drugset / Trial / NCT01675531

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

NCT01675531

Phase 4 Completed 73 enrolled Mundipharma Korea Ltd
NaSingle-groupOpen-labelSupportive care

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.

Timeline

Start
2012-12
Primary completion
2013-12
Completion
2014-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Naloxone Small molecule 5 mg
Subject Oxycodone Other / unclassified 10 mg

Indications