Osteoarthritis, KneePhase 2NCT00317733
Ketoprofen in Transfersome Compared to Oral Celecoxib and Placebo for Pain Associated With Osteoarthritis of the Knee
A Phase 2 study testing Ketoprofen in Transfersome in people with Osteoarthritis, Knee, run by IDEA AG.
Trial summary
The purpose of this study is to determine the safety and effectiveness of 110 mg ketoprofen in Transfersome applied to the skin twice daily as compared to placebo and oral celecoxib 200 mg per day for the relief of signs and symptoms of osteoarthritis of the knee for a period of six weeks. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Ketoprofen in Transfersome
- How many people
- 360 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Jan 2004
- Phase
- Phase 2
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Osteoarthritis of the knee for a minimum of six months
- Patient´s rating of pain in the index knee while not taking oral NSAIDs of at least 3 using a 5-point Likert scale
- Presenting two out of the three following criteria - Morning stiffness of less than 30 minutes duration, Crepitus on motion, Age >= 40 years
- Patients must have used oral NSAIDs at least 3 days per week for the 3 months prior to screening or the patient was taking an NSAID on a regular basis (>25 out of 30 days) at a therapeutic level for at least 30 days prior to screening
- Each of the following three criteria (the osteoarthritis flare criteria) must be met - Index knee pain assessment at walking at least 40 mm on VAS at baseline, Increase of index knee pain at walking by at least 15 mm on VAS at baseline compared to screening, Physician´s global assessment of osteoarthritis 3-5 and at least 1 grade increase from screening
Who cannot join
- Grade 1 or Grade 4 severity of the index knee based on Kellgren and Lawrence radiographic criteria
- Intraarticular injections or arthroscopy of the index knee within 3 months prior to screening
- Signs of any clinically important inflammation of the index knee including redness, warmth and or a large bulging effusion with the loss of normal contour
- Crystalline-induced synovitis in the index knee
- History, physical examination or radiographic suggestive of acute inflammatory arthritis, rheumatoid arthritis, psoriatic arthritis, septic arthritis, gout, pseudogout, fibromyalgia, lupus erythematosus, or other types of inflammatory arthritis of the index knee
About this study
Official title: A Double-Blind, Placebo-Controlled Evaluation of Safety and Efficacy of Epicutaneously Applied IDEA-033 (Ketoprofen in Transfersome) in Comparison to Oral Celecoxib for the Treatment of Pain Associated With Osteoarthritis of the Knee
The purpose of this study is to determine the safety and effectiveness of 110 mg ketoprofen in Transfersome applied to the skin twice daily as compared to placebo and oral celecoxib 200 mg per day for the relief of signs and symptoms of osteoarthritis of the knee for a period of six weeks.
Read the detailed description
This is a multicenter, randomized (patients are assigned different treatments based on chance), double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), double-dummy, parallel group, placebo- and active-controlled study to determine the safety and effectiveness of 110 mg of ketoprofen in Transfersome, applied to the skin, in subjects experiencing at least moderate pain when not taking analgesic medication secondary to osteoarthritis pain of the knee. The study hypothesis is that ketoprofen in Transfersome applied to the skin twice daily will be more effective than placebo for the relief of the signs and symptoms of osteoarthritis of the knee as measured by the Visual Analog Scale (VAS) of the Western Ontario and McMaster Universities Index (WOMAC) pain, WOMAC function and subject global asessment of response to therapy at Week 6. WOMAC is a questionaire consisting of 24 questions designed to assess the three dimensions of pain, disability and joint stiffness in osteoarthritis of the knee. Safety evaluations include reports of adverse events, laboratory tests and skin irritation.
Patients will receive one of the following treatments for six weeks - 110 mg ketoprofen in Transfersome applied to the skin twice per day plus one placebo capsule administered orally twice per day, 100 mg celecoxib administered orally twice per day plus placebo Transfersome applied to the skin twice per day, Placebo Transfersome applied to the skin twice per day plus one placebo capsule administered orally twice twice per day.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Ketoprofen in Transfersome
- Keywords
- Ketoprofen, Transfersome, Osteoarthritis, Knee
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketoprofen in TransfersomeDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline at Week 6 on the VAS version of the WOMAC pain subscale; Change from baseline at Week 6 on the VAS version of the WOMAC function subscale; Subject global assessment of response to therapy measured on a 5-point Likert scale at Week 6
Secondary outcomes (1)
Change from baseline at Weeks 2 and 4 for WOMAC pain and physical function scores; Subject global assessment of response to therapy at Weeks 2 and 4; Physician's global assesment of osteoarthritis at Weeks 2, 4 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2006 (estimated)
- Study completionJan 2004
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, 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 360 participants
Sponsor and investigators
- Lead sponsor
- IDEA AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- McNeil Consumer & Specialty Pharmaceuticals Clinical Trial, Study director, McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00317733
- Sponsor's protocol ID
- CL-033-II-03
- Status last verified
- Mar 2009
- First submitted
- 21 Apr 2006
- Last updated
- 20 Mar 2009
- Results posted
- No
Publications
Rother M, Lavins BJ, Kneer W, Lehnhardt K, Seidel EJ, Mazgareanu S. Efficacy and safety of epicutaneous ketoprofen in Transfersome (IDEA-033) versus oral celecoxib and placebo in osteoarthritis of the knee: multicentre randomised controlled trial. Ann Rheum Dis. 2007 Sep;66(9):1178-83. doi: 10.1136/ard.2006.065128. Epub 2007 Mar 15.
