Overview

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

Status:
Completed

Trial end date:
2014-06-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 4

Details

Lead Sponsor:

Mundipharma Korea Ltd

Treatments:

Naloxone
Oxycodone