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Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis

This study has been completed.

Sponsored by: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00171678
  Purpose

This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of knee osteoarthritis.


Condition Intervention Phase
Osteearthritis
Drug: Diclofenac Topical Sodium Gel 1%
Phase III

MedlinePlus related topics:   Osteoarthritis   

ChemIDplus related topics:   Diclofenac    Diclofenac potassium    Diclofenac sodium   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis

Further study details as provided by Novartis:

Primary Outcome Measures:
  • WOMAC pain score in target knee at Week 12
  • WOMAC physical function score in target knee at Week 12
  • Global rating of disease activity by patient at Week 12

Secondary Outcome Measures:
  • WOMAC pain and physical function scores in target knee and global rating of disease activity by patient at Weeks 1, 4 and 8
  • WOMAC stiffness score, pain on movement and spontaneous pain in target knee, and global rating of benefit by patient, at Weeks 1, 4, 8 and 12
  • Pain on movement in target knee and use of rescue medication recorded in diary
  • Global evaluation of treatment at final visit
  • Treatment responder rate according to OARSI criteria

Estimated Enrollment:   480

  Eligibility
Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Key Inclusion criteria

  • OA of the knee Key Exclusion criteria
  • Other rheumatic disease, such as rheumatoid arthritis
  • Active gastrointestinal ulcer during the last year
  • Known allergy to analgesic drugs
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00171678

Locations
United States, New Jersey
Novartis Consumer Health Inc.    
      Parsippany, New Jersey, United States

Sponsors and Collaborators
Novartis
  More Information

Study ID Numbers:   VOSG-PN-310
First Received:   September 13, 2005
Last Updated:   May 29, 2006
ClinicalTrials.gov Identifier:   NCT00171678
Health Authority:   United States: Food and Drug Administration

Keywords provided by Novartis:
Knee osteoarthritis, Topical NSAID, Diclofenac sodium  

Study placed in the following topic categories:
Osteoarthritis, Knee
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Diclofenac
Rheumatic Diseases

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 05, 2008




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