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Safety of Diclofenac Sodium Gel in Knee Osteoarthritis

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: NCT00171691
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : April 23, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis

Study Description
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Brief Summary:
This study will test the efficacy and safety of topical Voltaren in the treatment of knee osteoarthritis.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Diclofenac Topical Sodium Gel 1% Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 450 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety of Diclofenac Sodium Gel in Knee Osteoarthritis
Study Start Date : October 2004
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Incidence of treatment-emergent adverse events
  2. Number of laboratory values outside pre-determined ranges at Months 1, 3, 6, 9 and 12

Secondary Outcome Measures :
  1. Incidence of serious treatment-emergent adverse events
  2. Number of patients who discontinued study medication due to a treatment-emergent adverse event
  3. WOMAC pain, physical function and stiffness scores at Months 3, 6, 9 and 12

Eligibility Criteria
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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion criteria

• Osteoarthritis 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
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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): NCT00171691


Locations
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United States, New Jersey
Novartis Consumer Health Inc.
Parsippany, New Jersey, United States
Sponsors and Collaborators
Novartis
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00171691    
Other Study ID Numbers: VOSG-PN-309
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: April 23, 2012
Last Verified: April 2012
Keywords provided by Novartis:
Knee osteoarthritis, Topical NSAID, Diclofenac sodium
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
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