Cancer pain
Conditions
Interventions
titration group of Oxycodone Hydrochloride:Oxycodone Hydrochloride
Sponsors
Sir Run Run Shaw Hospital, Medical school, Zhejiang University
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Tumor patients aged over 18 years old(including 18); 2) The patients, with moderate or severe cancer pain, are currently administrating strong opioid analgesics and the pain has not been controlled effectively. Or, the patients in the same class are currently administrating weak opioid analgesics, but the strong opioid analgesics, which belong to the third step in the WHO three-step analgesic ladder for cancer pain relief, are needed for their pain relief; 3) The subjects have to or expect to have oral administration of 40 mg or more or equivalent dose of morphine in every 24 hrs; 4) The patients, who will not be treated with chemotherapy, radiotherapy, targeting therapy, hormone therapy or bisphosphonate therapy 3 days before randomization or during overall course of the study, will be preferentially enrolled; 5) For the patients who need long term administration of hormone or targeting therapy or bisphosphonates therapy, the treatments will maintain from 3 days prior to randomization to end of the study as much as possible; 6) For patients who need radiotherapy or chemotherapy, these therapies should be conducted during maintaining phase and completed as assuring as possible before last follow-up; 7) For patients treated with radiotherapy, the tumor location under radiotherapy should not be that for evaluation of pain.
Exclusion criteria
Exclusion criteria: 1) The pure neuropathic pain or unexplained pain; 2) The pain that only occurs during moving; 3) Acute pain; 4) The patients who are receiving or received treatment with radioactive isotopes 3 days prior to randomization or during the maintaining phase; 5) The patients who can not be applicable for oral administration; 6) There were no defecation in first 5 days during the screen phase; 7) The patients with obvious CNS disease; 8) Any disease that may lead to respiration inhibition of the subjects; 9) Monoamine oxidase inhibitor (MAOI) was administrated one week before randomization; 10) There are abnormal results, with obvious clinical significance, from lab testing, such as the creatinine is =2-fold of upper limit of normal value, or ALT or AST is =2-fold of upper limit of normal value, or liver function is Child C grade; 11) There are potential gastrointestinal diseases or the risk of surgical operation, which may lead to gastrointestinal stenosis, blind loop or gastrointestinal obstruction; 12) The prolonged-release oxycodone tablets or other strong opioids drugs have been treated before.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The cycles of tiration(the ratio of successful titration less than 2-3 cycles); | — |
Secondary
| Measure | Time frame |
|---|---|
| the ratio of adverse event;the ratio of titration of 1-4 cycles;the ratio of titration falure rat; | — |
Countries
China
Contacts
Public ContactPan Hongming
Outcome results
None listed