Cancer PainNCT05962294
Real World Study of Oxycodone Sustained-release Tablets for Patients With Moderate to Severe Cancer Pain
An observational study of Cancer Pain and Real-world Study, run by Henan Cancer Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Pain, Real-world Study, Oxycodone
- How many people
- 916 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 31 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Voluntarily sign an informed consent form;
- Age ≥ 18 years old;
- Patients with moderate to severe (NRS ≥ 4 points) cancer pain;
- Patients with oral equivalent Oxycodone Hydrochloride Sustained-release Tablets ≥ 80mg/d.
Who cannot join
- 1. Patients with severe mental illness who cannot cooperate with follow-up
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450003
Suxia Luo, Doctor, +8618638553211, luosxrm@163.com
About this study
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
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.
Read the 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
- Keywords
- Oxycodone Hydrochloride Sustained-release Tablets
- Medical subject headings
- Cancer Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From the 1st to 14th day of treatment
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.
Measured: From the 1st to 14th day of treatment
Secondary outcomes (4)
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.
Measured: From the 1st to 14th day of treatment
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.
Measured: From the 1st to 14th day of treatment
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.
Measured: On the 3rd, 7th, and 14th days after treatment
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.
Measured: On the 3rd, 7th, and 14th days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Jun 2023
- Primary completion31 May 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 916 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962294
- Sponsor's protocol ID
- TA2023-246
- Status last verified
- Jul 2023
- First submitted
- 6 Jul 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05962294
- Acronym / sponsor ID
- TA2023-246
- Conditions
- Cancer Pain, Real-world Study, Oxycodone
- Keywords
- Oxycodone Hydrochloride Sustained-release Tablets
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 916 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- Voluntarily sign an informed consent form;
- Age ≥ 18 years old;
- Patients with moderate to severe (NRS ≥ 4 points) cancer pain;
- Patients with oral equivalent Oxycodone Hydrochloride Sustained-release Tablets ≥ 80mg/d.
Key exclusion criteria (1 listed)
- 1. Patients with severe mental illness who cannot cooperate with follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean difference in pain intensity after treatment
Time frame: From the 1st to 14th day of 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).
The proportion of patients with effective pain relief
Time frame: From the 1st to 14th day of treatment
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.
4 secondary outcomes
The proportion of patients with effective pain control
Time frame: From the 1st to 14th day of treatment
The time for the patient's pain to be effectively controlled
Time frame: From the 1st to 14th day of treatment
The improvement of patient symptoms
Time frame: On the 3rd, 7th, and 14th days after treatment
The satisfaction with pain control
Time frame: On the 3rd, 7th, and 14th days after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Pain and Real-world Study, run by Henan Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suxia Luo, Doctor (+86 18638553211, luosxrm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean difference in pain intensity after treatment (time frame: From the 1st to 14th day of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.