OsteoarthritisPhase 4NCT00426647
Norspan® Patches Versus Tramadol in Subjects With Chronic, Moderate to Severe Osteoarthritis Pain in the Hip Knee and/or Lumbar Spine
A Phase 4 study testing Buprenorphine and Tramadol in people with Osteoarthritis and Pain, run by Norpharma A/S at 1 site in Finland.
Trial summary
The primary objective of this equivalence study is to evaluate the efficacy of Norspan® patches versus Tramadol in subjects with chronic, moderate to severe osteoarthritis pain of the hip, knee and/or lumbar spine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Pain
- What is being tested?
- Buprenorphine and Tramadol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFinland
- Study dates
- Feb 2007to Aug 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Males and females aged 18 years or more (women of childbearing potential must have a negative pregnancy test, be non-lactating, and willing to use adequate and reliable contraception (defined as IUD, contraceptive pill or depot gestagen) throughout the study) with osteoarthritis in the hip \&/or knee.
- Or Males \& females aged 50 years or more with osteoarthritis in lumbar spine without nerve root pressure.
- Clinical diagnosis of OA in the hip and/or knee including fulfilment of ACR-criteria and radiographic or MR-Scan evidence for the primary OA-joint in hip \&/or knee.
- Or Clinical diagnosis of OA in the lumbar spine without nerve root pressure, \& with radiographic or CT-scan evidence for lumbar OA.
- Subjects with moderate to severe pain confirmed by a BS-11 score > 4 for their pain on average in their primary OA-joint during the last 5 days prior to the Baseline Visit (Randomisation Visit/Visit 4).
- Subjects must previously or during Wash-out-Phase have been treated with 4000 mg Paracetamol IR daily or another analgesic treatment at least comparable to this and not have been adequately pain relieved (defined as BS-11 score > 4 for their pain on average in their Primary OA-joint during 5 continuous days) on that treatment.
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- Subjects must be willing to discontinue all other analgesics (incl. glucosamine) at the Pre-Screening Visit (Visit 1) and until the Completion/Discontinuation Visit (Visit 10).
- Subjects must be able to read and comprehend Danish and be willing to sign informed consent.
- Subjects must be willing and able to fill in a Subject Diary on a daily basis.
Who cannot join
- Subjects treated with high-potent opioid analgesics (e.g. morphine, fentanyl, oxycodone, methadone, hydromorphone, ketobemidone, buprenorphine (incl. Norspan® patches)) for their OA pain. Except subjects treated with high-potent opioid analgesics for up to four continuous weeks for their OA pain beyond 3 months prior to the Pre-screening Visit.
- Subjects treated with high-potent opioid analgesics (e.g. morphine, fentanyl, oxycodone, methadone, hydromorphone, ketobemidone, buprenorphine (incl. Norspan® patches)) within four weeks prior to the Pre-screening Visit due to non-OA pain.
- Subjects treated with more than 200 mg Tramadol daily or 200 mg codeine daily during the last two weeks prior to the Pre-screening Visit.
- History of chronic condition(s), in addition to OA, requiring frequent analgesic therapy (e.g. frequent headaches, frequent migraine, gout, rheumatoid arthritis) and severe respiratory disease.
- Scheduled for surgery that would fall within all phases (Run-in-Phase, Wash-out-Phase, Double-Blind-Phase and Follow-up-Phase) of the study.
- Substance or alcohol abuse, or subjects who, in the opinion of the Investigator, have demonstrated addictive or substance abuse behaviour.
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- Subjects with cancer (except basal cell carcinoma) or history of cancer in the last 5 years (except treated basal cell carcinoma).
- Untreated depression or other psychiatric disorder in such a way that participation in the study may, in the opinion of the Investigator, pose an unacceptable risk to the subject.
- Dermatological disorder at any relevant patch application site that precludes proper placement and/or rotation of patch placement.
- Treatment with steroids (oral, intra-muscular, intra-venous, intra-articular, epidural, or other corticosteroid injections) within 6 weeks prior to the Pre-screening Visit and during the study.
- Intra-articular hyaluron acid injections given within 6 months prior to the Pre-screening Visit and during the study.
- Any joint evacuation carried out within 6 weeks prior to the Pre-screening Visit and during the study.
- Subjects who are currently taking monoamine oxidase inhibitors (MAOIs) or have taken MAOIs within 2 weeks prior to the Pre-screening Visit.