PubMed 17363401
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Evaluation of Safety and Efficacy of Epicutaneously Applied IDEA-033 (Ketoprofen in Transfersome) in Comparison to Oral Celecoxib for the Treatment of Pain Associated With Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT00317733
- Acronym / sponsor ID
- CL-033-II-03
- Conditions
- Osteoarthritis, Knee
- Keywords
- Ketoprofen, Transfersome, Osteoarthritis, Knee
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants
- Lead sponsor
- IDEA AGIndustry (pharma, biotech, devices)
- Study completion
- Jan 2004
- First posted
- 25 Apr 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.
The purpose of this study is to determine the safety and effectiveness of 110 mg ketoprofen in Transfersome applied to the skin twice daily as compared to placebo and oral celecoxib 200 mg per day for the relief of signs and symptoms of osteoarthritis of the knee for a period of six weeks.
Detailed description
This is a multicenter, randomized (patients are assigned different treatments based on chance), double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), double-dummy, parallel group, placebo- and active-controlled study to determine the safety and effectiveness of 110 mg of ketoprofen in Transfersome, applied to the skin, in subjects experiencing at least moderate pain when not taking analgesic medication secondary to osteoarthritis pain of the knee. The study hypothesis is that ketoprofen in Transfersome applied to the skin twice daily will be more effective than placebo for the relief of the signs and symptoms of osteoarthritis of the knee as measured by the Visual Analog Scale (VAS) of the Western Ontario and McMaster Universities Index (WOMAC) pain, WOMAC function and subject global asessment of response to therapy at Week 6. WOMAC is a questionaire consisting of 24 questions designed to assess the three dimensions of pain, disability and joint stiffness in osteoarthritis of the knee. Safety evaluations include reports of adverse events, laboratory tests and skin irritation.
Patients will receive one of the following treatments for six weeks - 110 mg ketoprofen in Transfersome applied to the skin twice per day plus one placebo capsule administered orally twice per day, 100 mg celecoxib administered orally twice per day plus placebo Transfersome applied to the skin twice per day, Placebo Transfersome applied to the skin twice per day plus one placebo capsule administered orally twice twice per day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Osteoarthritis of the knee for a minimum of six months
- Patient´s rating of pain in the index knee while not taking oral NSAIDs of at least 3 using a 5-point Likert scale
- Presenting two out of the three following criteria - Morning stiffness of less than 30 minutes duration, Crepitus on motion, Age >= 40 years
- Patients must have used oral NSAIDs at least 3 days per week for the 3 months prior to screening or the patient was taking an NSAID on a regular basis (>25 out of 30 days) at a therapeutic level for at least 30 days prior to screening
- Each of the following three criteria (the osteoarthritis flare criteria) must be met - Index knee pain assessment at walking at least 40 mm on VAS at baseline, Increase of index knee pain at walking by at least 15 mm on VAS at baseline compared to screening, Physician´s global assessment of osteoarthritis 3-5 and at least 1 grade increase from screening
Key exclusion criteria (5 listed)
- Grade 1 or Grade 4 severity of the index knee based on Kellgren and Lawrence radiographic criteria
- Intraarticular injections or arthroscopy of the index knee within 3 months prior to screening
- Signs of any clinically important inflammation of the index knee including redness, warmth and or a large bulging effusion with the loss of normal contour
- Crystalline-induced synovitis in the index knee
- History, physical examination or radiographic suggestive of acute inflammatory arthritis, rheumatoid arthritis, psoriatic arthritis, septic arthritis, gout, pseudogout, fibromyalgia, lupus erythematosus, or other types of inflammatory arthritis of the index knee
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 |
|---|---|---|
| Ketoprofen in Transfersome | Drug | – |
Primary outcome
Change from baseline at Week 6 on the VAS version of the WOMAC pain subscale; Change from baseline at Week 6 on the VAS version of the WOMAC function subscale; Subject global assessment of response to therapy measured on a 5-point Likert scale at Week 6
1 secondary outcome
Change from baseline at Weeks 2 and 4 for WOMAC pain and physical function scores; Subject global assessment of response to therapy at Weeks 2 and 4; Physician's global assesment of osteoarthritis at Weeks 2, 4 and 6
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 20 Mar 2009.
- Results publication: PubMed 17363401Rother M, Lavins BJ, Kneer W, Lehnhardt K, Seidel EJ, Mazgareanu S. Efficacy and safety of epicutaneous ketoprofen in Transfersome (IDEA-033) versus oral celecoxib and placebo in osteoarthritis of the knee: multicentre randomised controlled trial. Ann Rheum Dis. 2007 Sep;66(9):1178-83. doi: 10.1136/ard.2006.065128. Epub 2007 Mar 15.
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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.
McNeil Consumer & Specialty Pharmaceuticals Clinical Trial study director
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ketoprofen in Transfersome in people with Osteoarthritis, Knee, run by IDEA AG.
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 5 inclusion and 5 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 20 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change from baseline at Week 6 on the VAS version of the WOMAC pain subscale; Change from baseline at Week 6 on the VAS version of the WOMAC function subscale; Subject global assessment of response to therapy measured on a 5-point Likert scale at Week 6. 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 NCT00317733, 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 20 Mar 2009.