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

Mundipharma

Status and phase: Completed; Phase 4

Conditions: Low Back Pain

Treatments: Drug: Brand Name: Targin®

Study type: Interventional

Funder types: Industry

Identifiers

NCT03768466

OXN18-KR-401

Details and patient eligibility

About

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.

Enrollment: 123 patients

Sex: All

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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123 participants in 1 patient group

Brand Name: Targin®

Experimental group

Description:

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

Treatment:

Drug: Brand Name: Targin®