Immediate-Release Oxycodone Capsules Study in Cancer Pain

• ClinicalTrials.gov Identifier: NCT01675622
• Recruitment Status: Completed
• First Posted: August 30, 2012
• Results First Posted: May 21, 2018
• Last Update Posted: May 21, 2018
• Sponsor: Mundipharma (China) Pharmaceutical Co. Ltd
• Information provided by (Responsible Party): Mundipharma (China) Pharmaceutical Co. Ltd

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Cancer	Drug: Oxycodone; Drug: Morphine	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 242 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Comparative Study of Immediate-Release Oxycodone Capsules Versus Immediate-Release Morphine Tablets for the Treatment of Chinese Patients With Cancer Pain.
• Actual Study Start Date: January 2011
• Actual Primary Completion Date: June 2012
• Actual Study Completion Date: July 2012

Arms and Interventions

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 Name: 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 Name: No other name

Outcome Measures

Primary Outcome Measures :

1. Numerical Rating Scale (NRS) [ Time Frame: baseline up to 5-8 days (double blind period) ]
   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.

Secondary Outcome Measures :

1. The Average Dose of Study Medicine Used During Double Blind Treatment Period [ Time Frame: baseline up to 5-8 days (double blind period) ]
   the average dose of study medicine used during double blind treatment period between the two treatment groups.
2. Brief Pain Inventory (BPI) Change From Baseline to After Double Blind Period [ Time Frame: baseline up to 5-8 days (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.
3. Times of Breakthrough Pain Occurrence [ Time Frame: Within 8 days after baseline ]
   the times of breakthrough pain occurrence during double blind treatment phase between the two treatment groups
4. Patient Assessments of Satisfaction for Pain Management [ Time Frame: baseline up to 19-22 days (open label treatment) ]
   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.
5. Average Number of Titrations [ Time Frame: baseline up to 1-3 days(double blind period) ]
   the average times to change the dose in order to find the proper dose between two treatment groups
6. Brief Pain Inventory (BPI) Change From Baseline to Open Label Treatment [ Time Frame: baseline up to 19-22 days (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.
7. the Total Dose of Rescue Medicine for Breakthrough Pain. [ Time Frame: baseline up to 22 days (double blind period) ]
   the total dose of rescue medicine for breakthrough pain during double blind phase between the two treatment groups
8. Degree of Pain Relief Within 24hrs After Treatment [ Time Frame: baseline up to 5-8 days (double blind period) ]
   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(%).
9. Brief Pain Inventory (BPI) Change From Baseline to Open Label Treatment [ Time Frame: baseline up to 19-22 days (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(%).

Eligibility Criteria

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

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.

Contacts and Locations

Sponsors and Collaborators

Mundipharma (China) Pharmaceutical Co. Ltd

Investigators

• Principal Investigator: Shiying Yu, Prof.; Wuhan TongJi Hospital

More Information

• Responsible Party: Mundipharma (China) Pharmaceutical Co. Ltd
• ClinicalTrials.gov Identifier: NCT01675622
• Other Study ID Numbers: OXYC10-CN-303
• First Posted: August 30, 2012
• Results First Posted: May 21, 2018
• Last Update Posted: May 21, 2018
• Last Verified: April 2018

Keywords provided by Mundipharma (China) Pharmaceutical Co. Ltd:

Cancer Pain

Additional relevant MeSH terms:

Cancer Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Morphine; Oxycodone; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents