PROspective Non-interventional Open laBEl Trial for Assessment in Routine Practice of the Efficacy and the Safety of TARGIN ® in Korean Patients With Cancer Pain (PROBE)
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 Design:||Time Perspective: Prospective|
|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|
- Change in numeric rating scales (NRS) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]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)
- Quality of life [ Time Frame: 4weeks ] [ Designated as safety issue: Yes ]Change in ECOG (Eastern Cooperative Oncology Group Performance at the time of the interview) from baseline (visit 1) to study end (visit 2)
- Constipation assessment [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]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 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]Final assessment of overall efficacy and tolerability by physician and patient
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Trade name is Targin. Oxycodone (10mg)/naloxone (5mg) or Oxycodone (20mg)/naloxone (10mg) tablets provided in 56-tablet box. Twice daily per oral. Dose adjustment and asymmetric dose are allowed up to 80/40mg per day
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01719757
|Contact: Yang Haeyoung, CRAemail@example.com|
|Contact: Shin Ashley, CRMfirstname.lastname@example.org|
|Korea, Republic of|
|Yeungnam University Medical Center||Recruiting|
|Daegu, Korea, Republic of, 705-717|
|Contact: Lee KyungHee, Ph.D 82 53 620 3845|
|Principal Investigator: Yun HwanJung, Ph.D|
|Principal Investigator: Song HongSuk, Ph.D|