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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Cancer

Intervention / Treatment
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* Drug: Oxycodone/Naloxone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female cancer patients 20 years of age or older Cancer related pain that requires treatment with continuous around-the-clock strong opioid analgesic Moderate to severe pain intensity (NRS pain score >=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 Ability to communicate effectively with the study personnel regarding pain intensity, constipation assessment, final assessment of overall efficacy and tolerability Subject who provide signed and dated written voluntary informed consent Exclusion Criteria: Pregnant or nursing (lactating) women Have previously received treatment with Targin Patient with evidence of significant structural/functional abnormalities of GI tract which is not appropriate for oral medicine administration Any history of hypersensitivity to Oxycodone and Naloxone or any excipients Patients with significant respiratory depression Patients with acute or severe bronchial asthma or hypercarbia Any patient who has or is suspected of having paralytic ileus Severe Chronic obstructive pulmonary disease, pulmonary heart disease Targin product contains lactose. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take Patients with moderate and severe hepatic impairment 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) Any situation where opioids are contraindicated With a life expectancy < 1 month Any situation where opioids are contraindicated Mainly pain originated other than cancer or cancer related conditions (eg. Musculoskeletal pain, inflammatory pain, diabetic polyneuropathy) 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 Patients with uncontrolled seizures Requiring interventional treatment for pain such as neurodestructive procedure or regional infusion With a history of alcohol abuse within 6 months of screening With a history of illicit drug abuse within 6 months of screening Patients with increased intracranial pressure Having used other investigational drugs at the time of enrollment, or within 30 days.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxycodone/naloxone<br>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<br>* Twice daily<br>* Other names: Targin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4weeks | 
| 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) | 4 weeks | 
| 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. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Targin, Cancer Pain