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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 : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Mundipharma Korea Ltd

Tracking Information
First Submitted Date  ICMJE November 20, 2018
First Posted Date  ICMJE December 7, 2018
Last Update Posted Date April 24, 2019
Actual Study Start Date  ICMJE November 21, 2018
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: December 6, 2018)
Change of average pain(NRS score) from week 0 to week 8 [ Time Frame: week 8 ]
reduction of pain intensity of week 8 average pain (NRS score)
Change History Complete list of historical versions of study NCT03768466 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Oxycodone/Naloxone (Targin®) in Persistent Moderate to Severe Low Back Pain Following NSAIDs Treatment
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Low Back Pain
Intervention  ICMJE Drug: Brand Name: Targin®
Brand Name: Targin® Generic name: Oxycodone/Naloxone dosage form: Oral
Study Arms  ICMJE Experimental: Brand Name: Targin®
Brand Name: Targin® Generic name: Oxycodone/Naloxone dosage form: Oral
Intervention: Drug: Brand Name: Targin®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 6, 2018)
123
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Haeri hwang, CPL 82-2-6450-9325 haeri.hwang@mundipharma.co.kr
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03768466
Other Study ID Numbers  ICMJE OXN18-KR-401
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mundipharma Korea Ltd
Study Sponsor  ICMJE Mundipharma Korea Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: JaeHyup Lee SMG-SNU Boramae Medical Center
PRS Account Mundipharma Korea Ltd
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP