NSAID Treatment in Knee Osteoarthritis (NSKO)
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Ibuprofen
Celecoxib
Diclofenac
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee Osteoarthritis
Eligibility 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).
Sites / Locations
- Department of Orthopedic and Trauma Surgery
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
diclofenac 75 mg/day
diclofenac 150 mg/day
ibuprofen 1200 mg/day
ibuprofen 1800 mg/day
celecoxib 200 mg/day
celecoxib 400 mg/day
Arm Description
diclofenac 75 mg once day slow release
diclofenac 75 mg bid
ibuprofen 600 mg bid
ibuprofen 600 mg tid
celecoxib 200 mg once day
celecoxib 200 mg bid
Outcomes
Primary Outcome Measures
Western Ontario and McMaster universities (WOMAC) osteoarthritis index score
Womac was used to 77 measure the disease-specific health status of patients before and after the pharmacological treatment.
Secondary Outcome Measures
Naranjo probability scale
The Naranjo probability scale was used to evaluate the development of adverse drug reaction during this study
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01860833
Brief Title
NSAID Treatment in Knee Osteoarthritis
Acronym
NSKO
Official Title
EFFECTS OF NSAIDs ON CLINICAL OUTCOMES, SYNOVIAL FLUID CYTOKINE CONCENTRATION AND SIGNAL TRANSDUCTION PATHWAYS IN KNEE OSTEOARTHRITIS
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Catanzaro
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
not desired
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
diclofenac 75 mg/day
Arm Type
Active Comparator
Arm Description
diclofenac 75 mg once day slow release
Arm Title
diclofenac 150 mg/day
Arm Type
Active Comparator
Arm Description
diclofenac 75 mg bid
Arm Title
ibuprofen 1200 mg/day
Arm Type
Active Comparator
Arm Description
ibuprofen 600 mg bid
Arm Title
ibuprofen 1800 mg/day
Arm Type
Active Comparator
Arm Description
ibuprofen 600 mg tid
Arm Title
celecoxib 200 mg/day
Arm Type
Active Comparator
Arm Description
celecoxib 200 mg once day
Arm Title
celecoxib 400 mg/day
Arm Type
Active Comparator
Arm Description
celecoxib 200 mg bid
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Other Intervention Name(s)
Brufen
Intervention Description
time of treatment 14 days
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Other Intervention Name(s)
celebrex
Intervention Description
time of treatment 14 days
Intervention Type
Drug
Intervention Name(s)
Diclofenac
Other Intervention Name(s)
voltaren
Intervention Description
time of treatment 14 days
Primary Outcome Measure Information:
Title
Western Ontario and McMaster universities (WOMAC) osteoarthritis index score
Description
Womac was used to 77 measure the disease-specific health status of patients before and after the pharmacological treatment.
Time Frame
0-14 days
Secondary Outcome Measure Information:
Title
Naranjo probability scale
Description
The Naranjo probability scale was used to evaluate the development of adverse drug reaction during this study
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luca Gallelli, MD
Organizational Affiliation
University of Catanzaro
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Orthopedic and Trauma Surgery
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
23973155
Citation
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.
Results Reference
derived
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NSAID Treatment in Knee Osteoarthritis
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