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Comparing oral hydromorphone hydrochloride sustained-release tablets versus morphine hydrochloride sustained-release tablets for moderate to severe cancer pain after successful Subcutaneous Patient-Controlled Analgesia titration with hydromorphone hydrochloride injection, A randomized, controlled, multicenter clinical study

Comparing oral hydromorphone hydrochloride sustained-release tablets versus morphine hydrochloride sustained-release tablets for moderate to severe cancer pain after successful Subcutaneous Patient-Controlled Analgesia titration with hydromorphone hydrochloride injection, A randomized, controlled, multicenter clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094578
Enrollment
Unknown
Registered
2024-12-25
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Cancer-related pain

Interventions

Group A:Medication, oral hydromorphone hydrochloride sustained release tablets once a day
Group B:Medication, oral morphine hydrochloride sustained release tablets every 12 hours

Sponsors

Affiliated Cancer Hospital of Chongqing University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Subjects voluntarily sign informed consent for this study; 2.Malignant tumor diagnosed by cytopathology or histopathology; 3.Age 18-80, gender unlimited; 4.Patients with clear consciousness ; 5.Cancer-related pain with an NRS score >=4 in the last 24 hours; 6.Patients requiring daily opioid analgesics (MEDD>=40mg) to control moderate to severe cancer pain; 7.The ECOG-PS score of physical condition is 0~3 points;

Exclusion criteria

Exclusion criteria: 1.Patients are non-cancer pain patients or the cause of the pain is unclear; 2.Patients with paralytic ileus; 3.Patients with brain metastases or meningeal metastases accompanied by clinical manifestations of intracranial space occupying effect (headache, dizziness, nausea, vomiting, disturbance of consciousness, seizures, etc.); 4.Abnormal liver and kidney function results (such as creatinine >= 2 times the upper limit of normal, ALT or AST>= 2.5 times the upper limit of normal (liver metastasis patients or primary liver cancer >= 5 times the upper limit of normal), or liver function Child C grade, etc.); 5.Patients with cognitive dysfunction; 6.Patients who cannot be taken orally; 7.Patients who are allergic to opioids; 8.Pregnant or lactating women or patients who plan to have a baby (including men) within 3 months; 9.Patients who are participating in a clinical study (including the drug in the trial) within 1 month before the trial; 10.Patients who chose to receive chemoradiotherapy anti-tumor therapy during the study period; 11.Patients who received radiation therapy at the site of pain within 7 days prior to the trial; 12.Diseases and conditions that researchers consider ineligible.

Design outcomes

Primary

MeasureTime frame
D6 pain score after drug conversion;

Secondary

MeasureTime frame
Patient conversion success rate;Number of break through pain per day;Patient satisfaction evaluation;Score of life quality;Incidence of adverse reactions;

Countries

China

Contacts

Public ContactHuiqing Yu

Chongqing University Cancer Hospital

470480009@qq.com+86 23 6507 9225

Outcome results

None listed

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