NCT03768466

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
123

participants targeted

Target at P50-P75 for phase_4 low-back-pain

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

November 20, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

November 21, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 7, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2020

Completed
Last Updated

January 25, 2021

Status Verified

January 1, 2021

Enrollment Period

1.2 years

First QC Date

November 20, 2018

Last Update Submit

January 21, 2021

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • Change of NRS average score from week 0 to week 8

    reduction of pain intensity of week 8 average NRS score

    week 8

Study Arms (1)

Brand Name: Targin®

EXPERIMENTAL

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

Drug: Brand Name: Targin®

Interventions

Brand Name: Targin®DRUG

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

Brand Name: Targin®

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Asan Medical Center

Seoul, 05505, South Korea

Location

SMG-SNU Boramae Medical Center

Seoul, 07061, South Korea

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • JaeHyup Lee

    SMG-SNU Boramae Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2018

First Posted

December 7, 2018

Study Start

November 21, 2018

Primary Completion

February 20, 2020

Study Completion

September 17, 2020

Last Updated

January 25, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(2)