CancerPhase 3NCT01675622
Immediate-Release Oxycodone Capsules Study in Cancer Pain
A Phase 3 study testing Oxycodone and Morphine in people with Cancer, run by Mundipharma (China) Pharmaceutical Co. Ltd.
Trial summary
The efficacy of dose titration of OxyNorm™(Oxycodone) immediate-release capsules versus morphine immediate-release tablets in the treatment of cancer pain. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cancer
- What is being tested?
- Oxycodone and Morphine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Jul 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of either sex aged 18 to 80 years inclusive, who with cancers of all type.
- Patients with moderate to severe cancer pain, whose pain intensity Numeric Rating Scale ≥4.
- Patients who can understand and are able to complete Numeric Rating Scale and Brief Pain Inventory assessment.
- Patients who have given written informed consent to participate in the study.
Who cannot join
- Patients who are pregnant, or lactating.
- Patients who are unable to manage their pain effectively with opioids.
- Patient who need ≥120mg morphine or equivalent for treatment of pain at time of study entry;
- 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).
- 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.
- 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.
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- Patients with other unstable disease, or with dysfunction of important organ.
- Patients with an ongoing infection, abscess or fever.
- Patient with serious abnormal liver/ renal function (ALT/Aspartate Transaminase/creatinine/urea nitrogen) which is higher than 3 times of upper limit;
- Paralytic or mechanical ileus;
- Persistent asthma, chronic obstructive diseases, and cor pulmonary;
- Intracranial neoplasms, and intracranial hypertension with central respiratory depression risk.
- Monoamine oxidase inhibitors (MAOIs) or same type drugs have been administered in last 2 weeks;
- Patients who are currently taking active treatment for epilepsy or arrhythmias.
- Patients with known sensitivity or record of specific or allergic reaction to oxycodone or morphine.
- 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.
- Patients with a history of drug or alcohol abuse.
- Patients who participated in another clinical research study involving a new chemical entity within one month prior to study entry.
- Patients whose concomitant medication is likely to be changed within the study period, with the exception of treatment for opioid side effects.
- 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.
About this study
Official title: 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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxycodoneDrug
Also called No other name in this study
dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days
MorphineDrug
Also called No other name
Morphine tablets 10mg and 20mg, oral every 4-6 hours
| Study group | Role | What they receive |
|---|---|---|
| Oxycodone Capsules for cancer pain | Experimental | Not described Receives: Drug: Oxycodone |
| Morphine tablets for cancer pain | Active comparator | Not described Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline up to 5-8 days (double blind period)
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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(%).
Measured: 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(%).
Measured: baseline up to 19-22 days (open label treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2012 (estimated)
- Study startJan 2011
- Primary completionJun 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mundipharma (China) Pharmaceutical Co. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shiying Yu, Prof., Principal investigator, Wuhan TongJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01675622
- Sponsor's protocol ID
- OXYC10-CN-303
- Status last verified
- Apr 2018
- First submitted
- 25 Apr 2012
- Last updated
- 21 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Immediate-Release Oxycodone Capsules Versus Immediate-Release Morphine Tablets for the Treatment of Chinese Patients With Cancer Pain.
- ClinicalTrials.gov ID
- NCT01675622
- Acronym / sponsor ID
- OXYC10-CN-303
- Conditions
- Cancer
- Keywords
- Cancer Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Mundipharma (China) Pharmaceutical Co. LtdIndustry (pharma, biotech, devices)
- Study start
- Jan 2011 (actual)
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 30 Aug 2012 (estimated)
- Results
- Posted 21 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxycodone Capsules for cancer pain | Experimental | Drug: Oxycodone |
| Morphine tablets for cancer pain | Active comparator | Drug: Morphine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of either sex aged 18 to 80 years inclusive, who with cancers of all type.
- Patients with moderate to severe cancer pain, whose pain intensity Numeric Rating Scale ≥4.
- Patients who can understand and are able to complete Numeric Rating Scale and Brief Pain Inventory assessment.
- Patients who have given written informed consent to participate in the study.
Key exclusion criteria (20 listed)
- Patients who are pregnant, or lactating.
- Patients who are unable to manage their pain effectively with opioids.
- Patient who need ≥120mg morphine or equivalent for treatment of pain at time of study entry;
- 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).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxycodoneAlso: No other name in this studydosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days | Drug | Oxycodone Capsules for cancer pain |
| MorphineAlso: No other nameMorphine tablets 10mg and 20mg, oral every 4-6 hours | Drug | Morphine tablets for cancer pain |
Primary outcome
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.
9 secondary outcomes
The Average Dose of Study Medicine Used During Double Blind Treatment Period
Time frame: baseline up to 5-8 days (double blind period)
Brief Pain Inventory (BPI) Change From Baseline to After Double Blind Period
Time frame: baseline up to 5-8 days (double blind period)
Times of Breakthrough Pain Occurrence
Time frame: Within 8 days after baseline
Patient Assessments of Satisfaction for Pain Management
Time frame: baseline up to 19-22 days (open label treatment)
Average Number of Titrations
Time frame: baseline up to 1-3 days(double blind period)
Brief Pain Inventory (BPI) Change From Baseline to Open Label Treatment
Time frame: baseline up to 19-22 days (open label treatment)
the Total Dose of Rescue Medicine for Breakthrough Pain.
Time frame: baseline up to 22 days (double blind period)
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 Open Label Treatment
Time frame: baseline up to 19-22 days (open label treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shiying Yu, Prof. principal investigator
Wuhan TongJi Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oxycodone and Morphine in people with Cancer, run by Mundipharma (China) Pharmaceutical Co. Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale (NRS) (time frame: baseline up to 5-8 days (double blind period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2018.