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CompletedNCT01675622Updated May 21, 2018Results posted

Immediate-Release Oxycodone Capsules Study in Cancer Pain

A Phase 3 interventional study of Oxycodone and Morphine in Cancer, sponsored by Mundipharma (China) Pharmaceutical Co. Ltd. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-05-21.

Sponsored by Mundipharma (China) Pharmaceutical Co. Ltd · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Jan 2011, registered Apr 2012).
Phase
Phase 3
Study type
Interventional
Enrollment
242
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Cancer

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Keywords

  • Cancer Pain
03

In context

Cancer Pain

338 studies on the registry are indexed under Cancer Pain; 71 are open to participants now.

This study's enrollment of 242 is above the median of 60 across 254 interventional studies indexed under Cancer Pain.

Browse Cancer Pain studies →

Lead sponsor

Mundipharma (China) Pharmaceutical Co. Ltd is the lead sponsor of 18 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
242 participants (actual)

Study arms

  • Experimental
    Oxycodone Capsules for cancer pain

    Drug: Oxycodone

  • Active comparator
    Morphine tablets for cancer pain

    Drug: Morphine

Interventions

  • DrugOxycodone

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

    Also known as: No other name in this study

  • DrugMorphine

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

    Also known as: No other name

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline up to 5-8 days (double blind period)

Secondary outcomes

  1. 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.

    Time frame: baseline up to 5-8 days (double blind period)

  2. 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.

    Time frame: baseline up to 5-8 days (double blind period)

  3. Times of Breakthrough Pain Occurrence

    the times of breakthrough pain occurrence during double blind treatment phase between the two treatment groups

    Time frame: Within 8 days after baseline

  4. 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.

    Time frame: baseline up to 19-22 days (open label treatment)

  5. Average Number of Titrations

    the average times to change the dose in order to find the proper dose between two treatment groups

    Time frame: baseline up to 1-3 days(double blind period)

  6. 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.

    Time frame: baseline up to 19-22 days (open label treatment)

  7. 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

    Time frame: baseline up to 22 days (double blind period)

  8. 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(%).

    Time frame: baseline up to 5-8 days (double blind period)

  9. 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(%).

    Time frame: baseline up to 19-22 days (open label treatment)

07

Results

Posted May 21, 2018

Participant flow

A total of 242 subjects were enrolled from 20 centers in which 192 subjects completed the study and 50 subjects did not completed the study. All the subjects were recruited from medical clinic.The recruitment period is from 2011 Jan to 2012 Mar.

Participant flow — Overall Study
MilestoneOxycodone Capsules for Cancer PainMorphine Tablets for Cancer Pain
Started122120
Completed9696
Not completed2624
Withdrew: Withdrawal by subject22
Withdrew: Adverse event1210
Withdrew: Protocol violation41
Withdrew: Lack of efficacy24
Withdrew: Lost to follow-up13
Withdrew: Other54

Outcome measures

PrimaryNumerical 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.

Time frame:
baseline up to 5-8 days (double blind period)
Reported as:
Mean · scores on a scale
Numerical Rating Scale (NRS)
scores on a scaleOxycodone Capsules for Cancer PainMorphine Tablets for Cancer Pain
Numerical Rating Scale (NRS)3.91 ± 2.313.87 ± 2.22
SecondaryThe 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.

Time frame:
baseline up to 5-8 days (double blind period)
Reported as:
Mean · mg
The Average Dose of Study Medicine Used During Double Blind Treatment Period
mgOxycodone Capsules for Cancer PainMorphine Tablets for Cancer Pain
Average total dosage during double-blind titration83.29 ± 82.87141.61 ± 112.10
Ave. total dosage during double-blind maintenance167.41 ± 103.92308.63 ± 189.93
SecondaryBrief 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.

Time frame:
baseline up to 5-8 days (double blind period)
Reported as:
Mean · scores on a scale
Brief Pain Inventory (BPI) Change From Baseline to After Double Blind Period
scores on a scaleOxycodone Capsules for Cancer PainMorphine Tablets for Cancer Pain
Highest pain intensity in 24 hrs4.25 ± 1.984.03 ± 2.20
Lowest pain intensity in 24 hrs2.62 ± 2.082.53 ± 1.98
Average pain intensity in 24 hrs3.39 ± 1.803.35 ± 1.73
Current Pain intensity3.78 ± 1.943.70 ± 1.88
SecondaryTimes of Breakthrough Pain Occurrence

the times of breakthrough pain occurrence during double blind treatment phase between the two treatment groups

Time frame:
Within 8 days after baseline
Reported as:
Number · breakthrough pain events
Times of Breakthrough Pain Occurrence
breakthrough pain eventsOxycodone Capsules for Cancer PainMorphine Tablets for Cancer Pain
Times of Breakthrough Pain Occurrence1520
SecondaryPatient 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.

Time frame:
baseline up to 19-22 days (open label treatment)
Reported as:
Count of participants · Participants
Patient Assessments of Satisfaction for Pain Management
ParticipantsOxycodone Capsules for Cancer PainMorphine Tablets for Cancer Pain
Very satisfied3537
Satisfied6461
Neutral95
Dissatisfied14
Missing1111
SecondaryAverage Number of Titrations

the average times to change the dose in order to find the proper dose between two treatment groups

Time frame:
baseline up to 1-3 days(double blind period)
Reported as:
Mean · dose changes
Average Number of Titrations
dose changesOxycodone Capsules for Cancer PainMorphine Tablets for Cancer Pain
Average Number of Titrations8.25 ± 4.527.89 ± 3.43
SecondaryBrief 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.

Time frame:
baseline up to 19-22 days (open label treatment)
Reported as:
Mean · scores on a scale
Brief Pain Inventory (BPI) Change From Baseline to Open Label Treatment
scores on a scaleOxycodone Capsules for Cancer PainMorphine Tablets for Cancer Pain
Highest pain intensity in 24 hrs3.98 ± 2.093.95 ± 1.92
Lowest pain intensity in 24 hrs2.57 ± 2.052.64 ± 1.98
Average pain intensity in 24 hrs3.33 ± 1.833.48 ± 1.57
Current Pain intensity3.62 ± 1.873.71 ± 1.57
Secondarythe 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

Time frame:
baseline up to 22 days (double blind period)
Reported as:
Mean · mg
the Total Dose of Rescue Medicine for Breakthrough Pain.
mgOxycodone Capsules for Cancer PainMorphine Tablets for Cancer Pain
the total dose of rescue medicine -day110.63 ± 7.767.00 ± 4.83
the total dose of rescue medicine -day210.00 ± 8.296.00 ± 2.07
the total dose of rescue medicine-day310.63 ± 8.216.82 ± 2.52
the total dose of rescue medicine-day420.00 ± 8.947.86 ± 3.93
the total dose of rescue medicine-day511.00 ± 10.846.67 ± 4.08
the total dose of rescue medicine -day60 ± 05.00 ± 0.00
the total dose of rescue medicine after day65.00 ± 05.00 ± 0.00
SecondaryDegree 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(%).

Time frame:
baseline up to 5-8 days (double blind period)
Reported as:
Mean · percentage of pain relief
Degree of Pain Relief Within 24hrs After Treatment
percentage of pain reliefOxycodone Capsules for Cancer PainMorphine Tablets for Cancer Pain
Degree of Pain Relief Within 24hrs After Treatment35.23 ± 28.2734.19 ± 30.85
SecondaryBrief 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(%).

Time frame:
baseline up to 19-22 days (open label treatment)
Reported as:
Mean · percentage of pain relief
Brief Pain Inventory (BPI) Change From Baseline to Open Label Treatment
percentage of pain reliefOxycodone Capsules for Cancer PainMorphine Tablets for Cancer Pain
Brief Pain Inventory (BPI) Change From Baseline to Open Label Treatment32.31 ± 30.8031.64 ± 29.73

Adverse events

Collected over up to 36 days. Non-serious events are listed at a 0.0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Oxycodone Capsules for Cancer Pain2/120 (1.7%)4/120 (3.3%)76/120 (63.3%)
Morphine Tablets for Cancer Pain2/118 (1.7%)2/118 (1.7%)75/118 (63.6%)
Most frequent serious events
Most frequent serious events
EventOxycodone Capsules for Cancer PainMorphine Tablets for Cancer Pain
Respiratory and circulatory failureRespiratory, thoracic and mediastinal disorders2/1202/118
ileusGastrointestinal disorders1/1200/118
Brain metastasesNervous system disorders1/1200/118
Most frequent other events
Showing 10 of 16
Most frequent other events
EventOxycodone Capsules for Cancer PainMorphine Tablets for Cancer Pain
ConstipationGastrointestinal disorders38/12043/118
NauseaGastrointestinal disorders25/12026/118
VomitingGastrointestinal disorders25/12024/118
DizzinessNervous system disorders9/1206/118
FeverImmune system disorders8/1204/118
DrowsinessNervous system disorders8/1204/118
DysuriaRenal and urinary disorders3/1206/118
Loss of appetiteNervous system disorders5/1203/118
CoughRespiratory, thoracic and mediastinal disorders4/1204/118
Pulmonary infectionRespiratory, thoracic and mediastinal disorders3/1204/118

Baseline characteristics

Age, Continuous
Age, Continuous(years)Oxycodone Capsules for Cancer PainMorphine Tablets for Cancer PainTotal
Mean56.62 ± 12.9657.05 ± 12.0756.83 ± 12.50
Sex: Female, Male
Sex: Female, Male(Participants)Oxycodone Capsules for Cancer PainMorphine Tablets for Cancer PainTotal
Female5859117
Male6259121
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Oxycodone Capsules for Cancer PainMorphine Tablets for Cancer PainTotal
American Indian or Alaska Native000
Asian119117236
Native Hawaiian or Other Pacific Islander000
Black or African American000
White000
More than one race112
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(Participants)Oxycodone Capsules for Cancer PainMorphine Tablets for Cancer PainTotal
China120118238
height
height(centimeter)Oxycodone Capsules for Cancer PainMorphine Tablets for Cancer PainTotal
Mean164.5 ± 7.45164.99 ± 8.20164.74 ± 7.82
weight
weight(kg)Oxycodone Capsules for Cancer PainMorphine Tablets for Cancer PainTotal
Mean58.64 ± 10.7958.34 ± 11.0158.49 ± 10.88
08

Study locations

No study locations are listed for this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01675622
Lead sponsor
Mundipharma (China) Pharmaceutical Co. Ltd
Responsible party
Sponsor
First posted
Aug 30, 2012
Start date
Jan 2011
Primary completion
Jun 2012
Completion
Jul 2012
Results posted
May 21, 2018
Last update
May 21, 2018

Study contacts

Shiying Yu, Prof.
principal investigator · Wuhan TongJi Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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