OXN PR Compared to OXY PR in Subjects With Postoperative Pain After Knee Arthroplasty (OXN4505)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mundipharma Oy
ClinicalTrials.gov Identifier:
NCT01083485
First received: March 8, 2010
Last updated: February 15, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Post Operative Pain
Drug: Oxycodone/Naloxone PR 20/10mg or 10/5mg tablets
Drug: Oxycodone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Parallel Group Multicentre Study to Demonstrate Non-inferiority of the Analgesic Efficacy of Oxycodone/Naloxone 10/5 or 20/10 mg Prolonged Release Tablets (OXN PR) BID Compared to Oxycodone 10 or 20 mg Prolonged Release Tablets (OXY PR) BID in Subjects With Postoperative Pain After Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by Mundipharma Oy:

Primary Outcome Measures:
  • Mean of 4 NRS Scores for 24 Hour Pain Intensity at Rest, Shown as Absolute Change From Baseline (i.e. a Decrease From the Baseline Value) [ Time Frame: Mean of 24 hour pain intensity (absolute change from baseline) ] [ Designated as safety issue: No ]
    The primary efficacy variable was the 24hr pain intensity score at rest, on a Numerical Rating Scale (NRS), with "0" = "no pain" and "10" = "worst possible pain". This was assessed 1 hour after dosing on Day 1 (evening only), Day 2(morning and evening) and Day 3 (morning only). The primary efficacy end point (absolute change from baseline) was analysed on the per protocol (PP) data. The mean of these scores is shown as a value that is a mean change (a decrease in pain score) from the baseline value.


Secondary Outcome Measures:
  • Mean Dose (mg) of Rescue Analgesia for the Treatment Phase for Subjects Taking 20/10mg OXN PR Tablets or 20mg OXY PR Tablets [ Time Frame: Mean dose during the whole double blind treatment phase (2.5 days) ] [ Designated as safety issue: No ]
    To compare the use of rescue analgesia for the 2 groups (OXN 20/10mg tablets and OXY 20mg tablets) during the double blind treatment phase. Rescue medication was given (OXY Immediate Release, 5mg capsules) if the subjects pain score on the (Numeric Rating Scale (NRS), 0 (no pain) to 10 (worst possible pain)), was greater than or equal to 4. The value presented is the mean dose over the double blind phase.


Enrollment: 137
Study Start Date: March 2010
Study Completion Date: November 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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)
Drug: 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
Active Comparator: Oxycodone
Oxycodone PR 20mg or 10mg (twice a day) BID for 2.5 days (total 5 dosages)
Drug: Oxycodone
Oxycodone 20mg or 10mg BID for 2.5 days (total 5 dosages)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01083485

Locations
Finland
Central hospital of Pori
Pori, Finland, 28500
Sponsors and Collaborators
Mundipharma Oy
  More Information

No publications provided

Responsible Party: Mundipharma Oy
ClinicalTrials.gov Identifier: NCT01083485     History of Changes
Other Study ID Numbers: OXN4505, 2009-016957-17
Study First Received: March 8, 2010
Results First Received: June 10, 2011
Last Updated: February 15, 2012
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Mundipharma Oy:
Oxycodone
Naloxone
Postoperative pain
Arthroplasty
Efficacy

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Oxycodone
Naloxone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotic Antagonists

ClinicalTrials.gov processed this record on September 22, 2014