Moderate to severe cancer pain
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Pain requirements: Moderate to severe chronic cancer pain caused by malignant tumors or their treatment (baseline 24-hour average pain intensity Digital scale (NRS) >=4 points). 2. History of opioid use: No strong opioid drugs have been used, or weak opioids (such as codeine, tramadol) or low-dose strong opioid drugs (such as morphine ready-to-release tablets = 3 months.
Exclusion criteria
Exclusion criteria: 1. Allergy to the study drug or its components; severe liver or kidney dysfunction (specific indicators need to be clarified); 2. Severe respiratory depression or acute exacerbation of chronic obstructive pulmonary disease; 3. Uncontrolled epilepsy; increased intracranial pressure; 4. Concurrent use of monoamine oxidase inhibitors; 5. Presence of cognitive or psychiatric disorders that may interfere with pain assessment or study compliance; 6. Pregnant or breastfeeding women; 7. Other conditions deemed by the investigator as unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in the average daily maximum severe pain intensity (NRS) from baseline at the 4th week of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse reactions;living quality;The changes of NRS at each time point within 12 weeks; | — |
Countries
China
Contacts
The First Affiliated Hospital of Xi'an Jiaotong University