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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00451360 |
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Date of registration:
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22/03/2007 |
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Primary sponsor: |
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Public title:
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Chondromodulating Effect of Diacerein in Osteoarthritis of the Hip
ECHODIAH |
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Scientific title:
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Evaluation of the CHOndromodulating Effect of DIAcerein in Osteoarthritis of the Hip. ECHODIAH. |
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Date of first enrolment:
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March 1993 |
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Target sample size:
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500 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00451360 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Countries of recruitment
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France
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Contacts
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Name:
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Minh NGUYEN |
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Address:
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Affiliation:
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Name:
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Bernard MAZIERE |
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Address:
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Telephone:
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Email:
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Affiliation:
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Scientific committee |
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Name:
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DOUGADOS Maxime |
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Address:
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Telephone:
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Email:
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Affiliation:
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Scientific committee |
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Name:
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Eric VIGNON |
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Address:
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Telephone:
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Email:
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Affiliation:
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Scientific committee |
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Name:
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Laurent BERDAH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Scientific committee |
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Name:
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Michel LEQUESNE |
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Address:
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Telephone:
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Email:
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Affiliation:
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Scientific committee |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Age minimum:
50 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hip Osteoarthritis
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Intervention(s)
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Drug: diacerein
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Primary Outcome(s)
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Joint space measurement
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Secondary Outcome(s)
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Requirement of hip replacement surgery after ten years
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Tolerability
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Secondary ID(s)
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AFSSAPS number: 930289
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CCPPRB number: 469
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HEC / CHO 90040N
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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