Post Operative PainPhase 4OXN4505NCT01083485
OXN PR Compared to OXY PR in Subjects With Postoperative Pain After Knee Arthroplasty
A Phase 4 study testing Oxycodone/Naloxone PR 20/10mg or 10/5mg tablets and Oxycodone in people with Post Operative Pain, run by Mundipharma Oy at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Oxycodone/Naloxone PR 20/10mg or 10/5mg tablets and Oxycodone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2010to Nov 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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:
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Oxycodone/Naloxone PR 20/10mg or 10/5mg tablets, Oxycodone
- Keywords
- Oxycodone, Naloxone, Postoperative pain, Arthroplasty, Efficacy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxycodone/Naloxone PR 20/10mg or 10/5mg tabletsDrug
Oxycodone/Naloxone prolonged release 20/10mg or 10/5mg tabs twice a day (BID) for 2.5 days (total 5 dosages)or Oxycodone 20mg
OxycodoneDrug
Oxycodone 20mg or 10mg BID for 2.5 days (total 5 dosages)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Drug: Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Mean dose during the whole double blind treatment phase (2.5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionOct 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mundipharma Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01083485
- Sponsor's protocol ID
- OXN4505
- Other IDs
- 2009-016957-17, 2009
- Acronym
- OXN4505
- Status last verified
- Feb 2012
- First submitted
- 8 Mar 2010
- Last updated
- 16 Feb 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01083485
- Acronym / sponsor ID
- OXN4505 / OXN4505
- Conditions
- Post Operative Pain
- Keywords
- Oxycodone, Naloxone, Postoperative pain, Arthroplasty, Efficacy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Mundipharma OyIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 9 Mar 2010 (estimated)
- Results
- Posted 16 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tablets Oxycodone Naloxone (OXN) | Experimental | Drug: Oxycodone/Naloxone PR 20/10mg or 10/5mg tabletsOxycodone/Naloxone prolonged release 20/10mg or 10/5mg tabs twice a day (BID) for 2.5 days (total 5 dosages) |
| Oxycodone | Active comparator | Drug: OxycodoneOxycodone PR 20mg or 10mg (twice a day) BID for 2.5 days (total 5 dosages) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- Confirmed diagnosis of osteoarthritis of the knee.
- Planned surgical arthroplasty on one knee.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxycodone/Naloxone PR 20/10mg or 10/5mg tabletsOxycodone/Naloxone prolonged release 20/10mg or 10/5mg tabs twice a day (BID) for 2.5 days (total 5 dosages)or Oxycodone 20mg | Drug | Tablets Oxycodone Naloxone (OXN) |
| OxycodoneOxycodone 20mg or 10mg BID for 2.5 days (total 5 dosages) | Drug | Oxycodone |
Primary outcome
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)
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.
1 secondary outcome
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxycodone/Naloxone PR 20/10mg or 10/5mg tablets and Oxycodone in people with Post Operative Pain, run by Mundipharma Oy at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2012.