ClinicalTrials.gov
ClinicalTrials.gov Menu

NSAID Treatment in Knee Osteoarthritis (NSKO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01860833
Recruitment Status : Completed
First Posted : May 23, 2013
Last Update Posted : May 23, 2013
Sponsor:
Information provided by (Responsible Party):
Luca Gallelli, University of Cantanzaro

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 and IL-8) is considered to be a major source of pain.

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.


Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: Ibuprofen Drug: Celecoxib Drug: Diclofenac Phase 4

Detailed Description:
not desired

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EFFECTS OF NSAIDs ON CLINICAL OUTCOMES, SYNOVIAL FLUID CYTOKINE CONCENTRATION AND SIGNAL TRANSDUCTION PATHWAYS IN KNEE OSTEOARTHRITIS
Study Start Date : April 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Active Comparator: diclofenac 75 mg/day
diclofenac 75 mg once day slow release
Drug: Diclofenac
time of treatment 14 days
Other Name: voltaren

Active Comparator: diclofenac 150 mg/day
diclofenac 75 mg bid
Drug: Diclofenac
time of treatment 14 days
Other Name: voltaren

Active Comparator: ibuprofen 1200 mg/day
ibuprofen 600 mg bid
Drug: Ibuprofen
time of treatment 14 days
Other Name: Brufen

Active Comparator: ibuprofen 1800 mg/day
ibuprofen 600 mg tid
Drug: Ibuprofen
time of treatment 14 days
Other Name: Brufen

Active Comparator: celecoxib 200 mg/day
celecoxib 200 mg once day
Drug: Celecoxib
time of treatment 14 days
Other Name: celebrex

Active Comparator: celecoxib 400 mg/day
celecoxib 200 mg bid
Drug: Celecoxib
time of treatment 14 days
Other Name: celebrex




Primary Outcome Measures :
  1. Western Ontario and McMaster universities (WOMAC) osteoarthritis index score [ Time Frame: 0-14 days ]
    Womac was used to 77 measure the disease-specific health status of patients before and after the pharmacological treatment.


Secondary Outcome Measures :
  1. Naranjo probability scale [ Time Frame: 14 days ]
    The Naranjo probability scale was used to evaluate the development of adverse drug reaction during this study



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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 Criteria:

  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01860833


Locations
Italy
Department of Orthopedic and Trauma Surgery
Catanzaro, Italy, 88100
Sponsors and Collaborators
University of Cantanzaro
Investigators
Principal Investigator: Luca Gallelli, MD University of Catanzaro

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Luca Gallelli, MD, University of Cantanzaro
ClinicalTrials.gov Identifier: NCT01860833     History of Changes
Other Study ID Numbers: LGOG1
First Posted: May 23, 2013    Key Record Dates
Last Update Posted: May 23, 2013
Last Verified: May 2013

Keywords provided by Luca Gallelli, University of Cantanzaro:
Knee Osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Ibuprofen
Celecoxib
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors