Hip OsteoarthritisPhase 3ECHODIAHNCT00451360
Chondromodulating Effect of Diacerein in Osteoarthritis of the Hip
A Phase 3 study testing diacerein in people with Hip Osteoarthritis, run by Laboratoires NEGMA at 25 sites in France.
Trial summary
We carried out a 3 years, randomized, double-blind, placebo-controlled, multicenter clinical trial in patients with hip osteoarthritis in order to: evaluate the ability of diacerein, an interleukin-1β inhibitor, to slow the progressive decrease in joint space width observed in patients with hip osteoarthritis to… Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- diacerein
- How many people
- 500 participants
- Where
- 25 sitesFrance
- Study dates
- Mar 1993to Apr 1997
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients fulfilling the American College of Rheumatology criteria for the diagnosis of hip osteoarthritis.
- Lequesne algofunctional index of at list 3 points.
- Radiographic criterion for inclusion: joint space width (JSW) between 1 mm and 3 mm. If the JSW exceeded 3 mm, it had to be at least 0.5 mm thinner than JSW of the contra lateral hip, measured at its narrowest point.
Who cannot join
- Intraarticular injection or arthroscopy of the hip during the three months prior to inclusion in the study.
- Any systemic or intraarticular corticosteroid as well as other potential symptom-modifying drugs for osteoarthritis were not allowed during the study.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
France25 sites
Hôpital Nord
Amiens, 80030
Hôpital Pellegrin
Bordeaux, 33076
Hôpital Ambroise Paré
Boulogne, 92100
CHU cote de Nacre
Caen, 14033
Hôpital Mondor
Créteil, 94000
Hôpital Général
Dijon, 21000
CHU
Grenoble, 38043
Hôpital Roger Salengro
Lille, 59037
CHRU Dupuytren
Limoges, 87042
Hôpital de la Timone
Marseille, 13 385
Hôpital Lapeyronie
Montpellier, 34295
Hôpital de l'Archet
Nice, 6202
Hôpital Cochin, clinique de rhumatologie
Paris, 74014
Study site
Paris, 75011
Hôpital Cochin
Paris, 75014
Hôpital Leopold Bellan
Paris, 75674
CH Lyon Sud
Pierre-Bénite, 69495
CHU Lyon Sud
Pierre-Bénite, 69495
Hôpital de la Milétrie
Poitiers, 86 021
CHR
Rennes, 35000
Hôpitam de Bois Guillaume
Rouen, 76031
Hôpital de Hautepierre
Strasbourg, 67098
CHU de Rangueil
Toulouse, 31403
CHU Trousseau
Tours, 37044
CHU de Brabois
Vandœuvre-lès-Nancy, 54511
About this study
Official title: Evaluation of the CHOndromodulating Effect of DIAcerein in Osteoarthritis of the Hip. ECHODIAH.
We carried out a 3 years, randomized, double-blind, placebo-controlled, multicenter clinical trial in patients with hip osteoarthritis in order to:
- evaluate the ability of diacerein, an interleukin-1β inhibitor, to slow the progressive decrease in joint space width observed in patients with hip osteoarthritis
- to investigate the potential structure-modifying effect of diacerein in patients with hip osteoarthritis
This study compare also after ten years the percentage of patients in each treatment group who require a hip replacement surgery
- Conditions
- Hip Osteoarthritis
- Being tested
- diacerein
- Keywords
- Diacerein, Hip osteoarthritis, Structure-modifying effect / Chondromodulating effect, Double blind study
- Medical subject headings
- Osteoarthritis, Hip
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.
Joint space measurement
Secondary outcomes (2)
Requirement of hip replacement surgery after ten years
Tolerability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2007 (estimated)
- Study startMar 1993
- Study completionApr 1997
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 Hip 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 3
- 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
- DOUGADOS Maxime, Principal investigator, Scientific committeeMichel LEQUESNE, Principal investigator, Scientific committeeBernard MAZIERE, Principal investigator, Scientific committeeEric VIGNON, Principal investigator, Scientific committeeLaurent BERDAH, Principal investigator, Scientific committeeMinh NGUYEN, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00451360
- Sponsor's protocol ID
- HEC / CHO 90040N
- Other IDs
- AFSSAPS number: 930289, CCPPRB number: 469
- Acronym
- ECHODIAH
- Status last verified
- Mar 2007
- First submitted
- 22 Mar 2007
- Last updated
- 25 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Dougados M, Nguyen M, Berdah L, Mazieres B, Vignon E, Lequesne M; ECHODIAH Investigators Study Group. Evaluation of the structure-modifying effects of diacerein in hip osteoarthritis: ECHODIAH, a three-year, placebo-controlled trial. Evaluation of the Chondromodulating Effect of Diacerein in OA of the Hip. Arthritis Rheum. 2001 Nov;44(11):2539-47. doi: 10.1002/1529-0131(200111)44:113.0.co;2-t.
PubMed 11710710
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the CHOndromodulating Effect of DIAcerein in Osteoarthritis of the Hip. ECHODIAH.
- ClinicalTrials.gov ID
- NCT00451360
- Acronym / sponsor ID
- ECHODIAH / HEC / CHO 90040N
- Conditions
- Hip Osteoarthritis
- Keywords
- Diacerein, Hip osteoarthritis, Structure-modifying effect / Chondromodulating effect, Double blind study
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- Laboratoires NEGMAIndustry (pharma, biotech, devices)
- Study start
- Mar 1993
- Study completion
- Apr 1997 (actual)
- First posted
- 23 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.
We carried out a 3 years, randomized, double-blind, placebo-controlled, multicenter clinical trial in patients with hip osteoarthritis in order to:
- evaluate the ability of diacerein, an interleukin-1β inhibitor, to slow the progressive decrease in joint space width observed in patients with hip osteoarthritis
- to investigate the potential structure-modifying effect of diacerein in patients with hip osteoarthritis
This study compare also after ten years the percentage of patients in each treatment group who require a hip replacement surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Outpatients fulfilling the American College of Rheumatology criteria for the diagnosis of hip osteoarthritis.
- Lequesne algofunctional index of at list 3 points.
- Radiographic criterion for inclusion: joint space width (JSW) between 1 mm and 3 mm. If the JSW exceeded 3 mm, it had to be at least 0.5 mm thinner than JSW of the contra lateral hip, measured at its narrowest point.
Key exclusion criteria (2 listed)
- Intraarticular injection or arthroscopy of the hip during the three months prior to inclusion in the study.
- Any systemic or intraarticular corticosteroid as well as other potential symptom-modifying drugs for osteoarthritis were not allowed during the study.
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
Joint space measurement
2 secondary outcomes
Requirement of hip replacement surgery after ten years
Tolerability
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 25 Jul 2008.
- Results publication: PubMed 11710710Dougados M, Nguyen M, Berdah L, Mazieres B, Vignon E, Lequesne M; ECHODIAH Investigators Study Group. Evaluation of the structure-modifying effects of diacerein in hip osteoarthritis: ECHODIAH, a three-year, placebo-controlled trial. Evaluation of the Chondromodulating Effect of Diacerein in OA of the Hip. Arthritis Rheum. 2001 Nov;44(11):2539-47. doi: 10.1002/1529-0131(200111)44:113.0.co;2-t.
Related trials for Hip Osteoarthritis
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
Recruiting
Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
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Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
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.
DOUGADOS Maxime principal investigator
Scientific committee
Michel LEQUESNE principal investigator
Scientific committee
Bernard MAZIERE principal investigator
Scientific committee
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing diacerein in people with Hip Osteoarthritis, run by Laboratoires NEGMA at 25 sites 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 2 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 25 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites 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 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?
Joint space measurement. 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 NCT00451360, 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 25 Jul 2008.