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

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Drug: Oxycodone; Drug: Morphine

Detailed Description

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
• Enrollment (Actual): 242
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oxycodone Capsules for cancer pain	Drug: Oxycodone; dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days; Other Names: No other name in this study
Active Comparator: Morphine tablets for cancer pain	Drug: Morphine; Morphine tablets 10mg and 20mg, oral every 4-6 hours; Other Names: No other name

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	baseline up to 5-8 days (double blind period)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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.	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	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.	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	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(%).	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(%).	baseline up to 19-22 days (open label treatment)

Collaborators and Investigators

• Sponsor: Mundipharma (China) Pharmaceutical Co. Ltd
• Investigators: Principal Investigator: Shiying Yu, Prof., Wuhan Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: April 25, 2012
• First Submitted That Met QC Criteria: August 27, 2012
• First Posted (Estimate): August 30, 2012

Study Record Updates

• Last Update Posted (Actual): May 21, 2018
• Last Update Submitted That Met QC Criteria: April 19, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Cancer Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Cancer Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine; Oxycodone
• Other Study ID Numbers: OXYC10-CN-303