Safety of Diclofenac Sodium Gel in Knee Osteoarthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00171691
First received: September 13, 2005
Last updated: April 20, 2012
Last verified: April 2012
  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
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)
  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00171691

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

Additional Information:
No publications provided

Responsible Party: Novartis
ClinicalTrials.gov 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
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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 15, 2014