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Trial Title:
Real World Study of Oxycodone Sustained-release Tablets for Patients With Moderate to Severe Cancer Pain
NCT ID:
NCT05962294
Condition:
Cancer Pain
Real-world Study
Oxycodone
Conditions: Official terms:
Cancer Pain
Conditions: Keywords:
Oxycodone Hydrochloride Sustained-release Tablets
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
This study is a prospective, single arm, multicenter real-world study that only needs to
meet the requirements of age, disease type, drug dosage, and no severe mental illness in
the study population
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450003
Country:
China
Status:
Recruiting
Contact:
Last name:
Suxia Luo, Doctor
Phone:
+8618638553211
Email:
luosxrm@163.com
Start date:
June 1, 2023
Completion date:
July 31, 2024
Lead sponsor:
Agency:
Henan Cancer Hospital
Agency class:
Other
Source:
Henan Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05962294
