OsteoarthritisPhase 4NCT01019265
A Study Comparing Norspan Patch and Oral Tramadol
A Phase 4 study testing Buprenorphine 5mg, 10mg, 20mg vs Tramadol 100mg in people with Osteoarthritis, run by Mundipharma Korea Ltd at 5 sites in South Korea.
Trial summary
This trial was designed for comparison and evaluation of the efficacy and safety of buprenorphine transdermal patch (Norspan® patch 5 mg, 10 mg and 20mg) against oral tramadol (Tridol® SR (slow release) tablet 100mg) in patients with moderate to severe pain due to osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Buprenorphine 5mg, 10mg, 20mg vs Tramadol 100mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 5 sitesSouth Korea
- Study dates
- Mar 2008to May 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 more than 18 years.
- Clinical diagnosis of osteoarthritis (OA) of the hip and/or knee including fulfilling the American College of Rheumatology Criteria (ACR criteria L13) and documentation of osteoarthritis in the relevant joint.
- Patients with moderate to severe osteoarthritis pain in the relevant joint, confirmed by BS-11 (Box Scale-11) more than 4 for their pain on average during the last week, in their primary OA joint, at both the screening and base line visits despite treatment with non-opioid analgesics.
Who cannot join
- Patients being treated with high potency opioid analgesics (e.g., morphine, fentanyl, oxycodone, methadone, hydromorphone, ketobemidone, buprenorphine (including Norspan®)) for their osteoarthritis pain.
- Patients who have been taking any opioid analgesics within the last 4 weeks prior to the screening visit.
- Patients who have been using any (Non-steroidal Anti-Infammatory) NSAID transdermal preparation less than 2 weeks prior to the screening visit.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Asan Medical Center
Seoul
Hanyang University Medical Center
Seoul
National Medical Center
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
About this study
Official title: A Randomised Open Label Parallel Group Study Comparing Norspan Patch and Oral Tramadol
This trial was designed for comparison and evaluation of the efficacy and safety of buprenorphine transdermal patch (Norspan® patch 5 mg, 10 mg and 20mg) against oral tramadol (Tridol® SR (slow release) tablet 100mg) in patients with moderate to severe pain due to osteoarthritis.
Read the detailed description
The primary objective of this non-inferiority study with active, parallel control group is to compare and assess efficacy and safety of buprenorphine transdermal patch (Norspan® Patch 5 mg, 10 mg and 20 mg) and tramadol (Tridol® SR (slow release) Tablet 100mg) in patients with moderate to severe pain due to osteoarthritis. During the period of treatment for 8weeks, titration and maintenance is kept up after 1:1 ratio randomization.
- Conditions
- Osteoarthritis
- Being tested
- Buprenorphine 5mg, 10mg, 20mg vs Tramadol 100mg
- Keywords
- Norspan patch, Buprenorphine transdermal patch (BTDS), efficacy, buprenorphine
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buprenorphine 5mg, 10mg, 20mg vs Tramadol 100mgDrug
Also called Norspan patch, Buprenorphine transdermal system (BTDS)
Comparing pain intensity between intervention drugs (Norspan® and Tridol®)
| Study group | Role | What they receive |
|---|---|---|
| Norspan patch (Buprenorphine TDS) | Experimental | Not described Receives: Drug: Buprenorphine 5mg, 10mg, 20mg vs Tramadol 100mg |
| TramadolSR tab (Tridol SR tab) | Active comparator | Not described Receives: Drug: Buprenorphine 5mg, 10mg, 20mg vs Tramadol 100mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity - BS (box score)-11 pain scale
Measured: 8 weeks
Secondary outcomes (3)
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Measured: 8 weeks
Degree of sleep disturbance due to pain and improvement in quality of sleep
Measured: 8 weeks
Incidence of early discontinuation due to lack of efficacy
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startMar 2008
- Primary completionMar 2009
- Study completionMay 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mundipharma Korea Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Myun Chul Lee, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01019265
- Sponsor's protocol ID
- BUP07-KR-001
- Status last verified
- Jul 2015
- First submitted
- 24 Nov 2009
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Open Label Parallel Group Study Comparing Norspan Patch and Oral Tramadol
- ClinicalTrials.gov ID
- NCT01019265
- Acronym / sponsor ID
- BUP07-KR-001
- Conditions
- Osteoarthritis
- Keywords
- Norspan patch, Buprenorphine transdermal patch (BTDS), efficacy, buprenorphine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Mundipharma Korea LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 25 Nov 2009 (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.
This trial was designed for comparison and evaluation of the efficacy and safety of buprenorphine transdermal patch (Norspan® patch 5 mg, 10 mg and 20mg) against oral tramadol (Tridol® SR (slow release) tablet 100mg) in patients with moderate to severe pain due to osteoarthritis.
Detailed description
The primary objective of this non-inferiority study with active, parallel control group is to compare and assess efficacy and safety of buprenorphine transdermal patch (Norspan® Patch 5 mg, 10 mg and 20 mg) and tramadol (Tridol® SR (slow release) Tablet 100mg) in patients with moderate to severe pain due to osteoarthritis. During the period of treatment for 8weeks, titration and maintenance is kept up after 1:1 ratio randomization.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Norspan patch (Buprenorphine TDS) | Experimental | Drug: Buprenorphine 5mg, 10mg, 20mg vs Tramadol 100mg |
| TramadolSR tab (Tridol SR tab) | Active comparator | Drug: Buprenorphine 5mg, 10mg, 20mg vs Tramadol 100mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females aged more than 18 years.
- Clinical diagnosis of osteoarthritis (OA) of the hip and/or knee including fulfilling the American College of Rheumatology Criteria (ACR criteria L13) and documentation of osteoarthritis in the relevant joint.
- Patients with moderate to severe osteoarthritis pain in the relevant joint, confirmed by BS-11 (Box Scale-11) more than 4 for their pain on average during the last week, in their primary OA joint, at both the screening and base line visits despite treatment with non-opioid analgesics.
Key exclusion criteria (3 listed)
- Patients being treated with high potency opioid analgesics (e.g., morphine, fentanyl, oxycodone, methadone, hydromorphone, ketobemidone, buprenorphine (including Norspan®)) for their osteoarthritis pain.
- Patients who have been taking any opioid analgesics within the last 4 weeks prior to the screening visit.
- Patients who have been using any (Non-steroidal Anti-Infammatory) NSAID transdermal preparation less than 2 weeks prior to the screening visit.
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 5mg, 10mg, 20mg vs Tramadol 100mgAlso: Norspan patch, Buprenorphine transdermal system (BTDS)Comparing pain intensity between intervention drugs (Norspan® and Tridol®) | Drug | Norspan patch (Buprenorphine TDS), TramadolSR tab (Tridol SR tab) |
Primary outcome
Pain intensity - BS (box score)-11 pain scale
Time frame: 8 weeks
3 secondary outcomes
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: 8 weeks
Degree of sleep disturbance due to pain and improvement in quality of sleep
Time frame: 8 weeks
Incidence of early discontinuation due to lack of efficacy
Time frame: 8 weeks
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 8 Jul 2015.
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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.
Myun Chul Lee principal investigator
Seoul National University Hospital
5 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 5mg, 10mg, 20mg vs Tramadol 100mg in people with Osteoarthritis, run by Mundipharma Korea Ltd at 5 sites in South Korea.
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 8 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. 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?
Pain intensity - BS (box score)-11 pain scale (time frame: 8 weeks). 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 8 Jul 2015.