Osteoarthritis; KneePhase 3NCT00316784
IDEA-033 Three Months Dose Finding in OA Followed by IDEA-033 Three Months Extension in OA
A Phase 3 study testing IDEA-033 (and rescue medication) in people with Osteoarthritis; Knee, run by IDEA AG.
Trial summary
The study objective is the eluciation of the dose-response function in efficacy (and possibly safety) in order to determine an optimal dose with respect to efficacy and safety. The study is designed with three dose levels and one placebo control. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis; Knee
- What is being tested?
- IDEA-033 (and rescue medication)
- How many people
- 704 participants
- Where
- No sites listed yet
- Study dates
- Jul 2005to May 2006
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of OA in at least one knee for a minimum of 6 months
- aged 18-75 years old
- eligible subjects must have used an oral or rectal NSAID on at least three days per week during the three months before screening or on at least 25 of the 30 days before screening, but be dissatisfied with the current NSAID treatment
- at baseline visit WOMAC pain subscale at least 40 mm, and at least 15 mm greater than at the screening visit in the index knee
- radiographic evidence consistent with OA criteria of grade 2 or 3 according to Kellgren \& Lawrence in the index knee. Radiographs mus have been taken during the 6 months before baseline.
- American College of Rheumatology (ACR) functional class I, II or III
Who cannot join
- intraarticular injections or arthroscopy of the index knee within 3 months prior to screening, or planned during the study
- history, physical examinations or radiographs suggestive of other rhematic diseases
- known hypersensitivity or contraindication to ketoprofen; NSAID idiosyncrasy
- history of peptic ulcers
- severe liver or gastro-intestinal disease within the last 6 months
- injections or change in oral treatment regimen of glucosamine, chondroitin sulfate, hyaluronic acid, shark cartilage, or vitamin E within 3 months prior to screening
Show all 9Show fewer
- oral or parenteral corticosteroids within 3 months prior to screening
- analgesic therapy for chronic or recurrent pain conditions for indications other than OA
- immunosuppressants within 3 months prior to screening
About this study
Official title: A Double-Blind, Placebo-Controlled Evaluation of Dose Related Safety and Efficacy of Epicutaneously Applied IDEA-033 for 3 Months Treatment of OA of the Knee Followed by a Double-Blind, Dose-Controlled Evaluation of Safety and Efficacy of Epicutaneously Applied IDEA-033 for 12 Weeks Treatment of OA of the Knee
The study objective is the eluciation of the dose-response function in efficacy (and possibly safety) in order to determine an optimal dose with respect to efficacy and safety. The study is designed with three dose levels and one placebo control.
- Conditions
- Osteoarthritis; Knee
- Being tested
- IDEA-033 (and rescue medication)
- Keywords
- osteoarthritis; knee; IDEA-033
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDEA-033 (and rescue medication)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline at week 12 (or end of study measurements) on the Visual Analogue Scale version of the entire WOMAC Pain subscale (primary)
patient global assessment of response to therapy measured on a 5-point Likert Scale at week 12 or end of study measurements (co-primary)
change from baseline at week 12 (or end of study measurements) on the Visual Analogue Scale version of the entire WOMAC function subscale (co-primary)
Secondary outcomes (5)
Change from baseline at week 12 (or end of study measurements) for Physician's Global Assessment of OA and for observed function (TUG)
Mean number of rescue medication taken per day while in the study
Number of withdrawals and time to discontinuation of the study due to lack of efficacy
Time to onset (in days) of pain relief and time to onset of new flares during treatment
Change from baseline on the vitality subscale of the SF-36 health survey and the EURO QoL
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2006 (estimated)
- Study startJul 2005
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 704 participants
Sponsor and investigators
- Lead sponsor
- IDEA AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gerold Stucki, Prof, MD, Principal investigator, department of physical medicine and rehabilitation of universtity Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00316784
- Sponsor's protocol ID
- CL-033-III-02/E
- Status last verified
- Mar 2009
- First submitted
- 19 Apr 2006
- Last updated
- 20 Mar 2009
- Results posted
- No
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 Dose Related Safety and Efficacy of Epicutaneously Applied IDEA-033 for 3 Months Treatment of OA of the Knee Followed by a Double-Blind, Dose-Controlled Evaluation of Safety and Efficacy of Epicutaneously Applied IDEA-033 for 12 Weeks Treatment of OA of the Knee
- ClinicalTrials.gov ID
- NCT00316784
- Acronym / sponsor ID
- CL-033-III-02/E
- Conditions
- Osteoarthritis; Knee
- Keywords
- osteoarthritis; knee; IDEA-033
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 704 participants
- Lead sponsor
- IDEA AGIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Study completion
- May 2006
- First posted
- 21 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 study objective is the eluciation of the dose-response function in efficacy (and possibly safety) in order to determine an optimal dose with respect to efficacy and safety. The study is designed with three dose levels and one placebo control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- clinical diagnosis of OA in at least one knee for a minimum of 6 months
- aged 18-75 years old
- eligible subjects must have used an oral or rectal NSAID on at least three days per week during the three months before screening or on at least 25 of the 30 days before screening, but be dissatisfied with the current NSAID treatment
- at baseline visit WOMAC pain subscale at least 40 mm, and at least 15 mm greater than at the screening visit in the index knee
- radiographic evidence consistent with OA criteria of grade 2 or 3 according to Kellgren \& Lawrence in the index knee. Radiographs mus have been taken during the 6 months before baseline.
Key exclusion criteria (9 listed)
- intraarticular injections or arthroscopy of the index knee within 3 months prior to screening, or planned during the study
- history, physical examinations or radiographs suggestive of other rhematic diseases
- known hypersensitivity or contraindication to ketoprofen; NSAID idiosyncrasy
- history of peptic ulcers
- severe liver or gastro-intestinal disease within the last 6 months
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 |
|---|---|---|
| IDEA-033 (and rescue medication) | Drug | – |
Primary outcome
change from baseline at week 12 (or end of study measurements) on the Visual Analogue Scale version of the entire WOMAC Pain subscale (primary)
patient global assessment of response to therapy measured on a 5-point Likert Scale at week 12 or end of study measurements (co-primary)
change from baseline at week 12 (or end of study measurements) on the Visual Analogue Scale version of the entire WOMAC function subscale (co-primary)
5 secondary outcomes
Change from baseline at week 12 (or end of study measurements) for Physician's Global Assessment of OA and for observed function (TUG)
Mean number of rescue medication taken per day while in the study
Number of withdrawals and time to discontinuation of the study due to lack of efficacy
Time to onset (in days) of pain relief and time to onset of new flares during treatment
Change from baseline on the vitality subscale of the SF-36 health survey and the EURO QoL
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.
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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.
Gerold Stucki, Prof, MD principal investigator
department of physical medicine and rehabilitation of universtity Munich
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IDEA-033 (and rescue medication) 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 6 inclusion and 9 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 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?
change from baseline at week 12 (or end of study measurements) on the Visual Analogue Scale version of the entire WOMAC Pain subscale (primary). The study lists 3 primary outcomes in all. 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 20 Mar 2009.