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

Mundipharma Korea Ltd123 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

123

Conditions

Low Back Pain

Interventions

Brand Name: Targin®DRUG

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

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (2)

Asan Medical Center

Seoul, South Korea

SMG-SNU Boramae Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Change of NRS average score from week 0 to week 8

reduction of pain intensity of week 8 average NRS score

Time frame: week 8

Data from ClinicalTrials.gov

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