Long-term elobixibat for chronic constipation

JRCT ID: jRCTs031200363

Registered date:15/02/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Chronic constipation
• Date of first enrollment: 29/10/2021
• Target sample size: 100
• Study type: Interventional
• Intervention(s): AJG533 (elobixibat) 10 mg or AJG533 placebo taken orally once a day for 12 weeks before meals

Outcome(s)

• Primary Outcome: Change in the number of complete spontaneous bowel movements* (CSBM) during week 12 of the treatment period from week 2 of the observation period. *Spontaneous defecation without residual sensation.

Secondary Outcome

(1)Change in the number of complete spontaneous bowel movements (CSBM) in each week of the
treatment period, weeks 1 to 11, from week 2 of the observation period.
(2)Change in the number of spontaneous bowel movements (SBM) in each week of the treatment period
from week 2 of the observation period.
(3)Proportion of responders** in the number of spontaneous and complete spontaneous bowel movements (CSBM) during each week of the treatment period. **In this study, we will investigate the effect of the
treatment on the number of spontaneous and complete spontaneous bowel movements of a subject who
has at least one more spontaneous and complete spontaneous bowel movement per week than in the
second week of the observation period, and at least three times per week.
(4)The rate of a responder in the number of CSBM during the treatment period (12 weeks).
Definition of Responder: Patients with 3 or more CSBM per week and 1 or more CSBM per week from
baseline for 9 weeks out of the entire treatment period (12 weeks), including at least 3 weeks in the
treatment period weeks 9 to 12.
(5)Percent change in fecal hardness from week 2 of the observation period based on the Bristol Stool
Quality Scale at each week of the treatment period.
(6)The percentage of change from week 2 of the observation period in the presence or absence of
residual sensation at each week of the treatment period.
(7)Percent change from week 2 of the observation period in the degree of twitching at each week of the
treatment period.
(8)The percentage of change in the presence or absence of bowel movements at each week of the
treatment period from week 2 of the observation period.
(9)Change in JPAQ-QOL score at 4 and 12 weeks of the treatment period from the baseline (V2) of the
study drug.
(10) At 4 weeks and 12 weeks of the treatment period, the changes from before the start of the study drug (V2) are examined.
1 Changes in absolute values and occupancy rate of intestinal microbiota in feces.
2 Changes in absolute values and occupancy rates in blood and fecal bile acids.
3 Changes in absolute values and occupancy rates for organic acids in feces.
4 Changes in absolute values and occupancy rates of amino acids in blood and feces.
5 Amount of change in blood C4.
Safety
Incidence rates of adverse events.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

Patients who meet all of the following (1)-(6)
At registration
(1) Patients diagnosed with chronic constipation by the "Rome IV" criteria for chronic constipation
(2) Age: 20 years old or older and up to 85 years old (at the time of obtaining consent)
3) Gender: any gender
4) Outpatients
5) Patients who can obtain written consent
(6) Patients who can record their defecation, etc. in the patient's diary
At the time of allocation (dosing initiation criteria)
Patients who meet all of the following (1)-(3)
(1) Spontaneous bowel movements (SBM)* not more than 6 times during the 2-week observation period before the start of treatment
*Defecation occurring without a laxative/enema or explant.
In this study, defecation within 1 day of laxatives or remedies used on the day before the start of the observation period is not considered as spontaneous defecation.
(2) Patients with no soft or watery stools (Bristol Stool Shape Scale 6 or 7) in spontaneous bowel movements (SBM)* during the 2-week observation period before the start of treatment. *If laxatives were used the day before the start of the observation period, or if relief medication was used, defecation within one day after use is excluded.
(3) Patients who have not used concomitantly prohibited drugs or therapies during the observation period

Exclude criteria

Patients with any of the following conditions are excluded
(1) Patients with organic constipation or patients with suspected organic constipation.
(2) Patients with or suspected of having functional ileus.
(3) Patients with or suspected of having an inguinal hernia.
(4) Patients with a history of open surgery within 12 weeks before obtaining consent (excluding appendicitis resection).
(5) Patients with a history of surgical or endoscopic procedures related to cholecystectomy and papillotomy. (6) Patients with complications of malignancy. However, patients who have undergone radical surgery or completed chemotherapy or radiation therapy can be enrolled.
(7) Pregnant women, lactating women, women who may be currently pregnant, or patients who cannot consent to use contraception while participating in the study.
(8) Patients with serious renal, liver, or cardiac disease.
(9) Patients who are allergic to this study drug.
(10) Patients with contraindications to rescue drugs (bisacodyl suppositories and prusenide tablets). However, if any of the remedies do not fall under a contraindication, they can be registered.
(11) Patients who are participating in another clinical study or who were participating in another clinical study within 4 weeks before consent was obtained, excluding observational studies.
(12) Patients who are judged by the principal investigator or sub-physician to be inappropriate for conducting this research.

Related Information

• Primary Sponsor: Michihiro Iwaki
• Secondary Sponsor: Kessoku Takaomi
• Source(s) of Monetary Support: EA Pharma Co.,Ltd., MOCHIDA PHARMACEUTICAL CO.,LTD.