Clinical trial NCT05962294: Real World Study of Oxycodone Sustained-release Tablets for Patients With Moderate to Severe Cancer Pain
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer Pain
Real-world Study
Oxycodone
Keywords: Oxycodone Hydrochloride Sustained-release Tablets
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2023-07-27
Enrollment: 916
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief 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.

Eligibility 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

Primary outcomes:
measure: Mean difference in pain intensity after treatment
timeFrame: From the 1st to 14th day of treatment
measure: The proportion of patients with effective pain relief
timeFrame: From the 1st to 14th day of treatment
Secondary outcomes:
measure: The proportion of patients with effective pain control
timeFrame: From the 1st to 14th day of treatment
measure: The time for the patient's pain to be effectively controlled
timeFrame: From the 1st to 14th day of treatment
measure: The improvement of patient symptoms
timeFrame: On the 3rd, 7th, and 14th days after treatment
measure: The satisfaction with pain control
timeFrame: On the 3rd, 7th, and 14th days after treatment
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
Study officials:
References: