OsteoarthritisPhase 4NCT00399178
A Randomised Open Controlled Parallel Group Study Comparing Norspan and Tramadol
A Phase 4 study testing Transdermal delivery system in people with Osteoarthritis, run by Mundipharma AB at 1 site in Sweden.
Trial summary
To evaluate the efficacy and safety of Norspan versus Tiperol Retard among OA patients who are sub-optimally treated with current analgesic. Those patients may benefit from treatment with a long lasting analgesic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Transdermal delivery system
- How many people
- 160 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2006to Jun 2007
- 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
- Adult, Older adult
Who may be able to join
- OA diagnosis
- BS11 greater than or equal to 4 at base line
- Not adequately pain relieved with 4,000 mg paracetamol daily
Who cannot join
- Treated with high potent opioids for their OA pain
- Treated with a regular dose for greater than one week of Tramadol, Codeine or dextropropoxifene during the last three months
- Other chronic conditions requiring frequent analgesic therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Open Controlled Parallel Group Multicenter Study to Evaluate the Efficacy and Safety of Norspan Versus Tiparol Retard in Subjects With Chronic Moderate to Severe OA Pain of the Hip and/or Knee.
To evaluate the efficacy and safety of Norspan versus Tiperol Retard among OA patients who are sub-optimally treated with current analgesic. Those patients may benefit from treatment with a long lasting analgesic.
- Conditions
- Osteoarthritis
- Being tested
- Transdermal delivery system
- Keywords
- Osteoarthritis, Norspan versus Tramadol, Randomised, Efficacy and safety, OA pain of the hip and/or knee
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdermal delivery systemDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Box Scale 11 pain scores for pain on average during the last week then mean change from base line to completion. BS11 is recorded daily by the patients in a diary.
Secondary outcomes (1)
Rescue medication recorded daily by patients. Sleep disturbance and quality of sleep. Patients global assessment of pain relief, investigators global assessment of pain relief, patients preference, WOMAC OA index, EuroQoL EQ-5D.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2006 (estimated)
- Study startNov 2006
- Study completionJun 2007
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
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mundipharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- M Karlsson, Med, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00399178
- Sponsor's protocol ID
- 2006-003233-32
- Other IDs
- BUP4009
- Status last verified
- Nov 2006
- First submitted
- 10 Nov 2006
- Last updated
- 17 Aug 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Open Controlled Parallel Group Multicenter Study to Evaluate the Efficacy and Safety of Norspan Versus Tiparol Retard in Subjects With Chronic Moderate to Severe OA Pain of the Hip and/or Knee.
- ClinicalTrials.gov ID
- NCT00399178
- Acronym / sponsor ID
- 2006-003233-32
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, Norspan versus Tramadol, Randomised, Efficacy and safety, OA pain of the hip and/or knee
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Mundipharma ABIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Study completion
- Jun 2007 (actual)
- First posted
- 14 Nov 2006 (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.
To evaluate the efficacy and safety of Norspan versus Tiperol Retard among OA patients who are sub-optimally treated with current analgesic. Those patients may benefit from treatment with a long lasting analgesic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- OA diagnosis
- BS11 greater than or equal to 4 at base line
- Not adequately pain relieved with 4,000 mg paracetamol daily
Key exclusion criteria (3 listed)
- Treated with high potent opioids for their OA pain
- Treated with a regular dose for greater than one week of Tramadol, Codeine or dextropropoxifene during the last three months
- Other chronic conditions requiring frequent analgesic therapy
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 |
|---|---|---|
| Transdermal delivery system | Drug | – |
Primary outcome
Box Scale 11 pain scores for pain on average during the last week then mean change from base line to completion. BS11 is recorded daily by the patients in a diary.
1 secondary outcome
Rescue medication recorded daily by patients. Sleep disturbance and quality of sleep. Patients global assessment of pain relief, investigators global assessment of pain relief, patients preference, WOMAC OA index, EuroQoL EQ-5D.
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 17 Aug 2007.
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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.
M Karlsson, Med 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 Transdermal delivery system in people with Osteoarthritis, run by Mundipharma AB at 1 site in Sweden.
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 3 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 17 Aug 2007. 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 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 pain scores for pain on average during the last week then mean change from base line to completion. BS11 is recorded daily by the patients in a diary.. 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 17 Aug 2007.