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Safety of Diclofenac Sodium Gel in Knee Osteoarthritis

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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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   35 Years and older   (Adult, Senior)
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
United States, New Jersey
Novartis Consumer Health Inc.
Parsippany, New Jersey, United States
Sponsors and Collaborators
Novartis
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Novartis Clinical Trials Results database  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00171691     History of Changes
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:
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