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

Phase 4

Completed

• Conditions: Low Back Pain

• Registration Number: NCT03768466
• Lead Sponsor: Mundipharma Korea Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-20
• Study Start: 2018-11-21
• Study First Submitted QC: 2018-12-06
• Study First Posted: 2018-12-07
• Primary Completion: 2020-02-20
• Study Completion: 2020-09-17
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-21
• Last Update Posted: 2021-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change of NRS average score from week 0 to week 8	week 8	reduction of pain intensity of week 8 average NRS score

Trial Locations

Locations (2)

SMG-SNU Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of