Osteoarthritis Pain of the Hip and or KneePhase 4NCT01276431
Norspan Efficacy and Safety Among Elderly Subjects
A Phase 4 study testing Buprenorphine transdermal patch in people with Osteoarthritis Pain of the Hip and or Knee, run by Mundipharma AB at 2 sites in Sweden.
Trial summary
An open label, multi-centre, prospective age-group-controlled study to evaluate efficacy and safety of buprenorphine transdermal patches in subjects with chronic, moderate to severe osteoarthritis pain of the hip and/or knee. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Osteoarthritis Pain of the Hip and or Knee
- What is being tested?
- Buprenorphine transdermal patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 2 sitesSweden
- Study dates
- Mar 2011to Aug 2012
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Summary Criteria for Inclusion:
- Males and females aged 50-60 or ≥ 75 years.
- Subjects with clinical diagnosis of osteoarthritis in knee and/or hip including fulfilment of ACR-criteria and radiographic evidence not older than one year.
- Subjects with a moderate to severe pain, confirmed by a BS-11 score ≥ 4 for their pain on average during the last seven days of the Screening Phase in their primary OA-site at the Baseline Visit.
Summary Criteria for Exclusion:
- Subjects recording < 4 on average during the Screening Phase on the BS-11 scale.
- Subjects treated with high-potent opioid analgesics (e.g. morphine, fentanyl, oxycodone, methadone, hydromorphone, ketobemidone, buprenorphine) for their osteoarthritis pain.
- Subjects treated with a regular dose for > 1 week of tramadol, codeine or dextropropoxyphene within 1 month before screening visit.
- Subjects who require NSAID treatment (except aspirin for cardiovascular indications) or cox-2-inhibitors during the study period.
- Subjects with history of, or ongoing, chronic condition(s), in addition to osteoarthritis, requiring frequent analgesic therapy (e.g. frequent headaches, frequent migraine, gout, rheumatoid arthritis).
- Subjects scheduled for surgery that would fall within the study period.
- Subjects who currently abused substance or alcohol, or subjects who, in the opinion of the Investigator, have demonstrated addictive or substance abuse behaviours.
- 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 way that participation in the study may, in the opinion of the Investigator, pose an unacceptable risk to the subject.
- Subjects who are currently taking hypnotics, anxiolytics or other central nervous system depressants that, in the Investigator's opinion, may pose a risk of additional CNS depression with study medication.
- Subjects who are currently taking adjuvant analgesics such as antidepressants and anti-convulsants.
- Dermatological disorder or non-intact skin at any relevant patch application site that precludes proper placement and/or rotation of patch placement.
- Subjects who had received an intra-articular steroid injection within 6 weeks prior Screening Visit or subjects who require steroid treatment (oral, intra-muscular, intra-venous, intra-articular, epidural or other corticosteroid injections) during the study period.
- Subjects with joint evacuation 6 weeks prior Screening Visit and during the study.
- Subjects who are currently taking monoamine oxidase inhibitors (MAOI's) or have taken MAOI's within 2 weeks before Screening Visit.
Trial locations and contacts
2 sites in 1 country.
About this study
An open label, multi-centre, prospective age-group-controlled study to evaluate efficacy and safety of buprenorphine transdermal patches in subjects with chronic, moderate to severe osteoarthritis pain of the hip and/or knee.
- Being tested
- Buprenorphine transdermal patch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buprenorphine transdermal patchDrug
| Study group | Role | What they receive |
|---|---|---|
| Buprenorphine transdermal patch | Other | For two age groups: 50-60 years and >= 75 years of age Receives: Drug: Buprenorphine transdermal patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Box Scale-11 (BS-11) pain scores (pain on average during the last seven days, mean change from Baseline to Completion (fulfilled all visits in the study).
Secondary outcomes (6)
Western Ontario & McMaster Universities OA Index
European QOL Health Questionnaire
Sleep disturbance & quality of sleep questions
Patients global assessment of pain relief
Investigators global assessment of pain relief
Incidence of rescue medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2011 (estimated)
- Study startMar 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis Pain of the Hip and or KneeStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mundipharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01276431
- Sponsor's protocol ID
- BUP4504
- Other IDs
- 2010-020748-37
- Status last verified
- Feb 2014
- First submitted
- 10 Jan 2011
- Last updated
- 6 Feb 2014
- Results posted
- No
Publications
Karlsson J, Soderstrom A, Augustini BG, Berggren AC. Is buprenorphine transdermal patch equally safe and effective in younger and elderly patients with osteoarthritis-related pain? Results of an age-group controlled study. Curr Med Res Opin. 2014 Apr;30(4):575-87. doi: 10.1185/03007995.2013.873714. Epub 2013 Dec 23.
PubMed 24320787
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Norspan Efficacy and Safety Among Elderly Subjects
- ClinicalTrials.gov ID
- NCT01276431
- Acronym / sponsor ID
- BUP4504
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Mundipharma ABIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 13 Jan 2011 (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.
An open label, multi-centre, prospective age-group-controlled study to evaluate efficacy and safety of buprenorphine transdermal patches in subjects with chronic, moderate to severe osteoarthritis pain of the hip and/or knee.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Buprenorphine transdermal patch | Other | Drug: Buprenorphine transdermal patchFor two age groups: 50-60 years and >= 75 years of age |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 transdermal patch | Drug | Buprenorphine transdermal patch |
Primary outcome
Box Scale-11 (BS-11) pain scores (pain on average during the last seven days, mean change from Baseline to Completion (fulfilled all visits in the study).
6 secondary outcomes
Western Ontario & McMaster Universities OA Index
European QOL Health Questionnaire
Sleep disturbance & quality of sleep questions
Patients global assessment of pain relief
Investigators global assessment of pain relief
Incidence of rescue medication
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 6 Feb 2014.
- Background: PubMed 24320787Karlsson J, Soderstrom A, Augustini BG, Berggren AC. Is buprenorphine transdermal patch equally safe and effective in younger and elderly patients with osteoarthritis-related pain? Results of an age-group controlled study. Curr Med Res Opin. 2014 Apr;30(4):575-87. doi: 10.1185/03007995.2013.873714. Epub 2013 Dec 23.
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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.
2 sites 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 transdermal patch in people with Osteoarthritis Pain of the Hip and or Knee, run by Mundipharma AB at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 6 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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?
Box Scale-11 (BS-11) pain scores (pain on average during the last seven days, mean change from Baseline to Completion (fulfilled all visits in the study).. 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 NCT01276431, 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 6 Feb 2014.