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CompletedNCT01719757PROBEUpdated Aug 19, 2016Results posted

PROspective Non-interventional Open laBEl Trial for TARGIN in Korean Patients With Cancer Pain

A Phase 4 interventional study of Oxycodone/Naloxone in Cancer, sponsored by Mundipharma Korea Ltd. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2016-08-19.

Sponsored by Mundipharma Korea Ltd · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
359
Allocation
Not applicable
Ages
20 Years and older
Sex
All
01

Study summary

The aim of the study is to evaluate the efficacy of TARGIN administration as an analgesic to Korean patients treated with opioid analgesics for moderate-to-severe cancer pain under conditions of daily practice.

Read the detailed description

An open-label, multi-center, nonrandomized, prospective, non-interventional, observational phase IV trial.

At the first visit, a detailed medical history is taken, including previous analgesics and concomitant treatment. After inclusion, patients enter a 4-week observation period during which they will receive bid of TARGIN 10/5mg and/or 20/10mg. The dose adjustments of TARGIN as well as of analgesic co-medication, rescue-medication and other treatments (e.g. laxatives) can be performed at any time-point during the observation period by the physician in dependence of medical demand. The asymmetric dose is allowed during the observation period by the physician's judgment. (e.g. 10/5 mg in the morning and 20/10 mg in the evening).

Data are gathered using interview-administered questionnaires at baseline (visit 1) and study end (visit 2).

During the observation period, unscheduled visits are allowed after the first visit due to inadequate pain control or occurrence of adverse events.

02

Conditions studied

  • Cancer

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Keywords

  • Targin, 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 359 is above the median of 60 across 254 interventional studies indexed under Cancer Pain.

Browse Cancer Pain studies →

Lead sponsor

Mundipharma Korea Ltd is the lead sponsor of 16 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
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male or female cancer patients 20 years of age or older
  2. Cancer related pain that requires treatment with continuous around-the-clock strong opioid analgesic
  3. Moderate to severe pain intensity (NRS pain score >=4)
  4. Opioid naïve patients or patients not treated with strong opioids (Only except occasional PRN) within 13 months or patients who has been on weak opioids
  5. Ability to communicate effectively with the study personnel regarding pain intensity, constipation assessment, final assessment of overall efficacy and tolerability
  6. Subject who provide signed and dated written voluntary informed consent

Exclusion criteria

Exclusion Criteria:

  1. Pregnant or nursing (lactating) women
  2. Have previously received treatment with Targin
  3. Patient with evidence of significant structural/functional abnormalities of GI tract which is not appropriate for oral medicine administration
  4. Any history of hypersensitivity to Oxycodone and Naloxone or any excipients
  5. Patients with significant respiratory depression
  6. Patients with acute or severe bronchial asthma or hypercarbia
  7. Any patient who has or is suspected of having paralytic ileus
  8. Severe Chronic obstructive pulmonary disease, pulmonary heart disease
  9. Targin product contains lactose. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take
  10. Patients with moderate and severe hepatic impairment
  11. Abnormal aspartate aminotransferase (AST; SGOT), alanine aminotransferase (ALT; SGPT), or alkaline phosphatase levels (>2.5 times the upper limit of normal, it is allowed >5 times the upper limit of normal in case of transition in liver) or an abnormal total bilirubin and/or creatinine level(s) (greater than 1.5 times the upper limit of normal)
  12. Any situation where opioids are contraindicated
  13. With a life expectancy \< 1 month
  14. Any situation where opioids are contraindicated
  15. Mainly pain originated other than cancer or cancer related conditions (eg. Musculoskeletal pain, inflammatory pain, diabetic polyneuropathy)
  16. Patients with known or suspected unstable brain metastases or spinal cord compression that may require changes in steroid treatment throughout the duration of the study
  17. Patients with uncontrolled seizures
  18. Requiring interventional treatment for pain such as neurodestructive procedure or regional infusion
  19. With a history of alcohol abuse within 6 months of screening
  20. With a history of illicit drug abuse within 6 months of screening
  21. Patients with increased intracranial pressure
  22. Having used other investigational drugs at the time of enrollment, or within 30 days.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
359 participants (actual)

Study arms

  • Experimental
    Oxycodone/naloxone

    Trade name is Targin. Oxycodone (10mg)/naloxone (5mg) or Oxycodone (20mg)/naloxone (10mg) tablets. Twice daily per oral. Dose adjustment and asymmetric dose are allowed up to 80/40mg per day

    Drug: Oxycodone/Naloxone

Interventions

  • DrugOxycodone/Naloxone

    Twice daily

    Also known as: Targin

06

What researchers measure

Primary outcomes

  1. Change in Numeric Rating Scales (NRS) Score

    Primary objective: Change in numeric rating scales (NRS) such as score for average pain levels over the previous 24 hours, from baseline (visit 1) to study end (visit 2). NRS score was measured from 0 (No pain) to 10(worst pain imaginable).

    Time frame: 4 weeks

Secondary outcomes

  1. Change of Eastern Cooperative Oncology Group(ECOG) Performance Status

    If ECOG P.S score is increased from baseline to visit2, the results mean that QOL was worse. ECOG P.S grade: 0=Fully active, able to carry on all pre-disease performance without restriction, 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work,2=Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours,3=Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours,4=Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair,5=Death.

