Moderate to Severe Cancer Pain
Conditions
Interventions
Extended-release hydromorphone tablet group:Extended-release hydromorphone tablets
Extended-release hydromorphone tablet combined with traditional Chinese medicine directional transdermal drug delivery group:Based on the extended-release hydromorphone tablet group, traditional Chine
Sponsors
Shanxi Research Institute of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1) The subjects voluntarily sign the informed consent form for this trial; 2) Patients with a histological or pathological diagnosis of malignant tumors; 3) Aged 18 - 80 years, conscious, regardless of gender; 4) Patients with moderate to severe cancer pain who need to use opioid analgesics daily for control; 5) ECOG-PS score; 6) The anti-tumor drugs do not change within 1 month before the trial.
Exclusion criteria
Exclusion criteria: 1) The subjects voluntarily sign the informed consent form for this trial; 2) Patients with a histological or pathological diagnosis of malignant tumors; 3) Aged 18 - 80 years, conscious, regardless of gender; 4) Patients with moderate to severe cancer pain who need to use opioid analgesics daily for control; 5) ECOG-PS score; 6) The anti-tumor drugs do not change within 1 month before the trial. 1) Patients diagnosed with non-cancerous pain or pain of unknown origin; 2) Patients with brain metastases and accompanied by brain symptoms; 3) Patients with contraindications to the trial drugs, such as those accompanied by paralytic ileus, chronic obstructive pulmonary disease, and cor pulmonale; 4) Patients with refractory cancer pain such as severe neuropathic cancer pain; 5) Abnormal laboratory results with obvious clinical significance, such as creatinine = 2 times the upper limit of the normal value, ALT or AST = 2.5 times the upper limit of the normal value (5 times the upper limit of the normal value for patients with liver metastases or primary liver cancer), or liver function at Child C level; 6) Severe cognitive impairment; 7) Pregnant or lactating patients; 8) Patients allergic to the test drug; 9) Patients unable to take oral medications; 10) Participated in a drug trial (including the test drug) within 1 month before the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean difference in pain intensity from days 1 to 6 post-treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Effective rate of analgesia;Daily drug dosage;Number of breakthrough pain episodes per day;Satisfaction evaluation;Quality of life assessment; | — |
Countries
China
Contacts
Public ContactHao Shulan
Shanxi Research Institute of Traditional Chinese Medicine
Outcome results
None listed