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A multi-center, randomized controlled study of opioids by titration of different administration routes in the treatment of moderate to severe cancer pain

A multi-center, randomized controlled study of opioids by titration of different administration routes in the treatment of moderate to severe cancer pain

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045210
Enrollment
Unknown
Registered
2021-04-08
Start date
2021-04-10
Completion date
Unknown
Last updated
2021-11-16

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

Conditions

cancer pain

Interventions

Group A:hydromorphone intravenous PCA
Group B:Oxycodone oral

Sponsors

People's Hospictal of Jiangxi Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The subjects volunteered and signed the informed consent of the trial; 2. Tissue or pathology diagnosed as cancer; 3. Aged >= 18 years and = 4 in the past 24 hours; 5. Patients who had not received radiation therapy within 7 days prior to randomization and trial; 6. Patients with no history of allergy to narcotic drugs; 9. Patients with ECOG-ps <= 3.

Exclusion criteria

Exclusion criteria: 1. The patient was diagnosed with non cancerous pain or unexplained pain; 2. Paralytic intestinal obstruction; 3. Patients with metastatic brain cancer with cerebral symptoms; 4. 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; 5. Cognition impairment ; 6. Participate in drug trials (including this drug) within 1 month prior to the trial; 7. Diseases and conditions that other researchers consider ineligible for inclusion.

Design outcomes

Primary

MeasureTime frame
Success rate of titration on the first one;Time of successful titration;

Secondary

MeasureTime frame
Success rate of titration on the second?the third day;Symptoms Improved Conditions (ESAS Scale);Satisfaction with pain control;Pain score of transition of hydromorphone to oral oxycodone after intravenous PCA titration and the proportion of successful conversion;

Countries

China

Contacts

Public ContactYao Weirong

People's Hospictal of Jiangxi Province

13907002901@126.com+86 13907002901

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026