OsteoarthritisPhase 4NCT00440661
Exploration of the Synovial Fluid Inflammation Mediators Under Diacerhein in Knee Osteoarthritis
A Phase 4 study testing Diacerhein in people with Osteoarthritis, run by Laboratoires NEGMA at 1 site in Canada.
Trial summary
Some inflammation mediators, notably IL-1, are implied in the joint degeneration phenomena of osteoarthritis. The aim of this study is to confirm in vivo the favourable effect of diacerhein on IL-1 and also to appreciate its effect on other synovial inflammation mediators. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Diacerhein
- How many people
- 96 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2007to Oct 2008
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Painful osteoarthritis
- Hydarthrosis (synovial effusion)
Who cannot join
- large effusion
- severe pathologies
- anti-osteoarthritic treatments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploratory Study of Some Synovial Fluid Inflammation Mediatorsunder Diacerhein in Knee Osteoarthritis Patients. Phase IV Study.
Some inflammation mediators, notably IL-1, are implied in the joint degeneration phenomena of osteoarthritis. The aim of this study is to confirm in vivo the favourable effect of diacerhein on IL-1 and also to appreciate its effect on other synovial inflammation mediators.
- Conditions
- Osteoarthritis
- Being tested
- Diacerhein
- Keywords
- Osteoarthritis, IL-1
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiacerheinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Synovial concentration of IL-1
Secondary outcomes (2)
Synovial concentration of IL-6
WOMAC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2007 (estimated)
- Study startMar 2007
- Primary completionOct 2008
- Study completionOct 2008
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratoires NEGMA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jean-Pierre RAYNAULD, MD, Principal investigator, Institut de Rhumatologie de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00440661
- Sponsor's protocol ID
- HEC/ART06572N
- Other IDs
- 109196
- Status last verified
- Oct 2007
- First submitted
- 26 Feb 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
- Exploratory Study of Some Synovial Fluid Inflammation Mediatorsunder Diacerhein in Knee Osteoarthritis Patients. Phase IV Study.
- ClinicalTrials.gov ID
- NCT00440661
- Acronym / sponsor ID
- HEC/ART06572N
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, IL-1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Laboratoires NEGMAIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 27 Feb 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.
Some inflammation mediators, notably IL-1, are implied in the joint degeneration phenomena of osteoarthritis. The aim of this study is to confirm in vivo the favourable effect of diacerhein on IL-1 and also to appreciate its effect on other synovial inflammation mediators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Painful osteoarthritis
- Hydarthrosis (synovial effusion)
Key exclusion criteria (3 listed)
- large effusion
- severe pathologies
- anti-osteoarthritic treatments
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 |
|---|---|---|
| Diacerhein | Drug | – |
Primary outcome
Synovial concentration of IL-1
2 secondary outcomes
Synovial concentration of IL-6
WOMAC
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.
Related trials for Osteoarthritis
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Holistic Healing for Knee Osteoarthritis
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Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Effect of Anti-inflammatory Diet in Osteoarthritis
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Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
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 RAYNAULD, MD principal investigator
Institut de Rhumatologie de Montreal
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 Diacerhein in people with Osteoarthritis, run by Laboratoires NEGMA at 1 site in Canada.
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 2 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 Canada. 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?
Synovial concentration of IL-1. 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.