NCT03768466CompletedPhase 4
An 8-week, Prospective, Interventional, Single-arm, Multi-centre, Phase IV Study to Evaluate the Efficacy and Safety of Controlled-release Oxycodone/Naloxone (Targin®) in Moderate to Severe Low Back Pain Patients Who Are Not Adequately Controlled by NSAIDs
Mundipharma Korea Ltd2 sites in 1 country123 target enrollmentStarted: November 21, 2018Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Mundipharma Korea Ltd
- Enrollment
- 123
- Locations
- 2
- Primary Endpoint
- Change of NRS average score from week 0 to week 8
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Brand Name: Targin®
Experimental
Brand Name: Targin® Generic name: Oxycodone/Naloxone dosage form: Oral
Intervention: Brand Name: Targin® (Drug)
Outcomes
Primary Outcomes
Change of NRS average score from week 0 to week 8
Time Frame: week 8
reduction of pain intensity of week 8 average NRS score
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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