Immediate-Release Oxycodone Capsules Study in Cancer Pain
Condition: Cancer
MeSH terms: Cancer Pain
Intervention: Oxycodone; Morphine
Intervention description: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days; Morphine tablets 10mg and 20mg, oral every 4-6 hours
Intervention MeSH terms: Morphine; Oxycodone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 242.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Cancer Pain

Summary:

      The efficacy of dose titration of OxyNorm™(Oxycodone) immediate-release capsules versus
      morphine immediate-release tablets in the treatment of cancer pain.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients of either sex aged 18 to 80 years inclusive, who with cancers of all type.

          2. Patients with moderate to severe cancer pain, whose pain intensity Numeric Rating
             Scale ≥4.

          3. Patients who can understand and are able to complete Numeric Rating Scale and Brief
             Pain Inventory assessment.

          4. Patients who have given written informed consent to participate in the study.

        Exclusion Criteria:

          1. Patients who are pregnant, or lactating.

          2. Patients who are unable to manage their pain effectively with opioids.

          3. Patient who need ≥120mg morphine or equivalent for treatment of pain at time of study
             entry;

          4. Patients who are receiving chemotherapy, or still under the responsive period of
             chemotherapy (patients who are at the interval period of chemotherapy can be enrolled
             into study. That is to say, patients who completed chemotherapy for more than 2 weeks
             can enrolled, or patients has completed chemotherapy for at least one week could be
             enrolled at the discretion of the investigator).

          5. Patients who have received radio-therapy for bony metastasis, patients receiving
             radiotherapy within the 4 week period before study entry (patient receiving
             radiotherapy for area other than pain area can be enrolled) , or patients who were
             scheduled to receive radiotherapy for pain area during study period.

          6. Patients are receiving or should receive anti-convulsion drugs/anti- depression drugs
             considered by investigator for the treatment of neuropathy pain. Patients are
             receiving or should receive any analgesic other than study medicine, which including
             NSAIDs.

          7. Patients with other unstable disease, or with dysfunction of important organ.

          8. Patients with an ongoing infection, abscess or fever.

          9. Patient with serious abnormal liver/ renal function (ALT/Aspartate
             Transaminase/creatinine/urea nitrogen) which is higher than 3 times of upper limit;

         10. Paralytic or mechanical ileus;

         11. Persistent asthma, chronic obstructive diseases, and cor pulmonary;

         12. Intracranial neoplasms, and intracranial hypertension with central respiratory
             depression risk.

         13. Monoamine oxidase inhibitors (MAOIs) or same type drugs have been administered in last
             2 weeks;

         14. Patients who are currently taking active treatment for epilepsy or arrhythmias.

         15. Patients with known sensitivity or record of specific or allergic reaction to
             oxycodone or morphine.

         16. Patients excluded by the contra-indications, adverse drug reaction (ADRs) and drug
             interactions of oxycodone or morphine as detailed in the data sheet, summary of
             product characteristics or investigator's brochure.

         17. Patients with a history of drug or alcohol abuse.

         18. Patients who participated in another clinical research study involving a new chemical
             entity within one month prior to study entry.

         19. Patients whose concomitant medication is likely to be changed within the study period,
             with the exception of treatment for opioid side effects.

         20. Patients who, in the opinion of the investigator, are unsuitable to participate in the
             study for any other reason not mentioned in the inclusion and exclusion criteria.