    Time frame: 4weeks

  2. Change of Constipation Assessment From Baseline to Visit 2(End Visit)

    Constipation assessment(5-point scale; 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe, for the patient's judgment of the intensity of symptoms)

    Time frame: 4 weeks

  3. Overall Satisfaction Assessment About Efficacy and Tolerability of Oxycodone/Naloxone by the Investigator and Subject

    The overall satisfactions by investigators \& subjects were assessed 5 steps such as Very good, Good, Satisfactory, Bad, Very bad.

    Time frame: 4 weeks

07

Results

Posted Aug 19, 2016

Participant flow

Safety set: 359 ITT set: 304

Participant flow — Overall Study
MilestoneOxycodone/Naloxone
Started359
Completed258
Not completed101
Withdrew: Adverse event38
Withdrew: Withdrawal by subject15
Withdrew: Lost to follow-up20
Withdrew: Protocol violation1
Withdrew: Well controlled pain27

Outcome measures

PrimaryChange in Numeric Rating Scales (NRS) Score

Primary objective: Change in numeric rating scales (NRS) such as score for average pain levels over the previous 24 hours, from baseline (visit 1) to study end (visit 2). NRS score was measured from 0 (No pain) to 10(worst pain imaginable).

Time frame:
4 weeks
Reported as:
Mean · units on a scale
Change in Numeric Rating Scales (NRS) Score
units on a scaleOxycodone/Naloxone
Change in Numeric Rating Scales (NRS) Score-1.89 ± 2.16
SecondaryChange of Eastern Cooperative Oncology Group(ECOG) Performance Status

If ECOG P.S score is increased from baseline to visit2, the results mean that QOL was worse. ECOG P.S grade: 0=Fully active, able to carry on all pre-disease performance without restriction, 1=Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work,2=Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours,3=Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours,4=Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair,5=Death.

Time frame:
4weeks
Reported as:
Mean · Score
Change of Eastern Cooperative Oncology Group(ECOG) Performance Status
ScoreOxycodone/Naloxone
Change of Eastern Cooperative Oncology Group(ECOG) Performance Status0.08 ± 0.52
SecondaryChange of Constipation Assessment From Baseline to Visit 2(End Visit)

Constipation assessment(5-point scale; 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe, for the patient's judgment of the intensity of symptoms)

Time frame:
4 weeks
Reported as:
Mean · score
Change of Constipation Assessment From Baseline to Visit 2(End Visit)
scoreOxycodone/Naloxone
Change of Constipation Assessment From Baseline to Visit 2(End Visit)-0.03 ± 0.67
SecondaryOverall Satisfaction Assessment About Efficacy and Tolerability of Oxycodone/Naloxone by the Investigator and Subject

The overall satisfactions by investigators \& subjects were assessed 5 steps such as Very good, Good, Satisfactory, Bad, Very bad.

Time frame:
4 weeks
Reported as:
Number · participants
Overall Satisfaction Assessment About Efficacy and Tolerability of Oxycodone/Naloxone by the Investigator and Subject
participantsInvestigatorSubject
Very good2412
Good8078
Satisfactory146156
Bad5355
Very Bad13

Adverse events

Collected over Safety data were analyzed based on AEs and compliance in the safety set that included subjects who had at least one dose of the study drug and were assessed for safety. Patients were followed safety profile by 4weeks.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Oxycodone/Naloxone—51/359 (14.2%)227/359 (63.2%)
Most frequent serious events
Showing 10 of 38
Most frequent serious events
EventOxycodone/Naloxone
AstheniaGeneral disorders6/359
Abdominal painGastrointestinal disorders5/359
Disease progressionGeneral disorders4/359
NauseaGastrointestinal disorders3/359
PyrexiaGeneral disorders3/359
PneumoniaInfections and infestations3/359
DiarrhoeaGastrointestinal disorders2/359
DyspnoeaRespiratory, thoracic and mediastinal disorders2/359
AnaemiaBlood and lymphatic system disorders2/359
Febrile neutropeniaBlood and lymphatic system disorders2/359
Most frequent other events
Showing 10 of 128
Most frequent other events
EventOxycodone/Naloxone
ConstipationGastrointestinal disorders59/359
NauseaGastrointestinal disorders48/359
Decreased appetiteMetabolism and nutrition disorders36/359
VomitingGastrointestinal disorders25/359
PyrexiaGeneral disorders24/359
DiarrhoeaGastrointestinal disorders22/359
AstheniaGeneral disorders20/359
DizzinessNervous system disorders15/359
Abdominal painGastrointestinal disorders14/359
DyspepsiaGastrointestinal disorders9/359

Baseline characteristics

Safety set

Age, Categorical
Age, Categorical(Participants)Oxycodone/Naloxone
<=18 years0
Between 18 and 65 years179
>=65 years180
Age, Continuous
Age, Continuous(years)Oxycodone/Naloxone
Mean67.73 ± 11.07
Sex: Female, Male
Sex: Female, Male(Participants)Oxycodone/Naloxone
Female134
Male225
Region of Enrollment
Region of Enrollment(participants)Oxycodone/Naloxone
Korea, Republic of359
08

Study locations

1 site
  • 13 sites including Yeungnam University Medical Center
    Daegu, 705-717, Korea, Republic of
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01719757
Lead sponsor
Mundipharma Korea Ltd
Responsible party
Sponsor
First posted
Nov 1, 2012
Start date
Jul 2012
Primary completion
Oct 2013
Completion
Apr 2014
Results posted
Aug 19, 2016
Last update
Aug 19, 2016

Study contacts

Kyeonghee Lee, PhD
principal investigator · Yeongnam Univ. hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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