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

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

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Drug: Oxycodone/Naloxone

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
• Enrollment (Actual): 359
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Targin

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mundipharma Korea Ltd
• Investigators: Principal Investigator: Kyeonghee Lee, PhD, Yeongnam Univ. hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: October 8, 2012
• First Submitted That Met QC Criteria: October 30, 2012
• First Posted (Estimate): November 1, 2012

Study Record Updates

• Last Update Posted (Estimate): August 19, 2016
• Last Update Submitted That Met QC Criteria: July 11, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Targin, Cancer Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Cancer Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Naloxone; Oxycodone
• Other Study ID Numbers: OXN11-KR-404

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No