PROspective Non-interventional Open laBEl Trial for TARGIN in Korean Patients With Cancer Pain (PROBE)
|ClinicalTrials.gov Identifier: NCT01719757|
Recruitment Status : Completed
First Posted : November 1, 2012
Results First Posted : August 19, 2016
Last Update Posted : August 19, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Drug: Oxycodone/Naloxone||Phase 4|
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)|
|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|
|Primary Completion Date :||October 2013|
|Study Completion Date :||April 2014|
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
Other Name: Targin
- 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).
- 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.
- 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)
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01719757
|Korea, Republic of|
|13 sites including Yeungnam University Medical Center|
|Daegu, Korea, Republic of, 705-717|
|Principal Investigator:||Kyeonghee Lee, PhD||Yeongnam Univ. hospital|