Cancer pain
Conditions
Interventions
Hydromorphone Hydrochloride Sustained-release Tablets Group:Analgesia was achieved by using hydromoradone hydrochloride sustained-release tablets once every 24 hours
Oxycodone Hydrochloride Sustained-release Tablets Group:Oxycodone hydrochloride sustained-release tablets are used for analgesia, administered once every 12 hours
Sponsors
Xiangyang No.1 People’s Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Provide a signed informed consent form with the date of signature, indicating the willingness to participate in this study; 2. Willingness and compliance to follow all study procedures during the research period; 3. Male or female aged between 18 and 80 years old; 4. Diagnosed with moderate to severe cancer and experiencing persistent pain during treatment, with a pain intensity score of NRS = 4; 5. Good liver and kidney function, with liver function indicators (such as ALT, AST) within the normal range and kidney function indicators (such as creatinine) below 1.5 times the normal value; 6. Ability to take oral medication and willingness to adhere to the medication use protocol of the trial intervention; 7. For women of reproductive potential, they must have used an effective contraceptive method for one month before screening and agree to continue using contraceptive methods during the study period and the additional period specified after the trial intervention; 8. For men of reproductive potential, they must use condoms or other methods to ensure effective contraception for their sexual partners. 9. Agree to abide by lifestyle precautions throughout the study period, such as avoiding the use of other opioid drugs.
Exclusion criteria
Exclusion criteria: 1. Currently using prohibited medications as stipulated in the protocol, such as other potent opioids; 2. Having severe cardiovascular diseases, respiratory diseases or other serious physical conditions; 3. Pregnant or lactating; 4. Known to be allergic to the components of the trial intervention or certain specific components/allergens; 5. Having had a febrile illness or infection within three months prior to screening; 6. Having received other investigational drugs or other interventions for treatment within six months prior to screening; 7. Current smoker or having smoked within three months prior to screening; 8. Other specific diseases (including mental disorders) or physical examination abnormalities that make the subject unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The most severe pain score within the past 24 hours; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of effective analgesia;appraisal of life quality;Incidence of adverse reactions; | — |
Countries
China
Contacts
Public ContactYouhong Dong
Xiangyang No.1 People’s Hospital
Outcome results
None listed