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Real World Study of Oxycodone/Naloxone Sustained-Release Tablets (Mimeixin) for Patients With Severe Cancer Pain
Sponsor: Henan Cancer Hospital
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
Conditions
Interventions
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