Study Evaluating Safety and Tolerability of Oxycodone in Patients With Moderate to Severe Cancer Pain

This study is to evaluate the safety and tolerability of oxycodone control-released (CR) and/or immediate-released (IR) use in patients with moderate to severe cancer pain in a 3-months period in Taiwan.

Sex

All

Minimum age

20 Years

Inclusion Criteria:

1. Cancer patients aged 20 years old and over
2. ECOG ≤ 2
3. Moderate to severe pain intensity (NRS pain score ≥ 4)
4. Cancer-related pain that requires treatment with continuous around-the-clock strong opioid analgesic
5. Patients who will not be treated with radiotherapy within 7 days prior to screening and during study
6. Patients or his/her caregivers who are able to fill out the questionnaire forms
7. Patient provided signed informed consent

Exclusion Criteria:

1. Patients diagnosed with non-cancer pain or unexplained pain
2. Patients who cannot be applicable for oral administration
3. Patients who have constipation (CTCAE grade 3 and above)
4. Patients with evidence of significant structural/functional abnormalities of GI tract or planned to undergo surgeries that have high risk lead to gastrointestinal stenosis, blind loop or gastrointestinal obstruction during study
5. Abnormal lab results, with obvious clinical significance, such as the creatinine ≥ 2 fold of upper limit of normal value, or ALT or AST ≥ 2.5 fold of upper limit of normal value (≥ 5 fold, to the patients with liver metastasis or primary liver cancer), or liver function of Child C grade prior to study
6. Pregnant or nursing (lactating) women
7. Patients who are drug or alcohol abuse
8. Patients with moderate to severe psychiatric problems
9. Patients who have hypersensitivity to oxycodone
10. Patients who are clinically unstable or have a life expectancy of less than three months making completion of the trial unlikely

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