Back to resultsPROspective Non-interventional Open laBEl Trial for TARGIN in Korean Patients With Cancer Pain (PROBE)
Primary Purpose
Cancer
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Oxycodone/Naloxone
Sponsored by
About this trial
This is an interventional treatment trial for Cancer focused on measuring Targin, Cancer Pain
Eligibility Criteria
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.
Sites / Locations
- 13 sites including Yeungnam University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Oxycodone/naloxone
Arm Description
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
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
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)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01719757
Brief Title
PROspective Non-interventional Open laBEl Trial for TARGIN in Korean Patients With Cancer Pain
Acronym
PROBE
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 Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mundipharma Korea Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer
Keywords
Targin, Cancer Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
359 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxycodone/naloxone
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Oxycodone/Naloxone
Other Intervention Name(s)
Targin
Intervention Description
Twice daily
Primary Outcome Measure Information:
Title
Change in Numeric Rating Scales (NRS) Score
Description
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 Outcome Measure Information:
Title
Change of Eastern Cooperative Oncology Group(ECOG) Performance Status
Description
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
Title
Change of Constipation Assessment From Baseline to Visit 2(End Visit)
Description
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
Title
Overall Satisfaction Assessment About Efficacy and Tolerability of Oxycodone/Naloxone by the Investigator and Subject
Description
The overall satisfactions by investigators & subjects were assessed 5 steps such as Very good, Good, Satisfactory, Bad, Very bad.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyeonghee Lee, PhD
Organizational Affiliation
Yeongnam Univ. hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
13 sites including Yeungnam University Medical Center
City
Daegu
ZIP/Postal Code
705-717
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
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PROspective Non-interventional Open laBEl Trial for TARGIN in Korean Patients With Cancer Pain
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