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NOT YET RECRUITING
NCT06897917
PHASE4

Real World Study of Oxycodone/Naloxone Sustained-Release Tablets (Mimeixin) for Patients With Severe Cancer Pain

Sponsor: Henan Cancer Hospital

View on ClinicalTrials.gov

Summary

This study is a prospective, single-arm, multicenter, real-world study to evaluate effect of bowel function, analgesic effect, quality of life, and safety of Mimeixin® in Chinese patients with severe cancer pain.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

203

Start Date

2025-04

Completion Date

2025-12

Last Updated

2025-03-27

Healthy Volunteers

No

Interventions

DRUG

Oxycodone Hydrochloride and Naloxone Hydrochloride Sustained-release Tablets

1. Calculate the total opioid dosage administered to the patient in the previous 24 hours and convert it to an equivalent dose of oxycodone/naloxone sustained-release tablets(Mimeixin). 2. Based on the principle of incremental dosing, calculate the total dosage to be administered on the day of enrollment, divide it into two portions, and administer one portion every 12 hours (q12h). 3. In case of breakthrough pain during treatment, administer an equivalent dose of immediate-release morphine or other medications equivalent to 10%-20% of the 24-hour background dosing for relief. 4. If the number of breakthrough pain events exceeds 2 in a day after dosing, adjust the dosage again based on the incremental dosing principle. Adjustments should be made every 1-2 days, with each adjustment increasing the dose by a gradient of 5 mg/2.5 mg or 10 mg/5 mg of oxycodone/naloxone sustained-release tablets, twice daily, and so on. The maximum daily dose of oxycodone should not exceed 160 mg.

Locations (1)

Henan Cancer Hospital

Zhengzhou, Henan, China