Skip to content

Observational study of sustained-release hydromorphone tablets for refractory cancer pain in China

Observational study of sustained-release hydromorphone tablets for refractory cancer pain in China

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114915
Enrollment
Unknown
Registered
2025-12-18
Start date
2025-12-31
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Chronic cancer pain

Interventions

Hydromorphone Extended Release Tablets Group:Hydromorphone Extended Release Tablets
Oxycodone Extended Release Tablets Group:Oxycodone Extended Release Tablets

Sponsors

The second affiliated hospital of Zhejiang University school of medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Patients diagnosed with malignant tumors through cell pathology or tissue pathology, and who are in stage III-IV and unable to undergo surgery or radiotherapy/chemotherapy; 2.Meets the diagnostic criteria for refractory cancer pain, which means that even after standardized use of existing analgesics, the pain is still difficult to control (NRS score >= 4 on the numerical scoring system); 3.Expected survival period>3 months; 4.Age range: 18-80 years old; 5.The patient signs an informed consent form.

Exclusion criteria

Exclusion criteria: 1.There is severe liver and kidney dysfunction (such as transaminase exceeding the upper limit of normal by three times, creatinine clearance rate<30ml/min); 2.History of drug abuse or allergy to opioid drugs; 3.Combining severe mental illness or consciousness disorders, unable to accurately express the degree of pain; 4.Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Incidence and severity of adverse events;Change in pain intensity score (NRS) from baseline after 7 days of treatment;

Secondary

MeasureTime frame
Changes in laboratory inspection indicators;Opioid related symptom score;Patient satisfaction rating;Number of painful outbursts.;Pain relief rate;Quality of life score;

Countries

China

Contacts

Public ContactMin Yan

The second affiliated hospital of Zhejiang University school of medicine

zryanmin@zju.edu.cn+86 571 8778 3716

Outcome results

None listed

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