Cancer PainNCT07869797
Real-world Study of the Effectiveness and Tolerability of Outpatient Titration of OxyContin for the Moderate and Severe Pain in Cancer Patients
An observational study of Cancer Pain, run by Mundipharma (China) Pharmaceutical Co. Ltd at 20 sites in China.
Trial summary
The purpose of this observational study is to evaluate the effectiveness and tolerability of outpatient titration regimen with OxyContin as background for moderate and severe pain in cancer patients in adult patients with moderate to severe cancer pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Pain
- How many people
- 378 participants
- Where
- 20 sitesChina
- Study dates
- Oct 2026to Apr 2027
- How long will I take part?
- 8 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult patients with moderate-to-severe cancer pain treated with the outpatient OxyContin dose titration regimen，able to complete questionnaire and scale assessments.
Who may be able to join
- Male or female cancer participants, age ≥ 18 years
- Participants presenting with moderate to severe (NRS ≥ 4 points) cancer-related pain
- Participants undergoing outpatient titration regimen with OxyContin as background, see Appendix 3
- Voluntarily sign an informed consent form
Who cannot join
- Participants with cognitive impairment, delirium, psychiatric disorders, or other conditions that may interfere with reliable pain self-assessment
- Participants are receiving surgery or minimally invasive interventional pain management
- Participants are not willing to cooperate in completing follow-up
- The investigator judges as unsuitable for inclusion in the study
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
China20 sites
Cancer Hospital Chinese Academy of Medical Scienc
Beijing
Minghua Cong, +86 150 0104 8699, doccong@vip.163.com
Minghua Cong
Cangzhou Central Hospital
Cangzhou
Geng Zhang, +86 13931734888, 958666492@qq.com
Geng Zhang
The First Hospital of Jilin University
Changchun
Jiuwei Cui, +86 15843073215, cuijw@jlu.edu.cn
Jiuwei Cui
Hunan Cancer Hospital
Changsha
Zhiguo Zhou, +86 15388009098, zhouzhiguo@hnca.org.cn
Zhiguo Zhou
Sichuan Cancer Hospital
Chengdu
Yang Wei, +86 17708177615, 2576168359@qq.com
Yang Wei
The Affiliated Cancer Hospital of Chongqing University
Chongqing
Yongsheng Li, +86 17784310187, yongshengli2005@163.com
Yongsheng Li
Fujian Cancer Hospital
Fuzhou
Zhiyong He, +86 13805086391, Heyong1015@163.com
Zhiyong He
Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences)
Guangzhou
Jian Xiao, +86 13711114566, xiaojian@gdph.org.cn
Jian Xiao
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou
Ying Dong, +86 13666669105, 3032426226@qq.com
Ying Dong
Zhejiang Cancer Hospital
Hangzhou
Zhiyong Shi, +86 15906664718, shizhiyong027@163.com
Zhiyong Shi
Qilu Hospital of Shandong University
Jinan
Jianfeng Wang, +86 18560086002, Wangjianfeng123456@126.com
Jianfeng Wang
The First Affiliated Hospital of Nanchang University
Nanchang
Jiangsu Cancer Hospital
Nanjing
Yang Yang, +86 13813988672, jszlyyyy@163.com
Yang Yang
Nanjing Drum Tower Hospital
Nanjing
Rutian Li, +86 13813863961, rutianli@nju.edu.cn
Rutian Li
Qingdao Traditional Chinese Medicine Hospital
Qingdao
Xiaotao Zhang, +86 18669710019, sabr@vip.163.com
Xiaotao Zhang
Affiliated Cancer Hospital of Dalian University of Technology (Liaoning Cancer Hospital & Institute)
Shenyang
Wenyao Cui, +86 18509860120, wenyaoc@163.com
Wenyao Cui
Shenzhen Second People's Hospital
Shenzhen
Geng Tian, +86 13724395569, tiangeng666@aliyun.com
Geng Tian
The Second Hospital of Hebei Medical University
Shijiazhuang
Guangzhao Liu, +86 15803210979, liuguangzhao100@sina.com
Guangzhao Liu
Shaanxi Cancer Hospital
Xi'an
Xiaoquan Chen, +86 13186141921, 2435350357@qq.com
Xiaoquan Chen
Henan Cancer Hospital
Zhengzhou
Guanglun Xie, +86 13939029792, xieguanglun@126.com
Guanglun Xie
About this study
The purpose of this observational study is to evaluate the effectiveness and tolerability of outpatient titration regimen with OxyContin as background for moderate and severe pain in cancer patients in adult patients with moderate to severe cancer pain. The main questions it aims to answer are
- To evaluate the effectiveness of titration regimen with OxyContin as background for the moderate and severe pain in cancer participants
- To explore the tolerability of titration regimen with OxyContin as background use in outpatient participants with moderate and severe cancer pain
Read the detailed description
Primary Endpoints: The proportion of participants achieving pain remission, which is defined as the rate of participants with average NRS (Numerical rating scale) score ≤3 [CR (Complete remission)] or achieving a reduction of 25% when NRS score >3 [PR (Partial remission)] at 72 h.
Secondary Endpoints:
- The proportions of participants with CR and PR at 24h and 48h
- Time-to-first CR and PR
- The respective proportions of participants with no rescue medication use at 24h, 48h, and 72h
- Pain severity subscale score, interference of pain subscale score from the BPI-SF
- The average titration dosage of OxyContin
- The average maintenance dosage of OxyContin
- Adverse events: the frequency and severity of adverse event
- Conditions
- Cancer Pain
- Keywords
- moderate and severe pain in cancer patients, outpatient titration of OxyContin, Real-world study, effectiveness and tolerability
- Medical subject headings
- Cancer Pain, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Outpatient OxyContin Dose Titration for Patients with Moderate-to-Severe Cancer Pain | Outpatient OxyContin Dose Titration for Patients with Moderate-to-Severe Cancer Pain，This study is a multi-center prospective single arm real-world study with OxyContin as background titration. The study consists of 2 phases: Screening/ titration phase and maintenance phase. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants achieving pain relief after treatment.
