Immediate-Release Oxycodone Capsules Study in Cancer Pain

Phase 3

Completed

• Conditions: Cancer
• Interventions: Drug: Oxycodone; Drug: Morphine

• Registration Number: NCT01675622
• Lead Sponsor: Mundipharma (China) Pharmaceutical Co. Ltd

Brief Summary

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

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 Timeline

• Study Start: 2011-01
• Study First Submitted: 2012-04-25
• Primary Completion: 2012-06
• Study Completion: 2012-07
• Study First Submitted QC: 2012-08-27
• Study First Posted: 2012-08-30
• Results First Submitted: 2017-11-17
• Status Verified: 2018-04
• Results First Submitted QC: 2018-04-19
• Last Update Submitted: 2018-04-19
• Results First Posted: 2018-05-21
• Last Update Posted: 2018-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 242

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxycodone Capsules for cancer pain	Oxycodone	-
Morphine tablets for cancer pain	Morphine	-

Primary Outcome Measures

Name	Time	Method
Numerical Rating Scale (NRS)	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

Name	Time	Method
Average Number of Titrations	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
Brief Pain Inventory (BPI) Change From Baseline to Open Label Treatment	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(%).
The Average Dose of Study Medicine Used During Double Blind Treatment Period	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.
the Total Dose of Rescue Medicine for Breakthrough Pain.	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
Degree of Pain Relief Within 24hrs After Treatment	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(%).
Brief Pain Inventory (BPI) Change From Baseline to After Double Blind Period	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.
Times of Breakthrough Pain Occurrence	Within 8 days after baseline	the times of breakthrough pain occurrence during double blind treatment phase between the two treatment groups
Patient Assessments of Satisfaction for Pain Management	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.