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

Phase 4

Completed

Conditions: Cancer

Interventions: Drug: Oxycodone/Naloxone

Registration Number: NCT01719757

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 359

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oxycodone/naloxone	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

Primary Outcome Measures

Name	Time	Method
Change in Numeric Rating Scales (NRS) Score	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

Name	Time	Method
Change of Eastern Cooperative Oncology Group(ECOG) Performance Status	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.
Change of Constipation Assessment From Baseline to Visit 2(End Visit)	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)
Overall Satisfaction Assessment About Efficacy and Tolerability of Oxycodone/Naloxone by the Investigator and Subject	4 weeks	The overall satisfactions by investigators \& subjects were assessed 5 steps such as Very good, Good, Satisfactory, Bad, Very bad.