- Participation in a clinical research study involving a new chemical entity within 3 months prior to the Pre-screening Visit.
- Allergies or other contraindications to transdermal systems or patch adhesives.
- Known lack of tolerance and/or effect of Tramadol.
- Known hypersensitivity (allergic reaction) to opioids or Paracetamol.
- Ongoing requirement for and treatment with direct external heat sources such as heat lamps, electric blankets, saunas, heating pads and heated waterbeds.
- New physiotherapy and/or chiropractic and/or other non pharmacological regimen scheduled to commence during the Run-in-Phase, Wash-out-Phase or Double-Blind-Phase of the study. This includes physiotherapy and/or chiropractic and/or other non pharmacological regimen not in a scheduled weekly window.
- Subjects who cannot or will not cut the hair at the patch site for proper placement of the patch.
- Any other contraindications listed in the Summary of Product Characteristics for Norspan® patches or Tramadol.
- Subjects, who are unsuitable for any other reason to participate in the study in the opinion of the Investigator.
Trial locations and contacts
1 site in 1 country.
Finland1 site
Dr. Olavi Airaksinen
Oma Lääkäri Oy, Vuorikatu 20, Kuopio, FIN-70100
About this study
Official title: A Randomised Double-blind Multicentre Equivalence Study With Active Parallel Comparator Group to Evaluate the Efficacy and Safety of Norspan® Patches Versus Tramadol in Subjects With Chronic, Moderate to Severe Osteoarthritis Pain in the Hip, Knee &/or Lumbar Spine.
The primary objective of this equivalence study is to evaluate the efficacy of Norspan® patches versus Tramadol in subjects with chronic, moderate to severe osteoarthritis pain of the hip, knee and/or lumbar spine.
The secondary objectives are to evaluate the safety and general satisfaction for the patients in the two treatment groups.
Read the detailed description
This is a randomised, double-blind, multicentre equivalence study with active comparator, parallel group, to evaluate the efficacy and safety of Norspan® patches versus Tramadol in subjects with OA pain in hip, knee and/or lumbar spine, currently receiving sub-optimal analgesic treatment (defined as BS-11 score > 4) when treated with paracetamol 4000 mg/day or another analgesic at least comparable to this.
The study consist of 4 phases:
Run-in, Wash-out, Double blind and Follow-up
- Conditions
- Osteoarthritis, Pain
- Being tested
- Buprenorphine, Tramadol
- Keywords
- Osteoarthritis, Pain, Norspan, Buprenorphine, Tramadol
- 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
TramadolDrug
| Study group | Role | What they receive |
|---|---|---|
| Buprenorphine | Experimental | Norspan transdermal patch Receives: Drug: Buprenorphine |
| Tramadol | Active comparator | Tramadol SR tablets Receives: Drug: Tramadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Equivalence study to evaluate the efficacy of Norspan® patches versus Tramadol in subjects with chronic, moderate to severe osteoarthritis pain of the hip, knee and/or lumber spine.
Secondary outcomes (1)
To evaluate the safety and general satisfaction for the patients in the two treatment groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2007 (estimated)
- Study startFeb 2007
- Primary completionJul 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norpharma A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mundipharma Finland
- Investigators
- Dorthe Tvinnemose, DVM, Study director, Norpharma A/S, Slotsmarken 15, DK-2970 Hoersholm, DenmarkKim H Kristiansen, DM, Principal investigator, GP, Noerretorv 10, DK-7200 Grindsted, DenmarkOlavi Airaksinen, DM, Principal investigator, Oma Lääkäri Oy, Vuorikatu 20, FIN-70100 KUOPIO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00426647
- Sponsor's protocol ID
- BUP4006
- Other IDs
- NORTOP
- Status last verified
- Jan 2010
- First submitted
- 23 Jan 2007
- Last updated
- 1 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Double-blind Multicentre Equivalence Study With Active Parallel Comparator Group to Evaluate the Efficacy and Safety of Norspan® Patches Versus Tramadol in Subjects With Chronic, Moderate to Severe Osteoarthritis Pain in the Hip, Knee &/or Lumbar Spine.
