Efficacy and Safety of Oxycodone/Naloxone (Targin®) in Persistent Moderate to Severe Low Back Pain Following NSAIDs Treatment

January 21, 2021 updated by: Mundipharma Korea Ltd

An 8-week, Prospective, Interventional, Single-arm, Multi-centre, Phase IV Study to Evaluate the Efficacy and Safety of Controlled-release Oxycodone/Naloxone (Targin®) in Moderate to Severe Low Back Pain Patients Who Are Not Adequately Controlled by NSAIDs

The purpose of this study is to evaluate the efficacy of the study drug (Targin®) after 8 weeks of treatment in patients with moderate to severe low back pain who are uncontrolled* by NSAIDs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

123

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 07061
        • SMG-SNU Boramae Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Korean patients age ≥ 19 years old
  2. Patients having moderate to severe low back pain (NRS pain score ≥4) for ≥ 7 days and ≤ 90 days not satisfactorily controlled with NSAIDs
  3. Patients showing average NRS pain score ≥4 over the last 1 week at screening point
  4. In case of previous opioids medication history, opioids wash-out period > 30 days before enrolment
  5. Patients who is willing to voluntarily sign informed consent

Exclusion Criteria:

  1. Patients with any history of hypersensitivity to oxycodone, naloxone or related products
  2. Low back pain coming from cancer, infectious disease, psychiatric issue or congenial cause
  3. Pregnant or lactating women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brand Name: Targin®
Brand Name: Targin® Generic name: Oxycodone/Naloxone dosage form: Oral
Drug: Brand Name: Targin®
Brand Name: Targin® Generic name: Oxycodone/Naloxone dosage form: Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of NRS average score from week 0 to week 8
Time Frame: week 8
reduction of pain intensity of week 8 average NRS score
week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mundipharma Korea Ltd

Investigators

  • Principal Investigator: JaeHyup Lee, SMG-SNU Boramae Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2018

Primary Completion (Actual)

February 20, 2020

Study Completion (Actual)

September 17, 2020

Study Registration Dates

First Submitted

November 20, 2018

First Submitted That Met QC Criteria

December 6, 2018

First Posted (Actual)

December 7, 2018

Study Record Updates

Last Update Posted (Actual)

January 25, 2021

Last Update Submitted That Met QC Criteria

January 21, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OXN18-KR-401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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