ClinicalTrials.gg
Not yet recruitingNCT07869797Updated Oct 13, 2026

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 in Cancer Pain, sponsored by Mundipharma (China) Pharmaceutical Co. Ltd. Not yet recruiting at 20 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Mundipharma (China) Pharmaceutical Co. Ltd (part of Mundipharma) · Observational

Updated Oct 13, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
378
Ages
18 Years and older
Sex
All
01

Study 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. 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
02

Conditions studied

  • Cancer Pain

Keywords

  • moderate and severe pain in cancer patients
  • outpatient titration of OxyContin
  • Real-world study
  • effectiveness and tolerability
03

In context

Cancer Pain

343 studies on the registry are indexed under Cancer Pain; 74 are open to participants now.

This study's planned enrollment of 378 is above the median of 140 across 70 observational studies indexed under Cancer Pain.

Browse Cancer Pain studies →

Lead sponsor

Mundipharma (China) Pharmaceutical Co. Ltd is the lead sponsor of 19 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
378 participants (estimated)
Target follow-up
8 Days
Patient registry
Yes

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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.

    Time frame: From enrollment to the end of follow-up at Day 8.

07

Study locations

20 sites
  • Cancer Hospital Chinese Academy of Medical Scienc
    Beijing, China
    • Minghua Cong · Contact · doccong@vip.163.com · +86 150 0104 8699
    • Minghua Cong · Principal investigator
  • Cangzhou Central Hospital
    Cangzhou, China
    • Geng Zhang · Contact · 958666492@qq.com · +86 13931734888
    • Geng Zhang · Principal investigator
  • The First Hospital of Jilin University
    Changchun, China
    • Jiuwei Cui · Contact · cuijw@jlu.edu.cn · +86 15843073215
    • Jiuwei Cui · Principal investigator
  • Hunan Cancer Hospital
    Changsha, China
  • Sichuan Cancer Hospital
    Chengdu, China
    • Yang Wei · Contact · 2576168359@qq.com · +86 17708177615
    • Yang Wei · Principal investigator
  • The Affiliated Cancer Hospital of Chongqing University
    Chongqing, China
  • Fujian Cancer Hospital
    Fuzhou, China
    • Zhiyong He · Contact · Heyong1015@163.com · +86 13805086391
    • Zhiyong He · Principal investigator
  • Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences)
    Guangzhou, China
  • The Second Affiliated Hospital Zhejiang University School of Medicine
    Hangzhou, China
    • Ying Dong · Contact · 3032426226@qq.com · +86 13666669105
    • Ying Dong · Principal investigator
  • Zhejiang Cancer Hospital
    Hangzhou, China
  • Qilu Hospital of Shandong University
    Jinan, China
  • The First Affiliated Hospital of Nanchang University
    Nanchang, China
  • Jiangsu Cancer Hospital
    Nanjing, China
    • Yang Yang · Contact · jszlyyyy@163.com · +86 13813988672
    • Yang Yang · Principal investigator
  • Nanjing Drum Tower Hospital
    Nanjing, China
    • Rutian Li · Contact · rutianli@nju.edu.cn · +86 13813863961
    • Rutian Li · Principal investigator
  • Qingdao Traditional Chinese Medicine Hospital
    Qingdao, China
    • Xiaotao Zhang · Contact · sabr@vip.163.com · +86 18669710019
    • Xiaotao Zhang · Principal investigator
  • Affiliated Cancer Hospital of Dalian University of Technology (Liaoning Cancer Hospital & Institute)
    Shenyang, China
    • Wenyao Cui · Contact · wenyaoc@163.com · +86 18509860120
    • Wenyao Cui · Principal investigator
  • Shenzhen Second People's Hospital
    Shenzhen, China
  • The Second Hospital of Hebei Medical University
    Shijiazhuang, China
  • Shaanxi Cancer Hospital
    Xi'an, China
    • Xiaoquan Chen · Contact · 2435350357@qq.com · +86 13186141921
    • Xiaoquan Chen · Principal investigator
  • Henan Cancer Hospital
    Zhengzhou, China
    • Guanglun Xie · Contact · xieguanglun@126.com · +86 13939029792
    • Guanglun Xie · Principal investigator
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07869797
Collaborators
Tigermed Consulting Co., Ltd
Responsible party
Sponsor
First posted
Oct 13, 2026
Start date
Oct 2026 (estimated)
Primary completion
Apr 2027 (estimated)
Completion
Apr 2027 (estimated)
Last update
Oct 13, 2026

Study contacts

Gang Peng
Contact
Gang.Peng@mundipharma.com.cn
+86 13699158703
Xu Chen
Contact
xu.chen@tigermedgrp.com
+86 18019947155
Minghua Cong, MD
principal investigator · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion