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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03768466

Enrollment

123

Registered

2018-12-07

Start date

2018-11-21

Completion date

2020-09-17

Last updated

2021-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

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.

Interventions

DRUGBrand Name: Targin®

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026