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NCT03768466 Clinical Trial

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

Low Back Pain Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03768466
Other study ID # OXN18-KR-401
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date November 21, 2018
Est. completion date September 17, 2020

Study information
Verified date January 2021
Source Mundipharma Korea Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 123
Est. completion date September 17, 2020
Est. primary completion date February 20, 2020
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Brand Name: Targin®
Brand Name: Targin® Generic name: Oxycodone/Naloxone dosage form: Oral

Locations
Country Name City State
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of SMG-SNU Boramae Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Mundipharma Korea Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change of NRS average score from week 0 to week 8 reduction of pain intensity of week 8 average NRS score week 8
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