Symptoms and General Pathology

All Conditions

Nervous System Diseases

Cancer Pain

Pain

Neurologic Manifestations

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Oxycodone

Morphine

Analgesics, Opioid

Narcotics

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

Shiying Yu, Prof.

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.

Immediate-Release Oxycodone Capsules Study in Cancer Pain

A Comparative Study of Immediate-Release Oxycodone Capsules Versus Immediate-Release Morphine Tablets for the Treatment of Chinese Patients With Cancer Pain.

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.

the average dose of study medicine used during double blind treatment period between the two treatment groups.

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.

the times of breakthrough pain occurrence during double blind treatment phase between the two treatment groups

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.

the average times to change the dose in order to find the proper dose between two treatment groups

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.

the total dose of rescue medicine for breakthrough pain during double blind phase between the two treatment groups

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(%).

For the degree of pain relief within 24hrs after treatment, 0 means zero relief and 100 means completely relief with unit of percentage(%).

Mundipharma (China) Pharmaceutical Co. Ltd

The AE collection period including maximally 7 days screening and 5 to 8 days double blind period, and then 14 days open treatment period. 7 days safety follow up.

Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days

Oxycodone Capsules for Cancer Pain

Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours

Morphine Tablets for Cancer Pain

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

China

Region of Enrollment

height

weight

Director of R&D

Numerical Rating Scale (NRS)

Average total dosage during double-blind titration

Ave. total dosage during double-blind maintenance

The average total dosage during double-blind treatment was defined as a primary efficacy endpoint in the protocol, but this study was a non-inferiority study, and non-inferiority analysis could not be performed in average total dosage in data processing and statistics.

The Average Dose of Study Medicine Used During Double Blind Treatment Period

Highest pain intensity in 24 hrs

Lowest pain intensity in 24 hrs

Average pain intensity in 24 hrs

Current Pain intensity

Brief Pain Inventory (BPI) Change From Baseline to After Double Blind Period

Times of Breakthrough Pain Occurrence

Patient Assessments of Satisfaction for Pain Management

Dosing change frequency for complete titration

Average Number of Titrations

Brief Pain Inventory (BPI) Change From Baseline to Open Label Treatment

the total dose of rescue medicine -day1

the total dose of rescue medicine -day2

the total dose of rescue medicine-day3

the total dose of rescue medicine-day4

the total dose of rescue medicine-day5

the total dose of rescue medicine -day6

the total dose of rescue medicine after day6

The double-blind titration period was the dose adjusting phase, so breakthrough pain occurrences in this period were not included in statistical analysis. After titration was completed, subjects entered into maintenance treatment with the titrated dose.

the Total Dose of Rescue Medicine for Breakthrough Pain.

Degree of Pain Relief Within 24hrs After Treatment

Oxycodone: dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days. All patients completed the double-blind treatment entered into period 2.

period 2 is open treatment phase. Patients received two weeks treatment of oxycodone hydrochloride controlled-release tablets.

Morphine: Morphine tablets 10mg and 20mg, oral every 4-6 hours. All patients completed the double-blind treatment entered into period 2.

period 2 is open treatment phase. Patients received two weeks treatment of oxycodone hydrochloride controlled-release tablets.

Spots Global Cancer Trial Database for Immediate-Release Oxycodone Capsules Study in Cancer Pain

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