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Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00171626
First received: September 13, 2005
Last updated: April 20, 2012
Last verified: April 2012
History of Changes
  Purpose
This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of knee osteoarthritis.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • WOMAC pain score in target knee at Week 12
  • WOMAC physical function score in target knee at Week 12
  • Global rating of disease activity by patient at Week 12

Secondary Outcome Measures:
  • WOMAC pain and physical function scores in target knee and global rating of disease activity by patient at Weeks 1, 4 and 8
  • WOMAC stiffness score, pain on movement and spontaneous pain in target knee, and global rating of benefit by patient, at Weeks 1, 4, 8 and 12
  • Pain on movement in target knee and use of rescue medication recorded in diary
  • Global evaluation of treatment at final visit
  • Treatment responder rate according to OARSI criteria
Estimated Enrollment: 480
Study Start Date: August 2004
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
  Eligibility
Ages Eligible for Study:   35 Years and older   (Adult, Senior)
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
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 ClinicalTrials.gov identifier: NCT00171626

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

Additional Information:
Novartis Clinical Trial 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: NCT00171626     History of Changes
Other Study ID Numbers: VOSG-PN-304 
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
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 27, 2016