Osteoarthritis of the KneePhase 3NCT00716547
Safety and Efficacy of Two Dosages of Diractin® in Osteoarthritis (OA)
A Phase 3 study testing ketoprofen in Diractin® and celecoxib in people with Osteoarthritis of the Knee, run by IDEA AG at 4 sites in 4 countries.
Trial summary
The purpose of this study is to provide replicated evidence of safety and efficacy of 50 mg and 100 mg ketoprofen in Diractin®. Read more about this study
- Who is it for?
- Ages 46 years and older
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- ketoprofen in Diractin® and celecoxib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,399 participants
- Where
- 4 sitesin 4 countries
- Study dates
- May 2008to May 2009
- Phase
- Phase 3
- 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 46 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent signed and dated
- Age > 45 years
- Class I-III OA of the knee and subject meets American College of Rheumatology (ACR) clinical classification criteria for osteoarthritis of the knee
Who cannot join
- Skin lesions or dermatological diseases in the treatment area
- Directly or indirectly involved in the conduct and administration of this study
- Received any investigational medicinal product within 30 days prior to Screening Visit or participation in any previous clinical study with Diractin®
- Pregnancy or lactation
- Residents of psychiatric wards, prisons or other state institutions
- Malignancy within the past 2 years
Show all 19Show fewer
- Depressive disorders requiring treatment with tricyclics, treatment with other antidepressants must be stable for 3 months prior to screening and throughout the study
- Epilepsy
- Schizophrenia
- Neuropathic pain and any other pain condition requiring chronic use of pain medication
- Known hypersensitivity or allergy (including photoallergy) to NSAID´s including ketoprofen, celecoxib, sulfonamides and ingredients used in pharmaceutical products including galactose
- Peripheral arterial disease and/or cerebrovascular disease
- History of stroke or myocardial infarction
- Congestive Heart failure NYHA Class II-IV
- History of pancreatitis or peptic ulcers;
- Inflammatory GI disease (e.g. M. Crohn, colitis ulcerosa)
- Serum creatinine levels > 2.5 milligrams/deciliter (mg/dL)
- ALT or AST levels ≥ 5 times the ULN
- Unable to discontinue analgesic therapy including opioids, NSAID´s, tramadol, muscle relaxants, gabapentin, pregabalin, duloxetine, venlafaxine, capsaicine or other drugs approved or used for the treatment of pain for the duration of the study
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: Multicenter, Randomized, Double-blind, Placebo- and Active-controlled Study of Safety and Efficacy of Two Dosages of Epicutaneously Applied Diractin® (Ketoprofen in Transfersome® Gel) for the Treatment of Osteoarthritis of the Knee
The purpose of this study is to provide replicated evidence of safety and efficacy of 50 mg and 100 mg ketoprofen in Diractin®.
Read the detailed description
The study will investigate safety and efficacy of 2 dosages of Diractin®at relieving the signs and symptoms of knee OA, including the primary endpoint of patient assessment of pain.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- ketoprofen in Diractin®, Placebo, celecoxib
- 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 Diractin®Drug
50 mg (b.i.d.)
ketoprofen in Diractin®Drug
100 mg (b.i.d.)
PlaceboDrug
b.i.d.
celecoxibDrug
100 mg (b.i.d.)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: ketoprofen in Diractin® |
| 2 | Experimental | Not described Receives: Drug: ketoprofen in Diractin® |
| 3 | Active comparator | Not described Receives: Drug: celecoxib |
| 4 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain subscale of the WOMAC
Measured: week 12
Secondary outcomes (2)
Patient global assessment of response to therapy
Measured: week 12
function subscale of the WOMAC
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2008 (estimated)
- Study startMay 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis of the 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,399 participants (actual)
Sponsor and investigators
- Lead sponsor
- IDEA AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- IDEA AG Clinical Trial, Study director, IDEA AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00716547
- Sponsor's protocol ID
- CL-033-III-03
- Status last verified
- Oct 2009
- First submitted
- 14 Jul 2008
- Last updated
- 16 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Conaghan PG, Dickson J, Bolten W, Cevc G, Rother M. A multicentre, randomized, placebo- and active-controlled trial comparing the efficacy and safety of topical ketoprofen in Transfersome gel (IDEA-033) with ketoprofen-free vehicle (TDT 064) and oral celecoxib for knee pain associated with osteoarthritis. Rheumatology (Oxford). 2013 Jul;52(7):1303-12. doi: 10.1093/rheumatology/ket133. Epub 2013 Mar 28.
PubMed 23542612
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-blind, Placebo- and Active-controlled Study of Safety and Efficacy of Two Dosages of Epicutaneously Applied Diractin® (Ketoprofen in Transfersome® Gel) for the Treatment of Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT00716547
- Acronym / sponsor ID
- CL-033-III-03
- Conditions
- Osteoarthritis of the Knee
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,399 participants (actual)
- Lead sponsor
- IDEA AGIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 16 Jul 2008 (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 provide replicated evidence of safety and efficacy of 50 mg and 100 mg ketoprofen in Diractin®.
Detailed description
The study will investigate safety and efficacy of 2 dosages of Diractin®at relieving the signs and symptoms of knee OA, including the primary endpoint of patient assessment of pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ketoprofen in Diractin® |
| 2 | Experimental | Drug: ketoprofen in Diractin® |
| 3 | Active comparator | Drug: celecoxib |
| 4 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 46 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informed consent signed and dated
- Age > 45 years
- Class I-III OA of the knee and subject meets American College of Rheumatology (ACR) clinical classification criteria for osteoarthritis of the knee
Key exclusion criteria (19 listed)
- Skin lesions or dermatological diseases in the treatment area
- Directly or indirectly involved in the conduct and administration of this study
- Received any investigational medicinal product within 30 days prior to Screening Visit or participation in any previous clinical study with Diractin®
- Pregnancy or lactation
- Residents of psychiatric wards, prisons or other state institutions
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 Diractin®50 mg (b.i.d.) | Drug | 1 |
| ketoprofen in Diractin®100 mg (b.i.d.) | Drug | 2 |
| Placebob.i.d. | Drug | 4 |
| celecoxib100 mg (b.i.d.) | Drug | 3 |
Primary outcome
pain subscale of the WOMAC
Time frame: week 12
2 secondary outcomes
Patient global assessment of response to therapy
Time frame: week 12
function subscale of the WOMAC
Time frame: week 12
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 16 Oct 2009.
- Derived from this study: PubMed 23542612Conaghan PG, Dickson J, Bolten W, Cevc G, Rother M. A multicentre, randomized, placebo- and active-controlled trial comparing the efficacy and safety of topical ketoprofen in Transfersome gel (IDEA-033) with ketoprofen-free vehicle (TDT 064) and oral celecoxib for knee pain associated with osteoarthritis. Rheumatology (Oxford). 2013 Jul;52(7):1303-12. doi: 10.1093/rheumatology/ket133. Epub 2013 Mar 28.
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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.
IDEA AG Clinical Trial study director
IDEA AG
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ketoprofen in Diractin® and celecoxib in people with Osteoarthritis of the Knee, run by IDEA AG at 4 sites in 4 countries.
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 19 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 16 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Czechia, Germany, Poland, United Kingdom. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 subscale of the WOMAC (time frame: week 12). 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 NCT00716547, 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 16 Oct 2009.