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

NCT01083485 | Completed Phase 4 Results

• 2 other identifiers: OXN45052009-016957-17
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

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

Keywords

Oxycodone; Naloxone; Postoperative pain; Arthroplasty; Efficacy

Outcome Measures

Primary Outcomes (1)

• 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)

  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.

  Mean of 24 hour pain intensity (absolute change from baseline)

Secondary Outcomes (1)

• Mean Dose (mg) of Rescue Analgesia for the Treatment Phase for Subjects Taking 20/10mg OXN PR Tablets or 20mg OXY PR Tablets

  Mean dose during the whole double blind treatment phase (2.5 days)

Study Arms (2)

Tablets Oxycodone Naloxone (OXN)

EXPERIMENTAL

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

ACTIVE COMPARATOR

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

Drug: Oxycodone

Interventions

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

Tablets Oxycodone Naloxone (OXN)

Oxycodone DRUG

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

Oxycodone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mundipharma Oy: lead

Study Sites (1)

Central hospital of Pori

Pori, 28500, Finland

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Maggie Wilson
• Organization: Mundipharma Research

+ 4401223 424444

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2010
• First Posted: March 9, 2010
• Study Start: March 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: November 1, 2010
• Last Updated: February 16, 2012
• Results First Posted: February 16, 2012

Record last verified: 2012-02

Locations

FI (1)