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Randomised, Double-Blind, Double-Dummy, Parallel-Group Multicentre Study to Demonstrate Non-Inferiority in Pain and Locomotor Function and Improvement in Symptoms of Constipation in Subjects With Moderate to Severe Pain Due to Osteoarthritis (OA) of the Knee and/or Hip Taking Oxycodone Equivalent of 20 - 80 mg/Day as Oxycodone/Naloxone Prolonged Release (OXN PR) Compared to Subjects Taking Oxycodone Prolonged Release Tablets (OxyPR) Alone.

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Randomised, Double-Blind, Double-Dummy, Parallel-Group Multicentre Study to Demonstrate Non-Inferiority in Pain and Locomotor Function and Improvement in Symptoms of Constipation in Subjects With Moderate to Severe Pain Due to Osteoarthritis (OA) of the Knee and/or Hip Taking Oxycodone Equivalent of 20 - 80 mg/Day as Oxycodone/Naloxone Prolonged Release (OXN PR) Compared to Subjects Taking Oxycodone Prolonged Release Tablets (OxyPR) Alone.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 30 Oct 2018

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At a glance

  • Drugs Naloxone/oxycodone (Primary) ; Oxycodone
  • Indications Musculoskeletal pain; Osteoarthritis
  • Focus Therapeutic Use
  • Sponsors Mundipharma GmbH

    • Most Recent Events

    • 28 Apr 2012 Additional trial locations (Netherlands, Austria) identified as reported by European Clinical Trials Database.
    • 28 Apr 2012 Planned number of patients changed from 200 to 260 as reported by European Clinical Trials Database.
    • 16 Feb 2012 Actual patient number is 181 according to ClinicalTrials.gov.

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