NSAID Treatment in Knee Osteoarthritis

NCT01860833 | Completed Phase 4 DMC

• 1 other identifier: LGOG1
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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.

  0-14 days

Secondary Outcomes (1)

• Naranjo probability scale

  14 days

Study Arms (6)

diclofenac 75 mg/day

ACTIVE COMPARATOR

diclofenac 75 mg once day slow release

Drug: Diclofenac

diclofenac 150 mg/day

ACTIVE COMPARATOR

diclofenac 75 mg bid

Drug: Diclofenac

ibuprofen 1200 mg/day

ACTIVE COMPARATOR

ibuprofen 600 mg bid

Drug: Ibuprofen

ibuprofen 1800 mg/day

ACTIVE COMPARATOR

ibuprofen 600 mg tid

Drug: Ibuprofen

celecoxib 200 mg/day

ACTIVE COMPARATOR

celecoxib 200 mg once day

Drug: Celecoxib

celecoxib 400 mg/day

ACTIVE COMPARATOR

celecoxib 200 mg bid

Drug: Celecoxib

Interventions

Ibuprofen DRUG

time of treatment 14 days

Also known as: Brufen

ibuprofen 1200 mg/day; ibuprofen 1800 mg/day

Celecoxib DRUG

time of treatment 14 days

Also known as: celebrex

celecoxib 200 mg/day; celecoxib 400 mg/day

Diclofenac DRUG

time of treatment 14 days

Also known as: voltaren

diclofenac 150 mg/day; diclofenac 75 mg/day

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• clinical signs of joint inflammation (warmth, swelling or effusion) and
• a disease severity grade 2 or 3 according to the Kellgren-Lawrence classification

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Catanzaro: lead

Study Sites (1)

Department of Orthopedic and Trauma Surgery

Catanzaro, 88100, Italy

Location

Related Publications (1)

• 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.

  PMID: 23973155 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Ibuprofen; Celecoxib; Diclofenac

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzenesulfonamides; Sulfonamides; Amides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenylacetates

Study Officials

• Luca Gallelli, MD

  University of Catanzaro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 20, 2013
• First Posted: May 23, 2013
• Study Start: April 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: May 23, 2013

Record last verified: 2013-05

Locations

IT (1)