Pain assessments will be performed using the BPI-SF (Brief Pain Inventory-Short Form) and NRS (Numerical Rating Scale).
The proportion of participants achieving pain remission, which is defined as the rate of participants with average NRS (Numerical rating scale) score ≤3 [CR (Complete remission)] or achieving a reduction of 25% when NRS score >3 [PR (Partial remission)] at 72 h
Measured: From enrollment to the end of follow-up at Day 8.
Secondary outcomes (1)
Adverse events: the frequency and severity of adverse events
assessed primarily by adverse events occurring after treatment (defined as adverse events that emerge or worsen following the first dose of OxyContin), and may also be evaluated via physical examinations and vital signs.
Measured: From enrollment to the end of follow-up at Day 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 378 participants (estimated)
- Target duration
- 8 Days
Sponsor and investigators
- Lead sponsor
- Mundipharma (China) Pharmaceutical Co. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tigermed Consulting Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Minghua Cong, MD, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869797
- Sponsor's protocol ID
- OXY26-CN-501
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared with other researchers, due to privacy protection and ethical considerations. Study results may be published in the form of aggregated summary data.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Study of the Effectiveness and Tolerability of Outpatient Titration of OxyContin for the Moderate and Severe Pain in Cancer Patients
- ClinicalTrials.gov ID
- NCT07869797
- Acronym / sponsor ID
- OXY26-CN-501
- Conditions
- Cancer Pain
- Keywords
- moderate and severe pain in cancer patients, outpatient titration of OxyContin, Real-world study, effectiveness and tolerability
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 378 participants (estimated)
- Lead sponsor
- Mundipharma (China) Pharmaceutical Co. LtdIndustry (pharma, biotech, devices)
- Collaborators
- Tigermed Consulting Co., Ltd
- Study start
- Oct 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 13 Oct 2026 (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 purpose of this observational study is to evaluate the effectiveness and tolerability of outpatient titration regimen with OxyContin as background for moderate and severe pain in cancer patients in adult patients with moderate to severe cancer pain. The main questions it aims to answer are
- To evaluate the effectiveness of titration regimen with OxyContin as background for the moderate and severe pain in cancer participants
- To explore the tolerability of titration regimen with OxyContin as background use in outpatient participants with moderate and severe cancer pain
Detailed description
Primary Endpoints: The proportion of participants achieving pain remission, which is defined as the rate of participants with average NRS (Numerical rating scale) score ≤3 [CR (Complete remission)] or achieving a reduction of 25% when NRS score >3 [PR (Partial remission)] at 72 h.
Secondary Endpoints:
- The proportions of participants with CR and PR at 24h and 48h
- Time-to-first CR and PR
- The respective proportions of participants with no rescue medication use at 24h, 48h, and 72h
- Pain severity subscale score, interference of pain subscale score from the BPI-SF
- The average titration dosage of OxyContin
- The average maintenance dosage of OxyContin
- Adverse events: the frequency and severity of adverse event
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Outpatient OxyContin Dose Titration for Patients with Moderate-to-Severe Cancer Pain | – | –Outpatient OxyContin Dose Titration for Patients with Moderate-to-Severe Cancer Pain，This study is a multi-center prospective single arm real-world study with OxyContin as background titration. The study consists of 2 phases: Screening/ titration phase and maintenance phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with moderate-to-severe cancer pain treated with the outpatient OxyContin dose titration regimen，able to complete questionnaire and scale assessments.
Key inclusion criteria (4 listed)
- Male or female cancer participants, age ≥ 18 years
- Participants presenting with moderate to severe (NRS ≥ 4 points) cancer-related pain
- Participants undergoing outpatient titration regimen with OxyContin as background, see Appendix 3
- Voluntarily sign an informed consent form
Key exclusion criteria (4 listed)
- Participants with cognitive impairment, delirium, psychiatric disorders, or other conditions that may interfere with reliable pain self-assessment
- Participants are receiving surgery or minimally invasive interventional pain management
- Participants are not willing to cooperate in completing follow-up
- The investigator judges as unsuitable for inclusion in the study
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
The proportion of participants achieving pain relief after treatment.
Time frame: From enrollment to the end of follow-up at Day 8.
Pain assessments will be performed using the BPI-SF (Brief Pain Inventory-Short Form) and NRS (Numerical Rating Scale). The proportion of participants achieving pain remission, which is defined as the rate of participants with average NRS (Numerical rating scale) score ≤3 [CR (Complete remission)] or achieving a reduction of 25% when NRS score >3 [PR (Partial remission)] at 72 h
1 secondary outcome
Adverse events: the frequency and severity of adverse events
Time frame: From enrollment to the end of follow-up at Day 8.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared with other researchers, due to privacy protection and ethical considerations. Study results may be published in the form of aggregated summary data.
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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.
Minghua Cong, MD principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
20 sites 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, run by Mundipharma (China) Pharmaceutical Co. Ltd at 20 sites 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 4 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: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gang Peng (+86 13699158703, Gang.Peng@mundipharma.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of participants achieving pain relief after treatment. (time frame: From enrollment to the end of follow-up at Day 8.). 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 13 Oct 2026.