Tokyo, Dec. 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059932) titled 'An Exploratory Observational Study on the Prescription Patterens for the Treatment of Gastrointestinal Adverse Events Following the Prescription of Mild Opioid Analgesics in Non-Cancer Pain Patients' on Dec. 5.

Study Type: Observational

Primary Sponsor: Institute - Shionogi & Co., Ltd.

Condition: Condition - Opioid Induced Constipation Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To exploratorily investigate the prescription patterns of therapeutic agents for gastrointestinal adverse events in patients initiated weak opioid analgesics. Basic objectives2 - Others

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1.Patients who were prescribed weak opioid analgesics (tramadol hydrochloride, tramadol-acetaminophen combination, codeine, Buprenorphine) for non-cancer pain from April 2017 to March 2024. 2.Patients who had a visit after week 13 following the initial prescription of weak opioid analgesics Patients with all of the following data -Patient demographics (age, gender, underlying condition causing pain) -Prescription information of weak opioid analgesics (prescription date, drug name, prescribed dosage (/day)) Key exclusion criteria - 1.Patients who have declined participation in this study (opt-out method) 2.Patients with opioid analgesics up to 4 weeks before starting weak opioid analgesics 3.Patients who have a diagnosis of cancer (excluding carcinoma in situ) at the time of starting weak opioid analgesics Target Size - 2000

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2024 Year 10 Month 11 Day Date of IRB - 2024 Year 10 Month 15 Day Anticipated trial start date - 2025 Year 05 Month 31 Day Last follow-up date - 2025 Year 05 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068188

Disclaimer: Curated by HT Syndication.