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

• Status: Completed
• Trial end date: 2020-09-17
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mundipharma Korea Ltd
• Treatments: Naloxone; Oxycodone

Criteria

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