Cancer pain
Conditions
Interventions
Group A:After two weeks of oral hydrocodone hydrochloride sustained-release tablets, patients were given two weeks of oxycodone hydrochloride sustained-release tablets. They then chose to continue eit
Group B:After two weeks of oral oxycodone hydrochloride sustained-release tablets, patients were given two weeks of oral hydrocodone hydrochloride sustained-release tablets. Subsequently, patients cou
Sponsors
Chinese People's Liberation Army Eastern Theater Command General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subject voluntarily signed the informed consent for this clinical observation. 2. Age 18-75, gender unspecified. 3. Patients must meet both criteria: (1) Persistent pain with a digital score >=4; and (2) Failure to achieve satisfactory pain relief within 1-2 weeks despite adherence to cancer pain management guidelines and treatment with non-opioid, weak opioid, or combination opioid medications. 4. The main cause of pain is physical rather than mental and psychological factors. 5. The expected survival period is >=3 months. 6. Participants must understand the study process and assessment, be able to describe symptoms objectively, and follow the drug dose and visit schedule.
Exclusion criteria
Exclusion criteria: 1. Those who do not meet the inclusion criteria, or those who are deemed by the physician to be unsuitable for participation in this trial. 2. During the clinical observation period, new anti-tumor drugs or new radiotherapy regimens are started. 3. Patients who cannot communicate verbally; those with cognitive impairment or mental illness; or those with intracranial metastases and impaired consciousness; or those with impaired consciousness due to other causes. 4. Any clinically significant laboratory abnormalities, such as creatinine levels >=2 times the upper limit of normal, ALT or AST levels >=2.5 times the upper limit of normal (for patients with liver metastases, this may be relaxed to >=5 times the upper limit of normal), or liver function grade C per Child's classification. 5. subjects with a history of alcohol abuse, substance abuse, and/or opioid abuse. 6. individuals with allergic diseases or a predisposition to allergies; or those with a history of hypersensitivity to drugs structurally similar to the investigational drug. 7. Contraindications of the test drug: such as digestive tract perforation, obstruction, etc. 8. Patients who have participated in a clinical trial within 3 months before the trial (including the drug in this trial). 9. Women who are not in menopause and women who are in menopause within one year are required to undergo a urine pregnancy test and obtain a recorded positive result before the first administration of the study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NRS score; | — |
Secondary
| Measure | Time frame |
|---|---|
| The percentage of patients who chose either a sustained-release hydrocodone hydrochloride tablet or a sustained-release oxycodone hydrochloride tablet after completing cross-treatment;The proportion of two groups choosing either a sustained-release hydrocodone hydrochloride tablet or a sustained-release oxycodone hydrochloride tablet after completing cross-treatment.;Daily equivalent oral morphine dose;Daily outbreak pain frequency;Cumulative number of remedial medications;Economic evaluation indicators;Patient symptom assessment: Edmonton symptom scale;Sleep quality assessment: Pittsburgh Sleep Quality Index;Adverse reactions or other adverse events, serious adverse events; | — |
Countries
China
Contacts
Public ContactLiu Hongjun
Chinese People's Liberation Army Eastern Theater Command General Hospital
Outcome results
None listed