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Safety of Diclofenac Sodium Gel in Knee Osteoarthritis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00171691
First Posted: September 15, 2005
Last Update Posted: April 23, 2012
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.
Information provided by (Responsible Party):
Novartis
  Purpose
This study will test the efficacy and safety of topical Voltaren in the treatment of knee osteoarthritis.

Condition Intervention Phase
Osteoarthritis Drug: Diclofenac Topical Sodium Gel 1% Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

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

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

Estimated Enrollment: 450
Study Start Date: October 2004
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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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
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

Additional Information:
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 Submitted: September 13, 2005
First Posted: September 15, 2005
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