Efficacy and Safety of Oxycodone/Naloxone (Targin®) in Pe... | NCT03768466

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

NCT03768466

Sponsor

Mundipharma Korea Ltd

Status

Completed

Last Update Posted

Jan 25, 2021Actual

Enrollment

123Actual

Phase

Phase 4

Conditions

Low Back Pain

Interventions

Brand Name: Targin®

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 21, 2018Actual

Primary Completion Date

Feb 20, 2020Actual

Completion Date

Sep 17, 2020Actual

First Submitted Date

Nov 20, 2018

First Submission Date that Met QC Criteria

Dec 6, 2018

First Posted Date

Dec 7, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 21, 2021

Last Update Posted Date

Jan 25, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

123Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Brand Name: Targin®	Experimental	Brand Name: Targin® Generic name: Oxycodone/Naloxone dosage form: Oral	Drug: Brand Name: Targin®

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Brand Name: Targin®	Drug	Brand Name: Targin® Generic name: Oxycodone/Naloxone dosage form: Oral	Brand Name: Targin®

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
JaeHyup Lee	SMG-SNU Boramae Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asan Medical Center		Seoul		05505	South Korea
SMG-SNU Boramae Medical Center

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Mar 23, 2022
Unrelease	Mar 25, 2022
Release	Mar 31, 2022
Reset	Aug 19, 2022

Submission Tracking

Estimated Results First Submitted Date

Mar 23, 2022

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Mar 23, 2022	Mar 25, 2022
Mar 31, 2022

Condition Browse Module

MeSH Terms

ID	Term
D017116	Low Back Pain

Ancestor Terms

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided