OXN PR Compared to OXY PR in Subjects With Postoperative Pain After Knee Arthroplasty
OXN PR Compared to OXY PR in Subjects With Postoperative Pain After Knee Arthroplasty
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.
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: