Efficacy and safety of elobixibat administration after diagnostic rectal ultrasonography in patients with chronic constipation

UMIN ID: UMIN000056635

Registered date:06/01/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic constipation
• Date of first enrollment: 2025/01/15
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: Percentage of responders* with spontaneous bowel movement for 3 days after the initial administration of elobixibat in patients with chronic constipation diagnosed by rectal ultrasonography as "no stool accumulation" * Responders are those who have at least one or more bowel movements during the study period without the use of suppositories for bowel movement (bisacodyl suppositories, etc.)/ enema or disimpaction
• Secondary Outcome: 1. Percentage of responders* with spontaneous bowel movement for 3 days after the initial administration of elobixibat in patients with chronic constipation diagnosed by rectal ultrasonography as "stool accumulation with hard stools" and "stool accumulation without hard stools" 2. Percentage of responders* with spontaneous bowel movement for 3 days after the initial administration of elobixibat, regardless of rectal ultrasonographic classification 3. Percentage of responders* with spontaneous bowel movement on day 1 after the initial administration of elobixibat, categorized by rectal ultrasonographic classifications 4. Percentage of responders* with spontaneous bowel movement on day 1 after the initial administration of elobixibat, regardless of rectal ultrasonographic classification 5. Comparison of BSFS before and after the administration of elobixibat 6. Comparison of CSS before and after the administration of elobixibat 7. Comparison of CSS sub scores before and after the administration of elobixibat 8. Relationship between the transverse diameter of the colon and rectum and rectal ultrasonographic classifications, and relationship between the transverse diameter of the colon and rectum and the efficacy of elobixibat 9. Subgroup analysis by background factors for primary and secondary endpoints 10. Items and incidence rates of adverse events and adverse reactions 11. Discontinuation rate * Responders are those who have at least one or more bowel movements during the study period without the use of suppositories for bowel movement (bisacodyl suppositories, etc.)/ enema or disimpaction

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1. Patients with a history of hypersensitivity to elobixibat at the time of the initial administration of elobixibat 2. Patients with confirmed or suspected bowel obstruction due to tumors, hernias, or other causes at the time of the initial administration of elobixibat 3. Patients with suspected constipation due to organic disease at the time of the initial administration of elobixibat 4. Patients who used bowel cleansing agents, enemas, or underwent intestinal lavage within the 2 days before and up to 3 days after the rectal ultrasonography. 5. Patients who participated in clinical trials or interventional studies during the observation period

Related Information

• Primary Sponsor: NHO Hakodate Medical Center
• Secondary Sponsor: Hokkaido Cancer Society
• Source(s) of Monetary Support: EA Pharma Co., Ltd.,Mochida Pharmaceutical Co., Ltd.