OsteoarthritisPhase 4NCT00324038
Buprenorphine in the Treatment of Osteoarthritis (OA) in the Elderly
A Phase 4 study testing Buprenorphine and Codeine paracetamol in people with Osteoarthritis, run by Napp Pharmaceuticals Limited at 1 site in United Kingdom.
Trial summary
The primary objective is to compare buprenorphine transdermal delivery system (BTDS) with standard- treatment in subjects with osteoarthritis (OA). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Buprenorphine and Codeine paracetamol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2006to Dec 2007
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Either sex aged 65 or above
- Diagnosis of OA of the hip and/or knee
- Severe pain requiring step two medication
- Taking maximum dose of paracetamol
Who cannot join
- Painful disease of the joints other than OA
- Contraindication to buprenorphine, other opioids, patch adhesives or nonsteroidal anti-inflammatory agents (NSAIDS)
- Subjects taking cyclooxygenase (COX) II selective inhibitors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open, Randomised, Multicentre Study to Compare Buprenorphine Transdermal Delivery System (BTDS) With Standard Treatment in Elderly Subjects With OA of the Hip and/or Knee
The primary objective is to compare buprenorphine transdermal delivery system (BTDS) with standard- treatment in subjects with osteoarthritis (OA).
- Conditions
- Osteoarthritis
- Being tested
- Buprenorphine, Codeine paracetamol
- Keywords
- OA, Elderly, Pain, OA of the hips and/or knees
- Medical subject headings
- Osteoarthritis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuprenorphineDrug
Also called BuTrans/Norspan
buprenorphine transdermal system 5, 10 and 20 mg
Codeine paracetamolDrug
Also called Co-codamol tablets
combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500
| Study group | Role | What they receive |
|---|---|---|
| buprenorphine transdermal system | Experimental | Buprenorphine transdermal 7 day analgesic patch Receives: Drug: Buprenorphine |
| codeine paracetamol tablets | Active comparator | codeine paracetamol combination tablets Receives: Drug: Codeine paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Daily Pain Scores - BS11 Pain Scores.
The primary efficacy variable was the average daily pain score recorded on a Box Scale-11 pain scale in the evening. 0 = no pain and 10 = most pain imaginable. Subjects ticked the box from 0 - 10 which best describes their level of pain.
Measured: every day over a 12 week study duration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2006 (estimated)
- Study startMar 2006
- Study completionDec 2007
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Napp Pharmaceuticals Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Prof Philip Conaghan, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00324038
- Sponsor's protocol ID
- 2005-004279-39
- Other IDs
- BUP4004, 2005
- Status last verified
- Jun 2011
- First submitted
- 9 May 2006
- Last updated
- 14 Jun 2011
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Conaghan PG, O'Brien CM, Wilson M, Schofield JP. Transdermal buprenorphine plus oral paracetamol vs an oral codeine-paracetamol combination for osteoarthritis of hip and/or knee: a randomised trial. Osteoarthritis Cartilage. 2011 Aug;19(8):930-8. doi: 10.1016/j.joca.2011.03.011. Epub 2011 Apr 6.
PubMed 21477658
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Randomised, Multicentre Study to Compare Buprenorphine Transdermal Delivery System (BTDS) With Standard Treatment in Elderly Subjects With OA of the Hip and/or Knee
- ClinicalTrials.gov ID
- NCT00324038
- Acronym / sponsor ID
- 2005-004279-39
- Conditions
- Osteoarthritis
- Keywords
- OA, Elderly, Pain, OA of the hips and/or knees
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Napp Pharmaceuticals LimitedIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Study completion
- Dec 2007 (actual)
- First posted
- 10 May 2006 (estimated)
- Results
- Posted 30 Mar 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to compare buprenorphine transdermal delivery system (BTDS) with standard- treatment in subjects with osteoarthritis (OA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| buprenorphine transdermal system | Experimental | Drug: BuprenorphineBuprenorphine transdermal 7 day analgesic patch |
| codeine paracetamol tablets | Active comparator | Drug: Codeine paracetamolcodeine paracetamol combination tablets |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Either sex aged 65 or above
- Diagnosis of OA of the hip and/or knee
- Severe pain requiring step two medication
- Taking maximum dose of paracetamol
Key exclusion criteria (3 listed)
- Painful disease of the joints other than OA
- Contraindication to buprenorphine, other opioids, patch adhesives or nonsteroidal anti-inflammatory agents (NSAIDS)
- Subjects taking cyclooxygenase (COX) II selective inhibitors
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 |
|---|---|---|
| BuprenorphineAlso: BuTrans/Norspanbuprenorphine transdermal system 5, 10 and 20 mg | Drug | buprenorphine transdermal system |
| Codeine paracetamolAlso: Co-codamol tabletscombination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500 | Drug | codeine paracetamol tablets |
Primary outcome
Average Daily Pain Scores - BS11 Pain Scores.
Time frame: every day over a 12 week study duration.
The primary efficacy variable was the average daily pain score recorded on a Box Scale-11 pain scale in the evening. 0 = no pain and 10 = most pain imaginable. Subjects ticked the box from 0 - 10 which best describes their level of pain.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21477658Conaghan PG, O'Brien CM, Wilson M, Schofield JP. Transdermal buprenorphine plus oral paracetamol vs an oral codeine-paracetamol combination for osteoarthritis of hip and/or knee: a randomised trial. Osteoarthritis Cartilage. 2011 Aug;19(8):930-8. doi: 10.1016/j.joca.2011.03.011. Epub 2011 Apr 6.
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
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.
Prof Philip Conaghan principal investigator
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 Buprenorphine and Codeine paracetamol in people with Osteoarthritis, 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 4 inclusion and 3 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 14 Jun 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 30 Mar 2010). 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 Scores - BS11 Pain Scores. (time frame: every day over a 12 week study duration.). 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 NCT00324038, which also lists 1 linked publication.
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 14 Jun 2011.