A Multicenter, Phase IV, Interventional Study to Assess the Efficacy and Safety of Oxycodone/Naloxone in Korean Patients With Chemotherapy-Induced Peripheral Neuropathy Who Need Opioid Combination Treatment With Existing Pregabalin Treatment
This will be a multicenter, phase IV, interventional study to assess the efficacy and safety
of TARGIN (Oxycodone/Naloxone) Korean patients with CIPN(Chemotherapy-Induced Peripheral
Neuropathy) who need opioid combination treatment with existing pregabalin of last dose
prior to study enrollment without changing.
Upon providing written informed consent, subject will be screened in the study and
assessment will be performed at that time such as safety data(AE/SAE) including laboratory
results, physical examination, vital sign, medical history taking, 24 hours pain intensity
score, FACIT-GOG/NTX, physician's overall satisfaction and subject's overall satisfaction.
If patient is eligible in inclusion/exclusion criteria at the time of visit 1, the patient
will receive treatment with TARGIN. Re-screening, study drug dose interruption is not
allowed. The duration of study drug dose interruption is defined as for 1 week.
Treatment with TARGIN will be started at 10/5mg twice daily for 4 weeks, and proper
titration (up-titration) will be allowed at each visit according to the investigator's
decision. Dose titration up to a maximum of TARGIN 40/20mg twice daily will be permitted
during study period.
The up-titration will be considered by investigator's judgement as followings; (1) if the
rescue medication was used more than 2 times per day, on average or (2) based on the daily
average NRS, if the NRS was changed to worsen since the previous visit, (3) Investigator's
judgement by considering any titration needed situation (e.g. dose, frequency of rescue
Safety laboratories will be obtained at baseline (visit 1) and study end (visit 4) in a
local laboratory. The laboratory values within 4 weeks prior to baseline (visit 1) will be
allowed to use at study visit 1.
The rescue medication is the 5mg of IRcodonTM.
Patients will be withdrawn from the study if the following circumstance require study drug
Failure of pain control (Failure of pain control will be decided by investigators judgement,
e.g. there is poor pain control or lack of efficacy despite 2~3 times of up titration.)
Adjustment of the other analgesics due to AE except TARGIN or IRcodonTM Adjustment of the
other major pain management modality (e.g. chemotherapy, radiotherapy, surgery, non-surgical
interventional therapy, etc.) Withdrawal of informed consent Pregnancy Any other significant
risk to the patient's safety in the clinical judgement of the investigator
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
NRS(Numeric rating scale
To assess the pain reduction rate after 4 weeks treatment from baseline (week 0)
4 weeks later from baseline
Seoul ST.Mary Hospital
South Korea: Korea Food and Drug Administration (KFDA)