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

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ClinicalTrials.gov Identifier: NCT03768466
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : December 18, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Low Back Pain Drug: Brand Name: Targin® Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 123 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : November 21, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Brand Name: Targin®
Brand Name: Targin® Generic name: Oxycodone/Naloxone dosage form: Oral
Drug: Brand Name: Targin®
Brand Name: Targin® Generic name: Oxycodone/Naloxone dosage form: Oral




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03768466


Contacts
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Contact: Haeri hwang, CPL 82-2-6450-9325 haeri.hwang@mundipharma.co.kr

Locations
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Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Contact: Chang-Ju Hwang         
SMG-SNU Boramae Medical Center Active, not recruiting
Seoul, Korea, Republic of, 07061
Sponsors and Collaborators
Mundipharma Korea Ltd
Investigators
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Principal Investigator: JaeHyup Lee SMG-SNU Boramae Medical Center

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Responsible Party: Mundipharma Korea Ltd
ClinicalTrials.gov Identifier: NCT03768466     History of Changes
Other Study ID Numbers: OXN18-KR-401
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Oxycodone
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Naloxone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists