NCT01675531

A Study to Assess the Efficacy and Safety of Oxycodone/Naloxone in Korean Patients With Chemotherapy-Induced Peripheral Neuropathy (CIPN)

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Mundipharma Korea Ltd · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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. The investigators will assess study objectives as below. Primary objective * To assess the pain reduction rate after 4 weeks treatment from baseline (week 0) Secondary objectives * To assess the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACIT-GOG/NTX) * To assess physician's overall satisfaction * To assess subject's overall satisfaction * To assess safety The investigators have a hypothesis that Targin will show favorable efficacy \& safety profile for CIPN patients.

Detailed description

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 (adverse event (AE)/serious adverse events (SAEs)) including laboratory results, physical examination, vital sign, medical history taking, 24 hours pain intensity score, Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT-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 Numeric Rating Scale (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 medication). 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 (Immediate release codon trade mark)IRcodonTM . Patients will be withdrawn from the study if the following circumstance require study drug discontinuation: 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 AEs 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

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	Targin	Single arm for Targin

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-12-01
• Completion: 2014-06-01
• First posted: 2012-08-30
• Last updated: 2016-12-16
• Results posted: 2016-12-16

Locations

1 site across 1 country: South Korea