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

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Asan Medical Center, Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brand Name: Targin®

Drug

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

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Mundipharma Korea Ltd

Industry

Registry information

Official study 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

Important dates

Study start: 2018
Primary completion: 2020
Study completion: 2020
First posted: Dec 7, 2018
Registry last updated: Jan 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed