Chronic constipation
Conditions
Interventions
None listed
Sponsors
NHO Hakodate Medical Center
Hokkaido Cancer Society
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients 18 years of age or older 2. Patients who were judged by a doctor to be inadequate for treatment with existing therapies alone in terms of efficacy and safety. 3. Patients who received elobixibat according to the dosage and administration during the study period (concomitant use with other laxatives allowed) 4. Patients who underwent rectal ultrasonography on the day before the initial administration of elobixibat
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactMomoko Watanabe
SRD Co., Ltd. Clinical Research Department
Outcome results
None listed