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

Last updated: January 21, 2021
Sponsor: Mundipharma Korea Ltd
Overall Status: Completed

Phase

4

Condition

Chronic Pain

Treatment

N/A

Clinical Study ID

NCT03768466
OXN18-KR-401
  • Ages > 19
  • All Genders

Study 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

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 daysbefore enrolment
  5. Patients who is willing to voluntarily sign informed consent

Exclusion

Exclusion Criteria:

  1. Patients with any history of hypersensitivity to oxycodone, naloxone or relatedproducts
  2. Low back pain coming from cancer, infectious disease, psychiatric issue or congenialcause
  3. Pregnant or lactating women

Study Design

Total Participants: 123
Study Start date:
November 21, 2018
Estimated Completion Date:
September 17, 2020

Connect with a study center

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • SMG-SNU Boramae Medical Center

    Seoul, 07061
    Korea, Republic of

    Site Not Available

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