 21-008
• Status: Recruiting
• Phase: Phase 4
• Start date: March 1, 2022
• Est. completion date: March 2023

Study information

• Verified date: March 2022
• Source: Yokohama City University
• Contact: Takaomi Kessoku, M.D., PhD.
• Phone: +81-45-787-2800
• Email: takaomi0027[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2023
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Constipation
• Constipation

Intervention

Drug:
• Elobixibat 10mg
Patients of chronic constipation with loss of defecation desire are administered Elobixibat 10mg for 4 weeks

Locations

Country	Name	City	State
Japan	Yokohama City University	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Yokohama City University

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Ohkubo H, Takatsu T, Yoshihara T, Misawa N, Ashikari K, Fuyuki A, Matsuura T, Higurashi T, Yamamoto K, Matsumoto H, Odaka T, Lembo AJ, Nakajima A. Difference in Defecation Desire Between Patients With and Without Chronic Constipation: A Large-Scale Internet Survey. Clin Transl Gastroenterol. 2020 Sep;11(9):e00230. doi: 10.14309/ctg.0000000000000230. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence rate of diseases	Safety assessment	Week 0-4
Primary	Percentage of change in loss of defecation desire	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.	Week 4
Secondary	Presence of defecation desire	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.	Week 4
Secondary	Satisfaction with defecation desire	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).	Week 4
Secondary	Satisfaction of straining	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).	Week 4
Secondary	Degree of straining	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).	Week 4
Secondary	Presence of a sense of incomplete evacuation	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).	Week 4
Secondary	Satisfaction with treatment	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).	Week 4
Secondary	Spontaneous bowel movement (SBM) frequency	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).	Week 4
Secondary	Complete Spontaneous Bowel Movement (CSBM) frequency	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).	Week 4
Secondary	Stool hardness based on the Bristol Stool Form Scale	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).	Week 4
Secondary	Constipation severity score	Comparison of the Constipation severity score at Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire).	Week 4
Secondary	Japanese version of the Patient Assessment of Constipation Quality of Life	Comparison of the Japanese version of the Patient Assessment of Constipation Quality of Life questionrair at Week 4 of the treatment period with Week 2 of the observation period (patient questionnaire).	Week 4
Secondary	Change of bile acid cocentration	Comparison of the bile acid concentration at Week 4 of the treatment period with Week 2 of the observation period (serum and feces).	Week 4
Secondary	Change in defecation time.	Changes in the time from taking elobixibat to defecation each week during the treatment period	Week 4