A Study to Assess the Efficacy and Safety of Oxycodone/Naloxone in Korean Patients With Chemotherapy-Induced Peripheral Neuropathy (CIPN)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Naloxone | Small molecule | 5 mg | — |
| Subject | Oxycodone | Other / unclassified | 10 mg | — |