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An Interventional Study to Assess the Efficacy and Safety of Oxycodone/Naloxone in Korean Patients With Spinal Disorders

NCT01811238 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2016-05-12

Study results available
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Summary

Study Objectives:

1. Primary objective

\- To assess the pain reduction after 8 weeks treatment from baseline (week 0)
2. Secondary objectives

* To assess the pain reduction after 4 weeks treatment from baseline (week 0)
* To assess the EQ-5D
* To assess physician's overall satisfaction
* To assess subject's overall satisfaction
* To assess safety

Conditions

  • Spinal Disorders

Interventions

DRUG

Oxycodone/naloxone

Targin 5mg, 10mg, 20mg up to 40mg b.i.d

Sponsors & Collaborators

  • Mundipharma Korea Ltd

    lead INDUSTRY

Principal Investigators

  • Sung Soo Shung · Samsung Medical Center

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-04-30
Completion
2013-07-31

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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 NCT01811238 on ClinicalTrials.gov