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Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis

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.
ClinicalTrials.gov Identifier: NCT00171626
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : April 23, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of knee osteoarthritis.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Diclofenac Topical Sodium Gel 1% Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis
Study Start Date : August 2004
Primary Completion Date : June 2005
Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

Secondary Outcome Measures :
  1. WOMAC pain and physical function scores in target knee and global rating of disease activity by patient at Weeks 1, 4 and 8
  2. 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
  3. Pain on movement in target knee and use of rescue medication recorded in diary
  4. Global evaluation of treatment at final visit
  5. Treatment responder rate according to OARSI criteria

Eligibility Criteria

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): NCT00171626


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: NCT00171626     History of Changes
Other Study ID Numbers: VOSG-PN-304
First Posted: September 15, 2005    Key Record Dates
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