Tokyo, Sept. 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062789) titled 'A retrospective observational study on the efficacy and safety of elobixibat in patients with schizophrenia and chronic constipation.' on Sept. 2.

Study Type: Observational

Primary Sponsor: Institute - Fujita Kokoro Care Center, Okehazama Hospital

Condition: Condition - Schizophrenia and Chronic Constipation Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to investigate the efficacy and safety of elobixibat in patients with schizophrenia who have chronic constipation. In addition, the relationship between bowel movement frequency and psychiatric symptoms will be explored in an exploratory manner. Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Male or female patients aged 18 years or older Patients diagnosed with chronic constipation Patients diagnosed with schizophrenia Patients who were hospitalized at this institution from 1 week prior to the initiation of elobixibat to 2 weeks after the start of treatment Patients who received elobixibat for at least 2 weeks and had available bowel movement frequency data Patients who were first administered elobixibat in accordance with the approved dosage and administration between April 19, 2018, and June 16, 2026 Key exclusion criteria - Patients who were prescribed any constipation medication during the observation period* in a manner that deviated from the approved dosage and administration Patients with a history of hypersensitivity to at the initiation of treatment Patients in whom intestinal obstruction (e.g., due to tumors or hernia) has been confirmed or is suspected at the initiation of elobixibat treatment Patients in whom constipation due to an organic disease is suspected at the initiation of elobixibat treatment *The period from the observation at the start of administration[TO1.1][TS1.2] to the final observation Target Size - 200

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2026 Year 07 Month 16 Day Date of IRB - 2026 Year 08 Month 07 Day Anticipated trial start date - 2026 Year 09 Month 03 Day Last follow-up date - 2026 Year 12 Month 01 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071537

Disclaimer: Curated by HT Syndication.