Status:
COMPLETED
Efficacy and Safety of Oxycodone/Naloxone (Targin®) in Persistent Moderate to Severe Low Back Pain Following NSAIDs Treatment
Lead Sponsor:
Mundipharma Korea Ltd
Conditions:
Low Back Pain
Eligibility:
All Genders
19+ years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- Korean patients age ≥ 19 years old
- Patients having moderate to severe low back pain (NRS pain score ≥4) for ≥ 7 days and ≤ 90 days not satisfactorily controlled with NSAIDs
- Patients showing average NRS pain score ≥4 over the last 1 week at screening point
- In case of previous opioids medication history, opioids wash-out period \> 30 days before enrolment
- Patients who is willing to voluntarily sign informed consent
Exclusion
- Patients with any history of hypersensitivity to oxycodone, naloxone or related products
- Low back pain coming from cancer, infectious disease, psychiatric issue or congenial cause
- Pregnant or lactating women
Key Trial Info
Start Date :
November 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 17 2020
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT03768466
Start Date
November 21 2018
End Date
September 17 2020
Last Update
January 25 2021
Active Locations (2)
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1
Asan Medical Center
Seoul, South Korea, 05505
2
SMG-SNU Boramae Medical Center
Seoul, South Korea, 07061