Knee OsteoarthritisPhase 4NCT00445276
Symptomatic Efficacy of Diacerein in Knee Osteoarthritis
A Phase 4 study testing Diacerein in people with Knee Osteoarthritis, run by Laboratoires NEGMA at 1 site in France.
Trial summary
Pain is the main symptom of osteoarthritis that motivates medical visits. Diacerhein has already demonstrated its efficacy in knee and/or hip osteoarthritis. This study aims at confirming the efficacy of diacerhein in symptomatic knee osteoarthritis using known and validated criteria and according to the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Diacerein
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2005to Sep 2006
- 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
- Painful primary osteoarthritis (VAS ≥ 40 mm)
- Radiologically proven (Kellgren \& Lawrence grade I to III)
- Requiring the prescription of a symptomatic treatment of pain
Who cannot join
- Severe associated diseases
- Wash-out: AINS, Coxibs, Paracetamol, anti-osteoarthritic treatments, hyaluronic acid, knee tidal lavage
- Other osteoarticular disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy Study of Diacerein in the Symptomatic Treatment of Knee Osteoarthritis
Pain is the main symptom of osteoarthritis that motivates medical visits. Diacerhein has already demonstrated its efficacy in knee and/or hip osteoarthritis. This study aims at confirming the efficacy of diacerhein in symptomatic knee osteoarthritis using known and validated criteria and according to the recommendations and guidelines for this kind of study.
- Conditions
- Knee Osteoarthritis
- Being tested
- Diacerein
- Keywords
- Osteoarthritis, Knee, Diacerein, Painful osteoarthritis, Clinical trial
- 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.
DiacereinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS on pain movement, WOMAC A 1.1 section
Secondary outcomes (5)
WOMAC : total, pain, physical function
Paracetamol consumption
Global assessment of the patient
Responder patients with OMERACT-OARSI criteria
Tolerance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2007 (estimated)
- Study startNov 2005
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee 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
- Double blind
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- Laboratoires NEGMA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jean - Pierre Valat, Principal investigator, Unafilliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00445276
- Sponsor's protocol ID
- HEC / ART 05 566 N
- Other IDs
- AFSSAPS:050984, CCPPRB:2005-27
- Status last verified
- Mar 2010
- First submitted
- 6 Mar 2007
- Last updated
- 4 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study of Diacerein in the Symptomatic Treatment of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT00445276
- Acronym / sponsor ID
- HEC / ART 05 566 N
- Conditions
- Knee Osteoarthritis
- Keywords
- Osteoarthritis, Knee, Diacerein, Painful osteoarthritis, Clinical trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- Laboratoires NEGMAIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 8 Mar 2007 (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.
Pain is the main symptom of osteoarthritis that motivates medical visits. Diacerhein has already demonstrated its efficacy in knee and/or hip osteoarthritis. This study aims at confirming the efficacy of diacerhein in symptomatic knee osteoarthritis using known and validated criteria and according to the recommendations and guidelines for this kind of study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Painful primary osteoarthritis (VAS ≥ 40 mm)
- Radiologically proven (Kellgren \& Lawrence grade I to III)
- Requiring the prescription of a symptomatic treatment of pain
Key exclusion criteria (3 listed)
- Severe associated diseases
- Wash-out: AINS, Coxibs, Paracetamol, anti-osteoarthritic treatments, hyaluronic acid, knee tidal lavage
- Other osteoarticular disease
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 |
|---|---|---|
| Diacerein | Drug | – |
Primary outcome
VAS on pain movement, WOMAC A 1.1 section
5 secondary outcomes
WOMAC : total, pain, physical function
Paracetamol consumption
Global assessment of the patient
Responder patients with OMERACT-OARSI criteria
Tolerance
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 4 Mar 2010.
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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.
Jean - Pierre Valat principal investigator
Unafilliated
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 Diacerein in people with Knee Osteoarthritis, run by Laboratoires NEGMA at 1 site in France.
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 4 Mar 2010. 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 France. 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?
VAS on pain movement, WOMAC A 1.1 section. 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 4 Mar 2010.