NCT01811186

Brief Summary

Objectives:

  • To assess the drop-out rate caused by adverse event\* after 1 week treatment
  • To assess the pain reduction rate after 6 weeks treatment from baseline
  • To assess the Euroquol (EQ-5D) quality of life
  • To assess physician's overall satisfaction
  • To assess subject's overall satisfaction
  • To assess safety

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
261

participants targeted

Target at P75+ for phase_4 chronic-pain

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 14, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

March 10, 2017

Completed
Last Updated

March 10, 2017

Status Verified

January 1, 2017

Enrollment Period

1.1 years

First QC Date

March 12, 2013

Results QC Date

May 31, 2016

Last Update Submit

January 19, 2017

Conditions

Chronic Pain

Keywords

moderate to severe non-malignant chronic pain

Outcome Measures

Primary Outcomes (1)

  • Drop-out Rate Caused by Adverse Event After 6 Weeks Treatment

    To assess the drop-out rate caused by adverse event\* after 6 weeks treatment

    6 weeks

Secondary Outcomes (5)

  • The Drop-out Rate Due to an Adverse Event After 1 Week Treatment With the Study Drug.

    1 week

  • The Change of Pain Intensity Scores(NRS) From Baseline After 6 Weeks Treatment With the Study.

    6 weeks

  • Change of Quality of Life (EQ-5D) Score After 6 Weeks Treatment With the Study Drug

    6 weeks

  • Assessment of Investigator's Overall Satisfaction After 6 Weeks Treatment With the Study Drug

    6 weeks

  • Assessment of Subject's Overall Satisfaction After 6 Weeks Treatment With the Study Drug

    6weeks

Study Arms (2)

Group A

OTHER

Start oxycodone/naloxone 10/5mg b.i.d. titration-\>20/10mg b.i.d.-\>30/15mg b.i.d-\>40/20mg b.i.d.

Drug: Oxycodone/naloxone

Group B

OTHER

Start oxycodone/naloxone 5/2.5mg b.i.d titration-\> 10/5mg b.i.d.-\>20/10mg b.i.d.-\>30/15mg b.i.d-\>40/20mg b.i.d.

Drug: Oxycodone/naloxone

Interventions

Oxycodone/naloxoneDRUG

Oxycodone/naloxone titration

Also known as: Targin
Group AGroup B

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female ≥ 20 and \<80 years of age
  • Patients who have non-malignant chronic pain(≥90 days)
  • Patients who have moderate to severe pain intensity which is not controlled with non-strong opioid
  • Naïve patients for Oxycodone/Naloxone (Naïve patient defined as who did not treated for 90 days)
  • Naïve patients for strong opioid (Naïve patient defined as who did not treated for 90 days)
  • Patients who signed a written informed consent form

You may not qualify if:

  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
  • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine pregnancy test
  • Patients with known hypersensitivity to Oxycodone/Naloxone or to any of the excipients
  • Patient who needs acute dose titration or whose pain intensity fluctuate significantly in a short period according to investigator's judgment
  • Having used other investigational drugs at the time of enrollment, or within 30 days of enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AMC

Seoul, South Korea

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

OxycodoneNaloxone

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Results Point of Contact

Title
Hoseong Lee
Organization
Asan Medical Center
hosng@amc.seoul.kr
82-2-3010-3521

Study Officials

  • Hoseong Lee, Dr.

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2013

First Posted

March 14, 2013

Study Start

December 1, 2012

Primary Completion

January 1, 2014

Study Completion

June 1, 2014

Last Updated

March 10, 2017

Results First Posted

March 10, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)