Status:
UNKNOWN
Evaluation of a New Formulation Useful for the Osteoarthrosis Treatment
Lead Sponsor:
Nucitec
Collaborating Sponsors:
National Council of Science and Technology, Mexico
Conditions:
Osteoarthritis
Eligibility:
All Genders
40+ years
Phase:
PHASE2
PHASE3
Brief Summary
Abstract Kondrium, is a pharmaceutical composition for the treatment of osteoarthritis (OA). This study was designed to evaluate the efficacy and safety of kondrium in the treatment of OA of knee. A...
Detailed Description
The WOMAC osteoarthritis index is a validated, multidimensional, disease specific, health status measure. It probes clinically important patient relevant symptoms in the areas of pain, stiffness and p...
Eligibility Criteria
Inclusion
- age \> 40 years
- symptomatic evidence of OA in the knee for at least 1 year
- radiographic evidence of Kellgren and Lawrence grade II to IV OA of the knee
- no intra-articular injection of corticosteroids within the last 3 months
Exclusion
- any history of adverse reaction to the study drugs
- current pregnancy status
- uncontrolled hypertension
- active infection
- undergone surgery/arthroscopy within three months
- diagnosis of radiographic OA of Kellgren and Lawrence grade I
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT00977444
Start Date
November 1 2007
End Date
October 1 2009
Last Update
January 20 2010
Active Locations (1)
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1
Hospital San Jose
Querétaro City, Querétaro, Mexico