Cancer Pain
Conditions
Interventions
test group:hydrochloride oxycodone controlled-release tablets with dose titration at 12h for cancer pain
Control group:hydrochloride oxycodone controlled-release tablets with dose titration at 24h for cancer pain
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 years and more; 2. Patients with cancer as evidenced by clinical diagnosis and/or pathological diagnosis; 3. The mean pain intensity (NRS) during the past 24 hours = 4 points; 4. The patients who are intolerable to opioids (including the patients without a long-term use of opioids as the daily basic medications); therefore, there is no manifestation of obvious tolerance either. Defined by FDA, patients who are considered opioid-tolerant are those who have been taking at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily for a week or longer); 5. The patients who can orally take drugs and are judged by the investigator to be suitable to use the Oxycodone sustained-release tablet simplified titration; 6. The patients can rule out the influence of anti-tumor treatment (radiotherapy, chemotherapy, and targeted therapy etc.) on the analgesic effects during the analgesic drug dose adjustment; 7. Using release morphine analgesia to relive breakthrongh pain at least 1 time within first 12h; 8. The patients who have a clear mind and can understand the guidance of doctors medication regimen; 9. The patients must understand the study process and evaluation, agree to participate in this trial, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating patients; 2. The patients known to be allergic to any other component in Oxycodone or investigational drug; 3. The patients have the pain irrelevant with the tumor or the pain with unclear causes, such as osteoarthritis-induced pain, and low back pain; 4. Emergency treatment due to tumorous pain; 5. Complicated tumorous pain or intractable tumorous pain; 6. Patients with refractory constipation; 7. The patients have taken monoamine oxidase inhibitors (MAOIs) or this type of drugs within 2 weeks; 8. The patients have potential gastrointestinal diseases and/or the risk of surgical treatment, which may induce gastrointestinal stenosis, blind loop or gastrointestinal tract obstruction; 9. The patients with unstable concomitant diseases; or the patients with important organ dysfunction; 10. The patients with infection, abscess or fever symptoms; 11. The patients with liver and renal functional abnormalities, such as the creatinine value is not less than 2 times of the upper limit of normal values or ALT or AST is not less than 2.5 times of the upper limit of normal values (as for the patients with hepatic metastasis, it is not less than 5 times of the upper limit of normal values); 12. The patients taking anti-epileptic or antiarrhythmic drugs; 13. The patients who have the contraindications of Oxycodone or Morphine, adverse drug reactions (ADR) and drug interactions as stated in the package insert or investigators brochure; 14. The patients with a history of drug or alcohol abuse; 15. The patients who participate in another compound clinical trial study within 1 month before the study; 16. The patients who may change the combined medications (excluding those used to treat the adverse reactions of opioids) during the study; 17. The patients who are unsuitable to participate in this study due to any reason other than the inclusion criteria and exclusion criteria according to the judgment of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the proportion of patients with pain remission 24h after the titration;the proportion of patients with pain remission 48h and 72h after the titration; | — |
Secondary
| Measure | Time frame |
|---|---|
| QoL;Safety;Rescue analgesic medications within first 24h,48h and 72h;The investigators and patients evaluated the satisfaction of treatment; | — |
Countries
China
Contacts
Public ContactSong Zhengbo
Zhejiang Cancer Hospital
Outcome results
None listed