Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
90 participants
INTERVENTIONAL
2010-04-30
2011-08-31
Brief Summary
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Certain therapies that specifically interfere with the expression or actions of pro-inflammatory cytokines have been explored. NSAIDs have analgesic, antipyretic and anti-inflammatory properties and are extensively prescribed for several musculoskeletal disorders. Indeed, the Osteoarthritis Research Society International (OARSI) recently recommended the use of NSAIDs for management of knee and hip OA in symptomatic patients. These drugs have been shown to influence cytokine metabolism in the synovial fluid of OA patients with satisfactory relief of painful osteoarthritic joints.
The aim of the current study was to explore whether NSAID treatment inhibits TNF-alpha, IL-6, IL-8, and VEGF secretion in the synovial fluid of osteoarthritic joints. In particular, diclofenac, ibuprofen and celecoxib were studied. Under the hypothesis that relationships between proinflammatory cytokines and the clinical status of OA patients are possible, we also evaluated the association between the concentration of these molecules in the osteoarthritic knee synovial fluid and the pain and functional status of patients with OA. The effects of NSAIDS on signal transduction pathways in the synovial membrane were also investigated.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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diclofenac 75 mg/day
diclofenac 75 mg once day slow release
Diclofenac
time of treatment 14 days
diclofenac 150 mg/day
diclofenac 75 mg bid
Diclofenac
time of treatment 14 days
ibuprofen 1200 mg/day
ibuprofen 600 mg bid
Ibuprofen
time of treatment 14 days
ibuprofen 1800 mg/day
ibuprofen 600 mg tid
Ibuprofen
time of treatment 14 days
celecoxib 200 mg/day
celecoxib 200 mg once day
Celecoxib
time of treatment 14 days
celecoxib 400 mg/day
celecoxib 200 mg bid
Celecoxib
time of treatment 14 days
Interventions
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Ibuprofen
time of treatment 14 days
Celecoxib
time of treatment 14 days
Diclofenac
time of treatment 14 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* older than 50 years and
* had primary knee OA diagnosed according to the clinical and radiological criteria of the American Rheumatism Association.
* clinical signs of joint inflammation (warmth, swelling or effusion) and
* a disease severity grade 2 or 3 according to the Kellgren-Lawrence classification
Exclusion Criteria
* 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).
50 Years
85 Years
ALL
No
Sponsors
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University of Catanzaro
OTHER
Responsible Party
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Luca Gallelli
MD
Principal Investigators
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Luca Gallelli, MD
Role: PRINCIPAL_INVESTIGATOR
University of Catanzaro
Locations
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Department of Orthopedic and Trauma Surgery
Catanzaro, , Italy
Countries
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References
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Gallelli L, Galasso O, Falcone D, Southworth S, Greco M, Ventura V, Romualdi P, Corigliano A, Terracciano R, Savino R, Gulletta E, Gasparini G, De Sarro G. The effects of nonsteroidal anti-inflammatory drugs on clinical outcomes, synovial fluid cytokine concentration and signal transduction pathways in knee osteoarthritis. A randomized open label trial. Osteoarthritis Cartilage. 2013 Sep;21(9):1400-8. doi: 10.1016/j.joca.2013.06.026.
Other Identifiers
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LGOG1
Identifier Type: -
Identifier Source: org_study_id
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