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

NCT ID: NCT01083485

Last Updated: 2012-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 137 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2010-11-30

Brief 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.

Conditions

Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Tablets Oxycodone Naloxone (OXN)

Oxycodone/Naloxone prolonged release 20/10mg or 10/5mg tabs twice a day (BID) for 2.5 days (total 5 dosages)

Group Type: EXPERIMENTAL

Oxycodone/Naloxone PR 20/10mg or 10/5mg tablets

Intervention Type: DRUG

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

Oxycodone PR 20mg or 10mg (twice a day) BID for 2.5 days (total 5 dosages)

Group Type: ACTIVE_COMPARATOR

Oxycodone

Intervention Type: DRUG

Oxycodone 20mg or 10mg BID for 2.5 days (total 5 dosages)

Interventions

Oxycodone/Naloxone PR 20/10mg or 10/5mg tablets

Oxycodone/Naloxone prolonged release 20/10mg or 10/5mg tabs twice a day (BID) for 2.5 days (total 5 dosages)or Oxycodone 20mg

Intervention Type: DRUG

Oxycodone

Oxycodone 20mg or 10mg BID for 2.5 days (total 5 dosages)

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mundipharma Oy

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Central hospital of Pori

Pori, , Finland

Countries

Finland

Other Identifiers

2009-016957-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

OXN4505

Identifier Type: -

Identifier Source: org_study_id