Status:
COMPLETED
NSAID Treatment in Knee Osteoarthritis
Lead Sponsor:
University of Catanzaro
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
50-85 years
Phase:
PHASE4
Brief Summary
Central mechanisms may play a role in pain perception during osteoarthritis (OA).Local inflammation (which involves production of pro-inflammatory cytokines such as interleukin (IL) 4 TNF-alpha, IL-6 ...
Detailed Description
not desired
Eligibility Criteria
Inclusion
- Patients eligible for the study were:
- older than 50 years and
- had primary knee OA diagnosed according to the clinical and radiological criteria of the American Rheumatism Association.
- Further inclusion criteria were:
- clinical signs of joint inflammation (warmth, swelling or effusion) and
- a disease severity grade 2 or 3 according to the Kellgren-Lawrence classification
Exclusion
- allergy to NSAIDs,
- progressive serious medical conditions (such as cancer, AIDS or end-stage renal disease),
- history of gastrointestinal ulcer or bleeding,
- a hemoglobin concentration lower than 11.5 g/dL,
- renal diseases (serum creatinine concentration more than 1.2 times the upper limit of the normal range according to the central laboratory definition reference values), or
- liver dysfunction (serum alanine or aspartate transaminase concentrations more than 1.5 times the upper limit of normal range according to the central laboratory definition reference values).
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01860833
Start Date
April 1 2010
End Date
August 1 2011
Last Update
May 23 2013
Active Locations (1)
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1
Department of Orthopedic and Trauma Surgery
Catanzaro, Italy, 88100