Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov 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 diclofenac sodium gel in the treatment of knee osteoarthritis.

Condition Intervention Phase
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:

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)

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00171626

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

Additional Information:
No publications provided by Novartis

Additional 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, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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 21, 2014