Immediate-Release Oxycodone Capsules Study in Cancer Pain

NCT ID: NCT01675622

Last Updated: 2018-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 242 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-07-31

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.

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Oxycodone Capsules for cancer pain

Group Type: EXPERIMENTAL

Oxycodone

Intervention Type: DRUG

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

Morphine tablets for cancer pain

Group Type: ACTIVE_COMPARATOR

Morphine

Intervention Type: DRUG

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

Interventions

Oxycodone

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

Intervention Type: DRUG

Morphine

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

Intervention Type: DRUG

Other Intervention Names

No other name in this study; No other name

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mundipharma (China) Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shiying Yu, Prof.

Role: PRINCIPAL_INVESTIGATOR

Wuhan TongJi Hospital

Other Identifiers

OXYC10-CN-303

Identifier Type: -

Identifier Source: org_study_id