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

NCT01675531 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2016-12-16

Study results available
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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.

Conditions

Interventions

DRUG

Targin

Single arm for Targin

Sponsors & Collaborators

  • Mundipharma Korea Ltd

    lead INDUSTRY

Principal Investigators

  • Kang, Ph.D · Seoul ST.Mary Hospital

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2013-12-31
Completion
2014-06-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01675531 on ClinicalTrials.gov