Safety of Diclofenac Sodium Gel in Knee Osteoarthritis

This study has been completed.
Information provided by (Responsible Party):
Novartis Identifier:
First received: September 13, 2005
Last updated: April 20, 2012
Last verified: April 2012
This study will test the efficacy and safety of topical Voltaren in the treatment of knee osteoarthritis.

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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)

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00171691

United States, New Jersey
Novartis Consumer Health Inc.
Parsippany, New Jersey, United States
Sponsors and Collaborators
  More Information

Additional Information:
Responsible Party: Novartis Identifier: NCT00171691     History of Changes
Other Study ID Numbers: VOSG-PN-309 
Study First Received: September 13, 2005
Last Updated: April 20, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents processed this record on May 26, 2016