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A multicenter clinical trial of hydromorphone PCA versus oxycodone oral titration in the treatment of cancer pain

A multicenter randomized controlled clinical trial of hydromorphone injection PCA versus oxycodone sustained release tablets in the treatment of moderate and severe cancer pain

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037845
Enrollment
Unknown
Registered
2020-09-03
Start date
2020-09-09
Completion date
Unknown
Last updated
2020-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer pain

Interventions

Group 1:Subcutaneous PCA titration of hydromorphone
Group 2:Oxycodone oral titration

Sponsors

Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. The subjects volunteered and signed the informed consent of the trial; 2. Patients with cancer pain, aged 18 or more, with no gender limit; 3. Patients with cancer pain and NRS score >= 4 in the past 24 hours; 4. Patients who did not receive radiotherapy during the observation period; 5. Patients who need chemotherapy, long-term hormone therapy, targeted therapy or bisphosphonate therapy have received stable anti-tumor therapy before randomization; 6. Patients or their nursing staff can fill in the survey form; 7. Patients without mental illness who can correctly understand and cooperate with the medication guidance of medical staff; 8. Patients with no history of allergy to narcotic drugs or opiate addiction; 9. Patients with ECOG-ps <= 2; 10. Did not participate in any drug trial within 1 month before the trial.

Exclusion criteria

Exclusion criteria: 1. The patient was diagnosed with non cancerous pain or unexplained pain; 2. Patients with postoperative pain; 3. Paralytic intestinal obstruction; 4. Patients with brain metastases (except those with stable control of brain metastases); 5. Patients with allergic diseases and allergic constitution; those with similar drug structure in the study; and; 6. Patients with abnormal and clinically significant laboratory results, such as creatinine >= 2 times of the upper limit of normal value, ALT or AST >= 2.5 times of the upper limit of normal value (liver metastasis or primary liver cancer >= 5 times of the upper limit of normal value), or child C grade of liver function; 7. Pregnant and lactating women; subjects with pregnancy plan within one month after the trial (including male subjects); 8. Opioid addicts; 9. Patients with cognitive impairment; 10. Patients with severe skin edema, or poor peripheral and subcutaneous circulation, it is not suitable to implant subcutaneous analgesia pump.

Design outcomes

Primary

MeasureTime frame
the time of successful titration;

Secondary

MeasureTime frame
Number of breakthrough pain within 24 and 48 hours;The average pain scores at 24 hours and 48 hours;Number of patients with successful titration at 24 hours and 48 hours;Patient Quality of Life Assessment: Chinese version of the Edmonton Symptom Assessment System;

Countries

China

Contacts

Public ContactYuan Chen

Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

chenyuan008@163.com+86 27-83663407

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026