Real-world Study of the Effectiveness and Tolerability of Outpatient Titration of OxyContin for the Moderate and Severe Pain in Cancer Patients

ConditionCancer Pain
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMundipharma (China) Pharmaceutical Co. Ltd

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 population

Adult patients with moderate-to-severe cancer pain treated with the outpatient OxyContin dose titration regimen,able to complete questionnaire and scale assessments.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

378 Participants
are grouped into 1 trial group
Group A: Outpatient OxyContin Dose Titration for Patients with Moderate-to-Severe Cancer Pain

Trial outcomes

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.

Other outcomes

Sponsors and contacts

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Mundipharma (China) Pharmaceutical Co. Ltd

Lead sponsor

Tigermed Consulting Co., Ltd

Collaborator

This trial is not recruiting at the moment. You can still explore other options: