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

JRCT ID: jRCTs031210477

Registered date:10/12/2021

Basic Information

• Recruitment status: Suspended
• Health condition(s) or Problem(s) studied: Chronic constipation
• Date of first enrollment: 18/03/2022
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Elobixibat 10 mg orally once daily for 4 weeks before meals

Outcome(s)

• Primary Outcome: Rate of improvement in defecation desire from the 2nd week of the observation period in the 4th week of the treatment period (patient questionnaire)

Secondary Outcome

We will examine the evaluation of the following items and their relevance.
(1) Comparison of changes in the following items in each week of the treatment period and the second week of the observation period in the fourth week of the treatment period
1. Presence or absence of defecation desire: Patient questionnaire
2. Satisfaction with defecation desire: Patient questionnaire
3. Satisfaction of straining: Patient Questionnaire
4. Degree of straining: Patient diary
5. Presence or absence of sensation of incomplete evacuation: Patient diary
6. Treatment satisfaction: Patient questionnaire
7. Number of spontaneous bowel movement (SBM)
8. Number of complete spontaneous bowel movement (CSBM)
9. Stool hardness based on Bristol stool form scale
(2) Comparison of the following items in the 4th week of the treatment period with the 2nd week of the observation period
1. Constipation score: CSS
2. JPAC-QOL score
3. Absolute value and occupancy rate of bile acid concentration in feces
(3) Treatment period Changes in time from taking elobixibat to defecation each week
(4) Examining the relevance between evaluation items

safety
Incidence rate of diseases, etc.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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".

Exclude 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

Related Information

• Primary Sponsor: Iwaki Michihiro
• Secondary Sponsor: Kessoku Takaomi

Source(s) of Monetary Support

MOCHIDA PHARMACEUTICAL CO.,LTD.
EA Pharma Co.,Ltd.