Clinical trial NCT01675622: Immediate-Release Oxycodone Capsules Study in Cancer Pain
Official title: A Comparative Study of Immediate-Release Oxycodone Capsules Versus Immediate-Release Morphine Tablets for the Treatment of Chinese Patients With Cancer Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cancer
Keywords: Cancer Pain
Lead sponsor: Mundipharma (China) Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2012-08-30
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.
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.

Primary outcomes:
measure: Numerical Rating Scale (NRS)
timeFrame: baseline up to 5-8 days (double blind period)
Secondary outcomes:
measure: The Average Dose of Study Medicine Used During Double Blind Treatment Period
timeFrame: baseline up to 5-8 days (double blind period)
measure: Brief Pain Inventory (BPI) Change From Baseline to After Double Blind Period
timeFrame: baseline up to 5-8 days (double blind period)
measure: Times of Breakthrough Pain Occurrence
timeFrame: Within 8 days after baseline
measure: Patient Assessments of Satisfaction for Pain Management
timeFrame: baseline up to 19-22 days (open label treatment)
measure: Average Number of Titrations
timeFrame: baseline up to 1-3 days(double blind period)
measure: Brief Pain Inventory (BPI) Change From Baseline to Open Label Treatment
timeFrame: baseline up to 19-22 days (open label treatment)
measure: the Total Dose of Rescue Medicine for Breakthrough Pain.
timeFrame: baseline up to 22 days (double blind period)
measure: Degree of Pain Relief Within 24hrs After Treatment
timeFrame: baseline up to 5-8 days (double blind period)
measure: Brief Pain Inventory (BPI) Change From Baseline to Open Label Treatment
timeFrame: baseline up to 19-22 days (open label treatment)
Other outcomes:
Locations:
Study officials:
affiliation: Wuhan TongJi Hospital
name: Shiying Yu, Prof.
role: PRINCIPAL_INVESTIGATOR
References: