search
Back to results

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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Brand Name: Targin®
Sponsored by
Mundipharma Korea Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Low Back Pain

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Asan Medical Center
  • SMG-SNU Boramae Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Brand Name: Targin®

Arm Description

Brand Name: Targin® Generic name: Oxycodone/Naloxone dosage form: Oral

Outcomes

Primary Outcome Measures

Change of NRS average score from week 0 to week 8
reduction of pain intensity of week 8 average NRS score

Secondary Outcome Measures

Full Information

First Posted
November 20, 2018
Last Updated
January 21, 2021
Sponsor
Mundipharma Korea Ltd
search

1. Study Identification

Unique Protocol Identification Number
NCT03768466
Brief Title
Efficacy and Safety of Oxycodone/Naloxone (Targin®) in Persistent Moderate to Severe Low Back Pain Following NSAIDs Treatment
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 21, 2018 (Actual)
Primary Completion Date
February 20, 2020 (Actual)
Study Completion Date
September 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mundipharma Korea Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
123 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brand Name: Targin®
Arm Type
Experimental
Arm Description
Brand Name: Targin® Generic name: Oxycodone/Naloxone dosage form: Oral
Intervention Type
Drug
Intervention Name(s)
Brand Name: Targin®
Intervention Description
Brand Name: Targin® Generic name: Oxycodone/Naloxone dosage form: Oral
Primary Outcome Measure Information:
Title
Change of NRS average score from week 0 to week 8
Description
reduction of pain intensity of week 8 average NRS score
Time Frame
week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Korean patients age ≥ 19 years old Patients having moderate to severe low back pain (NRS pain score ≥4) for ≥ 7 days and ≤ 90 days not satisfactorily controlled with NSAIDs Patients showing average NRS pain score ≥4 over the last 1 week at screening point In case of previous opioids medication history, opioids wash-out period > 30 days before enrolment Patients who is willing to voluntarily sign informed consent Exclusion Criteria: Patients with any history of hypersensitivity to oxycodone, naloxone or related products Low back pain coming from cancer, infectious disease, psychiatric issue or congenial cause Pregnant or lactating women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JaeHyup Lee
Organizational Affiliation
SMG-SNU Boramae Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
SMG-SNU Boramae Medical Center
City
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs