OsteoarthritisPhase 4NCT00784810

A Study to Compare Oxycodone/Naloxone Prolonged Release Against Codeine/Paracetamol in the Treatment of Moderate to Severe Chronic Low Back Pain or Pain Due to Osteoarthritis

A Phase 4 study testing Oxycodone/Naloxone and Codeine/Paracetamol in people with Osteoarthritis and Back Pain, run by Napp Pharmaceuticals Limited at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to compare oxycodone/naloxone combination tablet and codeine/paracetamol tablets in the treatment of moderate to severe chronic low back pain or pain due to osteoarthritis. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Osteoarthritis, Back Pain
What is being tested?: Oxycodone/Naloxone and Codeine/Paracetamol
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 247 participants
Where: 1 siteUnited Kingdom
Study dates: Feb 2009to Jun 2011
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female subjects at least 18 years or older.
Female subjects less than one year post-menopausal must have a negative urine pregnancy test recorded prior to the first dose of study medication, be non-lactating, and willing to use adequate and reliable contraception throughout the study. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilization, implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.
Subjects with a clinical diagnosis of degenerative or primary OA whose primary pain site is of the hip(s) and/or knee(s) and that require around-the-clock opioid therapy in which the diagnosis may be supported by evidence such as one of the following: MRI, CAT, arthroscopy or x-ray. The clinical imaging of OA may include one or more of the following features: joint space narrowing, degenerative changes, osteophyte formation or subchondral cysts. Subjects will identify the most painful joint (hip or knee) for documentation of OA. Pain measurement will be done at this joint only.
Subjects with moderate to severe chronic low back pain e.g osteoarthritis, spinal stenosis, spondylolisthesis, failed back surgery, scoliosis, discogenic disorders such as herniated disc.
Subjects who are currently receiving codeine/paracetamol combination tablets up to a maximum dose of 120 mg codeine per day or tramadol up to a maximum dose of 100 mg/day or dihydrocodeine / paracetamol tablets up to a maximum dose of 120 mg dihydrocodeine per day.
Subjects willing and able to participate in all aspects of the core study, including use of oral medication, completion of subjective evaluations, attending scheduled clinic visits, completing telephone contacts, and compliance with protocol requirements as evidenced by providing written, informed consent.
Subjects in which the pre-study, non-opioid analgesics, and all other concomitant medications, including those medications for the treatment of depression are anticipated to remain stable throughout the treatment phase of the study.

Who cannot join

Any history of hypersensitivity to oxycodone, naloxone, codeine, ibuprofen, bisacodyl or related products and ingredients.
Any contraindication to oxycodone, naloxone, codeine, paracetamol or ibuprofen.
Subjects with evidence of significant structural abnormalities of the GI tract (e.g., bowel obstruction, strictures) or any diseases/conditions that affect bowel transit (e.g., ileus, hypothyroidism).
Subjects with cancer associated pain.
Subjects with secondary osteoarthritis (e.g. fracture, septic, acromegaly etc.).
Active alcohol or drug abuse and/or history of opioid abuse.

Show all 18Show fewer

Subjects with Rheumatoid Arthritis.
Subjects with non opioid induced constipation.
Subjects with evidence of clinically unstable disease, as determined by medical history, clinical laboratory tests, ECG results, and physical examination that, in the investigator's opinion, preclude entry into the study.
Subjects with evidence of impaired liver/kidney function upon entry into the study defined as: Aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase levels >3 times the upper limit of normal; Gamma glutamyl transpeptidase ≥5 times the upper limit of normal; Total bilirubin level outside of the reference range unless the value is associated with pre documented Gilbert's Syndrome; Creatinine level outside of the reference range or > 2 mg/dl unless after discussion with the Medical Monitor it is confirmed the subject does not have renal impairment that would preclude the subject's inclusion in the study; In the investigator's opinion the subject has liver and/or kidney impairment to the extent that the subject should not participate in this study.
Subjects who have required treatment for the diagnosis of IBS.
Subjects receiving hypnotics or other CNS depressants that, in the investigator's opinion, may pose a risk of additional CNS depression with opioid study medication.
Subjects with a history of depression or other psychiatric disorder that in the opinion of the investigator is significant enough to exclude the subject from the study.
Subjects who are currently involved in legal action regarding their pain condition or subjects in which their pain condition may be of a psychiatric nature.
Subjects receiving opioid substitution therapy for opioid addiction (e.g., methadone or buprenorphine).
Subjects presently taking, or who have taken naloxone or naltrexone within 30 days of study entry (defined as the start of the Screening Period).
Surgery within 2 months prior to the start of the Screening Period, or planned surgery during the12-week treatment period that may affect GI motility or pain levels.
Subjects who have received a new chemical entity or an experimental drug within 30 days of study entry (define as the start of the Screening Period).

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Study site
Coventry, CV6 4DD

Other trials in United Kingdom

About this study

Official title: A Double-blind, Double-dummy, Parallel Group, Randomised Study to Compare the Efficacy & Tolerability of Oxycodone/Naloxone Prolonged Release (OXN PR) & Codeine/Paracetamol in the Treatment of Moderate to Severe Chronic Low Back Pain or Pain Due to Osteoarthritis

Read the detailed description

This is a randomised, double-blind, double-dummy, parallel group, 12-week study to assess the efficacy and tolerability of oxycodone/naloxone compared to codeine/paracetamol tablets in the treatment of moderate to severe chronic low back pain or moderate to severe pain due to OA of the hip and /or knee.

The screening period will be 3 - 7 days duration. If a subject meets all the screening criteria they may enter the Run-in Period.

During the screening period subjects will continue to take their pre-study pain medication.

The run-in period will be 7 - 14 days duration. During the run-in period subjects will continue to take their pre-study pain medication.

Visit 3 will occur at the end of the Run-in Period (7-14 days after Visit 2). To qualify for entry into the treatment period of the study, subjects must have uncontrolled pain as shown by average daily pain scores of >5 on 4 of the last 7 days of the run in period.

Eligible subjects will be randomised to either oxycodone/naloxone or codeine/paracetamol tablets. Subjects will receive double-blind study medication for up to 12 weeks.

Conditions: Osteoarthritis, Back Pain
Being tested: Oxycodone/Naloxone, Codeine/Paracetamol
Keywords: Efficacy, tolerability, moderate/severe, oxycodone/naloxone, codeine/paracetamol, chronic low back pain, osteoarthritis
Medical subject headings: Osteoarthritis, Back Pain, Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Oxycodone/NaloxoneDrug
5/2.5, 10/5 and 20/10 mg oxycodone/naloxone combination, 12 hourly
Codeine/ParacetamolDrug
15/500 and 30/500 mg codeine/paracetamol tablets, 2 tablets 6 hourly

Study groups in NCT00784810
Study group	Role	What they receive
Oxycodone/Naloxone Tablets	Experimental	Oxycodone/Naloxone combination Receives: Drug: Oxycodone/Naloxone
Codeine/Paracetamol Tablets	Active comparator	Codeine/Paracetamol combination Receives: Drug: Codeine/Paracetamol

What is being measured

The primary outcome is the main question the study is designed to answer.

Average Daily Pain Score Box Scale-11 (BS-11) Recorded at Week 12 (Average Pain Over Last 24 Hours)
The primary objective was to demonstrate non inferiority of Oxycodone/Naloxone Prolonged Release (OXN PR) compared to codeine/paracetamol in moderate to severe pain as assessed by BS-11 average daily pain scores. The Box Scale-11 is a scale from 0 to 10 (i.e. 0, 1, 2...10), where the subject records their daily pain over the previous 24 hours, by circling the relevant box, where 0 = no pain and 10 = pain as bad as you can imagine. This value is the value recorded at week 12 (average pain over the last 24 hours)
Measured: Average daily pain over last 24 hours (at Week 12)

Secondary outcomes (1)

Number of Intakes of Rescue Medication (Ibuprofen) Between Visit 8 and Visit 9 for the 2 Groups.
To compare the number of intakes of rescue medication use (ibuprofen) for breakthrough pain between OXN (Oxycodone/Naloxone) and codeine/paracetamol groups. Ibuprofen tablets (400mg up to 3 times per day) were available as rescue medication. This was recorded by the subject in their diary whenever it was taken. The discrepancy in numbers of patients at this stage (between Visit 8 and Visit 9) is due to subject withdrawal during the study. The mean values presented are the "number of intakes of rescue medication" for this period (ie between Visit 8 and Visit 9).
Measured: Between visit 8 and 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2009Jun 2011

First posted4 Nov 2008 (estimated)
Study startFeb 2009
Primary completionMar 2010
Study completionJun 2011

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 OsteoarthritisStudies 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: 247 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00784810
Sponsor's protocol ID: OXN4502 (2008-002426-10)
Status last verified: Sep 2011
First submitted: 3 Nov 2008
Last updated: 2 Nov 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Double-dummy, Parallel Group, Randomised Study to Compare the Efficacy & Tolerability of Oxycodone/Naloxone Prolonged Release (OXN PR) & Codeine/Paracetamol in the Treatment of Moderate to Severe Chronic Low Back Pain or Pain Due to Osteoarthritis
ClinicalTrials.gov ID: NCT00784810
Acronym / sponsor ID: OXN4502 (2008-002426-10)
Conditions: Osteoarthritis, Back Pain
Keywords: Efficacy, tolerability, moderate/severe, oxycodone/naloxone, codeine/paracetamol, chronic low back pain, osteoarthritis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 247 participants (actual)
Lead sponsor: Napp Pharmaceuticals LimitedIndustry (pharma, biotech, devices)
Study start: Feb 2009
Primary completion: Mar 2010 (actual)
Study completion: Jun 2011 (actual)
First posted: 4 Nov 2008 (estimated)
Results: Posted 2 Nov 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The screening period will be 3 - 7 days duration. If a subject meets all the screening criteria they may enter the Run-in Period.

During the screening period subjects will continue to take their pre-study pain medication.

The run-in period will be 7 - 14 days duration. During the run-in period subjects will continue to take their pre-study pain medication.

Eligible subjects will be randomised to either oxycodone/naloxone or codeine/paracetamol tablets. Subjects will receive double-blind study medication for up to 12 weeks.

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
Oxycodone/Naloxone Tablets	Experimental	Drug: Oxycodone/NaloxoneOxycodone/Naloxone combination
Codeine/Paracetamol Tablets	Active comparator	Drug: Codeine/ParacetamolCodeine/Paracetamol combination

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Male or female subjects at least 18 years or older.
Female subjects less than one year post-menopausal must have a negative urine pregnancy test recorded prior to the first dose of study medication, be non-lactating, and willing to use adequate and reliable contraception throughout the study. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilization, implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.
Subjects with a clinical diagnosis of degenerative or primary OA whose primary pain site is of the hip(s) and/or knee(s) and that require around-the-clock opioid therapy in which the diagnosis may be supported by evidence such as one of the following: MRI, CAT, arthroscopy or x-ray. The clinical imaging of OA may include one or more of the following features: joint space narrowing, degenerative changes, osteophyte formation or subchondral cysts. Subjects will identify the most painful joint (hip or knee) for documentation of OA. Pain measurement will be done at this joint only.
Subjects with moderate to severe chronic low back pain e.g osteoarthritis, spinal stenosis, spondylolisthesis, failed back surgery, scoliosis, discogenic disorders such as herniated disc.
Subjects who are currently receiving codeine/paracetamol combination tablets up to a maximum dose of 120 mg codeine per day or tramadol up to a maximum dose of 100 mg/day or dihydrocodeine / paracetamol tablets up to a maximum dose of 120 mg dihydrocodeine per day.

Key exclusion criteria (18 listed)

Any history of hypersensitivity to oxycodone, naloxone, codeine, ibuprofen, bisacodyl or related products and ingredients.
Any contraindication to oxycodone, naloxone, codeine, paracetamol or ibuprofen.
Subjects with evidence of significant structural abnormalities of the GI tract (e.g., bowel obstruction, strictures) or any diseases/conditions that affect bowel transit (e.g., ileus, hypothyroidism).
Subjects with cancer associated pain.
Subjects with secondary osteoarthritis (e.g. fracture, septic, acromegaly etc.).

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/Naloxone5/2.5, 10/5 and 20/10 mg oxycodone/naloxone combination, 12 hourly	Drug	Oxycodone/Naloxone Tablets
Codeine/Paracetamol15/500 and 30/500 mg codeine/paracetamol tablets, 2 tablets 6 hourly	Drug	Codeine/Paracetamol Tablets

Primary outcome

Average Daily Pain Score Box Scale-11 (BS-11) Recorded at Week 12 (Average Pain Over Last 24 Hours)
Time frame: Average daily pain over last 24 hours (at Week 12)
The primary objective was to demonstrate non inferiority of Oxycodone/Naloxone Prolonged Release (OXN PR) compared to codeine/paracetamol in moderate to severe pain as assessed by BS-11 average daily pain scores. The Box Scale-11 is a scale from 0 to 10 (i.e. 0, 1, 2...10), where the subject records their daily pain over the previous 24 hours, by circling the relevant box, where 0 = no pain and 10 = pain as bad as you can imagine. This value is the value recorded at week 12 (average pain over the last 24 hours)

1 secondary outcome

Number of Intakes of Rescue Medication (Ibuprofen) Between Visit 8 and Visit 9 for the 2 Groups.
Time frame: Between visit 8 and 9

Results and safety

Results posted to the registry on 2 Nov 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Oxycodone/Naloxone Tablets (OXN)	124	61
Codeine/Paracetamol Tablets	123	74

Primary outcome: Average Daily Pain Score Box Scale-11 (BS-11) Recorded at Week 12 (Average Pain Over Last 24 Hours)

Time frame: Average daily pain over last 24 hours (at Week 12). Mean (Standard Deviation). Unit: Units on a BS-11 scale at Week 12

Measure	Oxycodone/Naloxone Tablets (OXN) n = 60	Codeine/Paracetamol Tablets n = 80
Value	4.2 (2.139)	4.64 (2.046)

Oxycodone/Naloxone Tablets (OXN) vs Codeine/Paracetamol Tablets: Mean Difference (Net): 0.44, p = 0.002, Mixed Models Analysis

Population analysed: To achieve a study with 80% power at the 1-sided 5% sig level and define non-inferiority to be a relative different less than 1.2. A sample size of 98 subjects per treatment group was required, ie a total of 196 subjects completing the study. The lower number of participants is due to subject withdrawal or lack of data.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: approximately 3 - 4 months, treatment and outcome. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Oxycodone/Naloxone Tablets (OXN)	3 of 124 (2.4%)	27 of 124 (21.8%)	Not reported
Codeine/Paracetamol Tablets	4 of 123 (3.3%)	32 of 123 (26%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2011.
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 and Codeine/Paracetamol in people with Osteoarthritis and Back Pain, run by Napp Pharmaceuticals Limited at 1 site in United Kingdom.

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 7 inclusion and 18 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 2 Nov 2011. 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 United Kingdom. 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 2 Nov 2011). 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?

Average Daily Pain Score Box Scale-11 (BS-11) Recorded at Week 12 (Average Pain Over Last 24 Hours) (time frame: Average daily pain over last 24 hours (at Week 12)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00784810.

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 2 Nov 2011.