Back to resultsOXN PR Compared to OXY PR in Subjects With Postoperative Pain After Knee Arthroplasty (OXN4505)
Primary Purpose
Post Operative Pain
Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Oxycodone/Naloxone PR 20/10mg or 10/5mg tablets
Oxycodone
Sponsored by
About this trial
This is an interventional treatment trial for Post Operative Pain focused on measuring Oxycodone, Naloxone, Postoperative pain, Arthroplasty, Efficacy
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:
Sites / Locations
- Central hospital of Pori
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tablets Oxycodone Naloxone (OXN)
Oxycodone
Arm Description
Oxycodone/Naloxone prolonged release 20/10mg or 10/5mg tabs twice a day (BID) for 2.5 days (total 5 dosages)
Oxycodone PR 20mg or 10mg (twice a day) BID for 2.5 days (total 5 dosages)
Outcomes
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)
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01083485
Brief Title
OXN PR Compared to OXY PR in Subjects With Postoperative Pain After Knee Arthroplasty
Acronym
OXN4505
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mundipharma Oy
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
Oxycodone, Naloxone, Postoperative pain, Arthroplasty, Efficacy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
137 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tablets Oxycodone Naloxone (OXN)
Arm Type
Experimental
Arm Description
Oxycodone/Naloxone prolonged release 20/10mg or 10/5mg tabs twice a day (BID) for 2.5 days (total 5 dosages)
Arm Title
Oxycodone
Arm Type
Active Comparator
Arm Description
Oxycodone PR 20mg or 10mg (twice a day) BID for 2.5 days (total 5 dosages)
Intervention Type
Drug
Intervention Name(s)
Oxycodone/Naloxone PR 20/10mg or 10/5mg tablets
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
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Intervention Description
Oxycodone 20mg or 10mg BID for 2.5 days (total 5 dosages)
Primary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
Mean of 24 hour pain intensity (absolute change from baseline)
Secondary Outcome Measure Information:
Title
Mean Dose (mg) of Rescue Analgesia for the Treatment Phase for Subjects Taking 20/10mg OXN PR Tablets or 20mg OXY PR Tablets
Description
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.
Time Frame
Mean dose during the whole double blind treatment phase (2.5 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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:
Facility Information:
Facility Name
Central hospital of Pori
City
Pori
ZIP/Postal Code
28500
Country
Finland
12. IPD Sharing Statement
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OXN PR Compared to OXY PR in Subjects With Postoperative Pain After Knee Arthroplasty
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