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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01719757
Recruitment Status : Completed
First Posted : November 1, 2012
Results First Posted : August 19, 2016
Last Update Posted : August 19, 2016
Information provided by (Responsible Party):
Mundipharma Korea Ltd

Brief 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.

Condition or disease Intervention/treatment Phase
Cancer Drug: Oxycodone/Naloxone Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 359 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 4-week, Open Label, Multi-center, Prospective, Single-arm, Non-interventional Phase IV Study to Evaluate the Efficacy of Targin for the Treatment of Korean Patients With Cancer Pain Under Conditions of Daily Practice
Study Start Date : July 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
Twice daily
Other Name: Targin

Primary Outcome Measures :
  1. Change in Numeric Rating Scales (NRS) Score [ Time Frame: 4 weeks ]
    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).

Secondary Outcome Measures :
  1. Change of Eastern Cooperative Oncology Group(ECOG) Performance Status [ Time Frame: 4weeks ]

    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.

  2. Change of Constipation Assessment From Baseline to Visit 2(End Visit) [ Time Frame: 4 weeks ]
    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)

  3. Overall Satisfaction Assessment About Efficacy and Tolerability of Oxycodone/Naloxone by the Investigator and Subject [ Time Frame: 4 weeks ]
    The overall satisfactions by investigators & subjects were assessed 5 steps such as Very good, Good, Satisfactory, Bad, Very bad.

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01719757

Korea, Republic of
13 sites including Yeungnam University Medical Center
Daegu, Korea, Republic of, 705-717
Sponsors and Collaborators
Mundipharma Korea Ltd
Principal Investigator: Kyeonghee Lee, PhD Yeongnam Univ. hospital

Responsible Party: Mundipharma Korea Ltd Identifier: NCT01719757     History of Changes
Other Study ID Numbers: OXN11-KR-404
First Posted: November 1, 2012    Key Record Dates
Results First Posted: August 19, 2016
Last Update Posted: August 19, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mundipharma Korea Ltd:
Targin, Cancer Pain

Additional relevant MeSH terms:
Cancer Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists