Overview

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