NCT05962294

Real World Study of Oxycodone Sustained-release Tablets for Patients With Moderate to Severe Cancer Pain

The Efficacy and Safety of Oxycodone Hydrochloride Sustained-release Tablets in the Treatment of Moderate to Severe Cancer Pain：A Multicenter Real World Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 916 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this real world study is to observe the efficacy and safety of Oxycodone Hydrochloride Sustained-release Tablets in the treatment of moderate to severe cancer pain participants in real clinical practice. After entering the study, participants will take Oxycodone Hydrochloride Sustained-release Tablets. The investigators need to observe and record relevant data, and finally analyze and summarize the data to understand the efficacy and safety.

Detailed description

This study is a prospective, single arm, multicenter real world study, the investigators didn't set up a control group. After the participant is enrolled, the participant will enter a 14 day treatment cycle, where the medication will be proportionally converted into Oxycodone Hydrochloride Sustained-release Tablets. The daily medication dose will be adjusted based on the number of pain outbreaks and pain scores (According to the drug increment principle of NCCN), and various information (Daily oxycodone dose, average pain score, minimal pain score, most severe pain score, number of breakout pain, name of rescue drugs, number of rescue, heart rate, blood pressure, respiratory rate, SPO2, combination of drugs, pain control satisfaction, etc) about the participant's medication will be recorded. The participant will not be limited to whether to combine medication. Observe the efficacy and safety of Oxycodone Hydrochloride Sustained-release Tablets.

Conditions

• Cancer Pain
• Real-world Study
• Oxycodone

Timeline

• Start date: 2023-06-01
• Primary completion: 2024-05-31
• Completion: 2024-07-31
• First posted: 2023-07-27
• Last updated: 2023-07-27

Locations

1 site across 1 country: China