- ClinicalTrials.gov ID
- NCT00426647
- Acronym / sponsor ID
- BUP4006
- Conditions
- Osteoarthritis, Pain
- Keywords
- Osteoarthritis, Pain, Norspan, Buprenorphine, Tramadol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Norpharma A/SIndustry (pharma, biotech, devices)
- Collaborators
- Mundipharma Finland
- Study start
- Feb 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 25 Jan 2007 (estimated)
- Results
- Not posted in the source record
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 of this equivalence study is to evaluate the efficacy of Norspan® patches versus Tramadol in subjects with chronic, moderate to severe osteoarthritis pain of the hip, knee and/or lumbar spine.
The secondary objectives are to evaluate the safety and general satisfaction for the patients in the two treatment groups.
Detailed description
This is a randomised, double-blind, multicentre equivalence study with active comparator, parallel group, to evaluate the efficacy and safety of Norspan® patches versus Tramadol in subjects with OA pain in hip, knee and/or lumbar spine, currently receiving sub-optimal analgesic treatment (defined as BS-11 score > 4) when treated with paracetamol 4000 mg/day or another analgesic at least comparable to this.
The study consist of 4 phases:
Run-in, Wash-out, Double blind and Follow-up
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buprenorphine | Experimental | Drug: BuprenorphineNorspan transdermal patch |
| Tramadol | Active comparator | Drug: TramadolTramadol SR tablets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males and females aged 18 years or more (women of childbearing potential must have a negative pregnancy test, be non-lactating, and willing to use adequate and reliable contraception (defined as IUD, contraceptive pill or depot gestagen) throughout the study) with osteoarthritis in the hip \&/or knee.
- Or Males \& females aged 50 years or more with osteoarthritis in lumbar spine without nerve root pressure.
- Clinical diagnosis of OA in the hip and/or knee including fulfilment of ACR-criteria and radiographic or MR-Scan evidence for the primary OA-joint in hip \&/or knee.
- Or Clinical diagnosis of OA in the lumbar spine without nerve root pressure, \& with radiographic or CT-scan evidence for lumbar OA.
- Subjects with moderate to severe pain confirmed by a BS-11 score > 4 for their pain on average in their primary OA-joint during the last 5 days prior to the Baseline Visit (Randomisation Visit/Visit 4).
Key exclusion criteria (22 listed)
- Subjects treated with high-potent opioid analgesics (e.g. morphine, fentanyl, oxycodone, methadone, hydromorphone, ketobemidone, buprenorphine (incl. Norspan® patches)) for their OA pain. Except subjects treated with high-potent opioid analgesics for up to four continuous weeks for their OA pain beyond 3 months prior to the Pre-screening Visit.
- Subjects treated with high-potent opioid analgesics (e.g. morphine, fentanyl, oxycodone, methadone, hydromorphone, ketobemidone, buprenorphine (incl. Norspan® patches)) within four weeks prior to the Pre-screening Visit due to non-OA pain.
- Subjects treated with more than 200 mg Tramadol daily or 200 mg codeine daily during the last two weeks prior to the Pre-screening Visit.
- History of chronic condition(s), in addition to OA, requiring frequent analgesic therapy (e.g. frequent headaches, frequent migraine, gout, rheumatoid arthritis) and severe respiratory disease.
- Scheduled for surgery that would fall within all phases (Run-in-Phase, Wash-out-Phase, Double-Blind-Phase and Follow-up-Phase) of the study.
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 |
|---|---|---|
| Buprenorphine | Drug | Buprenorphine |
| Tramadol | Drug | Tramadol |
Primary outcome
Equivalence study to evaluate the efficacy of Norspan® patches versus Tramadol in subjects with chronic, moderate to severe osteoarthritis pain of the hip, knee and/or lumber spine.
1 secondary outcome
To evaluate the safety and general satisfaction for the patients in the two treatment groups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2010.
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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.
Dorthe Tvinnemose, DVM study director
Norpharma A/S, Slotsmarken 15, DK-2970 Hoersholm, Denmark
Kim H Kristiansen, DM principal investigator
GP, Noerretorv 10, DK-7200 Grindsted, Denmark
Olavi Airaksinen, DM principal investigator
Oma Lääkäri Oy, Vuorikatu 20, FIN-70100 KUOPIO
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 Tramadol in people with Osteoarthritis and Pain, run by Norpharma A/S 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 9 inclusion and 22 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 1 Feb 2010. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Equivalence study to evaluate the efficacy of Norspan® patches versus Tramadol in subjects with chronic, moderate to severe osteoarthritis pain of the hip, knee and/or lumber spine.. 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 1 Feb 2010.