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

Cancer Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05962294
• Other study ID #: TA2023-246
• Status: Recruiting
• Start date: June 1, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: July 2023
• Source: Henan Cancer Hospital
• Contact: Suxia Luo, Doctor
• Phone: +86 18638553211
• Email: luosxrm[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 916
• Est. completion date: July 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Voluntarily sign an informed consent form;

2. Age = 18 years old;

3. Patients with moderate to severe (NRS = 4 points) cancer pain;

4. Patients with oral equivalent Oxycodone Hydrochloride Sustained-release Tablets = 80mg/d.

Exclusion Criteria:

1. Patients with severe mental illness who cannot cooperate with follow-up

Related Conditions & MeSH terms

• Cancer Pain
• Oxycodone
• Real-world Study

Locations

Country	Name	City	State
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean difference in pain intensity after treatment	Use the Numeric Rating Scale(NRS, 0 to 10 points, lower scores indicate better pain control) to evaluate the average pain score per day over the past 24 hours. Calculate the daily difference in pain intensity (PID) by subtracting the daily NRS score from the baseline NRS score. Divide the sum of PID on days 1 to 14 by 14 to obtain the mean difference in pain intensity (MPID).	From the 1st to 14th day of treatment
Primary	The proportion of patients with effective pain relief	Effective pain relief is defined as a decrease of 30% or more in average pain intensity from day 1 to day 14 compared to the baseline period.	From the 1st to 14th day of treatment
Secondary	The proportion of patients with effective pain control	The proportion of patients whose pain is under control. It requires the Numeric Rating Scale (NRS, 0 to 10 points, lower scores indicate better pain control) is = 3 points, and the break-through cancer pain is = 3 times per day.	From the 1st to 14th day of treatment
Secondary	The time for the patient's pain to be effectively controlled	The time from the beginning of treatment to effective pain control for patients. It requires the Numeric Rating Scale (NRS, 0 to 10 points, lower scores indicate better pain control) is = 3 points, and the break-through cancer pain is = 3 times per day.	From the 1st to 14th day of treatment
Secondary	The improvement of patient symptoms	We use the Brief Pain Inventory (BPI) to evaluate the improvement of patient symptoms. There are a total of 7 projects, with each project scoring 0-10 points. The lower the score, the more significant the improvement in symptoms.	On the 3rd, 7th, and 14th days after treatment
Secondary	The satisfaction with pain control	0-10 points (the higher the score, the higher the satisfaction), participants can rate treatment satisfaction based on the efficacy and safety of the experimental drug. It's the patient's subjective perception of pain control.	On the 3rd, 7th, and 14th days after treatment