OXN PR Compared to OXY PR in Subjects With Postoperative Pain After Knee Arthroplasty
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Intervention: Oxycodone/Naloxone PR 20/10mg or 10/5mg tablets; Oxycodone
Intervention description: Oxycodone/Naloxone prolonged release 20/10mg or 10/5mg tabs twice a day (BID) for 2.5 days (total 5 dosages)or Oxycodone 20mg; Oxycodone 20mg or 10mg BID for 2.5 days (total 5 dosages)
Intervention MeSH terms: Oxycodone; Naloxone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 137.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Oxycodone; Naloxone; Postoperative pain; Arthroplasty; Efficacy

Summary:

      The purpose of this study is to demonstrate that treatment with OXN PR tablets is non
      inferior to treatment with OXY PR tablets in terms of analgesic efficacy in patients with
      postoperative pain after knee arthroplasty based on average pain intensity scores.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females 18 - 75 years of age.

          -  Body mass index (BMI) 18 - 35 kg/m2.

          -  If female and less than one year post-menopausal:

               -  negative serum or urine pregnancy test (positive beta-human chorionic
                  gonadotrophin test) at screening.

               -  using an adequate and highly effective method of contraception throughout the
                  study. A highly effective method of contraception is defined as one with a
                  failure rate of less than 1% per year when used consistently and correctly.
                  Examples include sterilisation, implants, injectables, combined oral
                  contraceptives, hormonal intra uterine devices, sexual abstinence or vasectomised
                  partner.

          -  Confirmed diagnosis of osteoarthritis of the knee.

          -  Planned surgical arthroplasty on one knee.

          -  Planned postoperative epidural analgesia for approximately 48 hours.

          -  Anticipated requirement for daily opioid treatment after epidural analgesia for 2.5
             days.

          -  Able to participate in the study and have given written informed consent.

        Exclusion Criteria:

          -  Females who are pregnant or lactating.

          -  Opioid use within 3 months before the start of the screening period. Stable treatment
             with analgesics in World Health Organisation (WHO) Step I (non-opioid analgesics) is
             allowed.

          -  History of laxative use to treat constipation within 3 months before the start of the
             screening period.

          -  History of chronic constipation.

          -  Concurrent rheumatoid arthritis.

          -  Planned bilateral arthroplasty or revision knee arthroplasty.

          -  History of moderate to severe hepatic impairment.

          -  History of moderate to severe respiratory depression with hypoxia or hypercapnia,
             chronic obstructive pulmonary disease, cor pulmonale, bronchial asthma, or any severe
             impairment of pulmonary function.

          -  History of uncontrolled hypothyroidism, Addison's disease (adrenal cortical
             insufficiency), psychosis, cholelithiasis, prostatic hypertrophy(with documented
             residual of over 100 ml after voiding), delirium tremens, pancreatitis, hypotension,
             uncontrolled hypertension, uncontrolled cardiovascular diseases, head injury,
             epileptic disorder or predisposition to convulsions, or treatment with monoamine
             oxidase inhibitors (concurrent or within 2 weeks of discontinuation).

          -  Contraindication to treatment with opioids.

          -  History of hypersensitivity to oxycodone, naloxone, or to any of the excipients of OXN
             PR tablets.

          -  History of non-opioid induced paralytic ileus.

          -  Previous or current history of drug abuse, including alcohol abuse or opioid abuse.

          -  Evidence of clinically unstable disease

          -  Receipt of an investigational medicinal product within 30 days before the start of the
             screening period.

          -  Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

          -  Delayed gastric emptying.

          -  Severe renal impairment (i.e. creatinine clearance <10 mL/minute).

          -  Weight <50 kg.Inclusion Criteria: