The efficacy of dose titration of OxyNorm™(Oxycodone) immediate-release capsules versus morphine immediate-release tablets in the treatment of cancer pain.
To compare the efficacy of dose titration of OxyNorm™(Oxycodone) immediate-release capsules versus morphine immediate-release tablets in the treatment of cancer pain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
242
Numerical Rating Scale (NRS)
The numerical rating scale is the tool to assess pain level using a numerical rating scale. The primary outcome measurement is the average change of NRS score after double blind treatment between the two treatment groups. The NRS evaluates the pain level using number scale from 0 to 10. 0 means not painful and 10 means extremely painful. 1 to 3 is lightly pain, 4-6 is moderate pain and 7 to 10 is severe pain. There is no subscales used for NRS reporting.
Time frame: baseline up to 5-8 days (double blind period)
The Average Dose of Study Medicine Used During Double Blind Treatment Period
the average dose of study medicine used during double blind treatment period between the two treatment groups.
Time frame: baseline up to 5-8 days (double blind period)
Brief Pain Inventory (BPI) Change From Baseline to After Double Blind Period
The secondary outcome measurement is the change between BPI score at baseline and after completion of double blind treatment between the two treatment groups. The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. This tool measures the worst/least pain in the passed 24 hours, and the average/current pain in last 24 hours. The scale is numerically from 0 to 10. 0 means not painful, 10 means extremely painful. The BPI is the average number of above 4 BPI Pain Items.
Time frame: baseline up to 5-8 days (double blind period)
Times of Breakthrough Pain Occurrence
the times of breakthrough pain occurrence during double blind treatment phase between the two treatment groups
Time frame: Within 8 days after baseline
Patient Assessments of Satisfaction for Pain Management
the number of patients of satisfaction for pain management between the two treatment groups at the end of double blind treatment and the open label treatment period.
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Time frame: baseline up to 19-22 days (open label treatment)
Average Number of Titrations
the average times to change the dose in order to find the proper dose between two treatment groups
Time frame: baseline up to 1-3 days(double blind period)
Brief Pain Inventory (BPI) Change From Baseline to Open Label Treatment
The secondary outcome measurement is the change of BPI score from baseline to the end of open label treatment between the two treatment groups. The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. This tool measures the worst/least pain in passed 24 hours, and the average/current pain in last 24 hours. The scale is numerically from 0 to 10. 0 means not painful, 10 means extremely painful. The BPI is the average number of above 4 BPI Pain Items.
Time frame: baseline up to 19-22 days (open label treatment)
the Total Dose of Rescue Medicine for Breakthrough Pain.
the total dose of rescue medicine for breakthrough pain during double blind phase between the two treatment groups
Time frame: baseline up to 22 days (double blind period)
Degree of Pain Relief Within 24hrs After Treatment
Brief Pain Inventory (BPI) Change From Baseline to After Double Blind Period. The BPI is the average number of above 4 BPI Pain Items. For the degree of pain relief within 24hrs after treatment, 0 means zero relief and 100 means completely relief with unit of percentage(%).
Time frame: baseline up to 5-8 days (double blind period)
Brief Pain Inventory (BPI) Change From Baseline to Open Label Treatment
For the degree of pain relief within 24hrs after treatment, 0 means zero relief and 100 means completely relief with unit of percentage(%).
Time frame: baseline up to 19-22 days (open label treatment)