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Efficacy and Safety of Diclofenac Sodium Gel (DSG) 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: NCT00426621
Recruitment Status : Completed
First Posted : January 25, 2007
Last Update Posted : December 18, 2007
Sponsor:
Information provided by:

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 of the Knee Drug: Diclofenac Sodium Gel Drug: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A 12-Week, Randomized, Double-Blind, Multi-Center, Vehicle-Controlled, Parallel Group Study to Assess the Efficacy and Safety of the Diclofenac Sodium Gel 1% for the Relief of Signs and Symptoms in Patients With Osteoarthritis of the Knee.
Study Start Date : November 2006
Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: Diclofenac Sodium Gel
4 grams per knee, 4 times per day, for 12 weeks
Placebo Comparator: 2 Drug: Placebo
4 grams per knee, 4 times per day, for 12 weeks


Outcome Measures

Primary Outcome Measures :
  1. pain in the target knee (WOMAC pain index);
  2. functional capacity in the target knee (WOMAC function index); and
  3. global rating of benefit (100 mm Visual Analogue Scale, VAS).

Secondary Outcome Measures :
  1. Efficacy of Diclofenac Sodium Gel 1% with regard attainment of:
  2. Low pain intensity in either knee; and
  3. Low functional impairment in either knee.
  4. Safety of Diclofenac Sodium Gel 1% assessed by:
  5. monitoring adverse events; and
  6. laboratory evaluations.

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

Inclusion Criteria:

  • Osteoarthritis of the knee

Exclusion Criteria:

  • Other rheumatic disease, such as rheumatoid arthritis
  • Active gastrointestinal ulcer during the last year
  • Known allergy to analgesic drugs
  • Other protocol defined inclusion/exclusion criteria may apply.
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): NCT00426621


  Show 64 Study Locations
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Roy Altman, MD University of California, in Los Angeles, Division of Rheumatology, 310 206 7866
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Roy Altman, University of California, in Los Angeles, Division of Rheumatology,
ClinicalTrials.gov Identifier: NCT00426621     History of Changes
Other Study ID Numbers: VOSG-PN-316
First Posted: January 25, 2007    Key Record Dates
Last Update Posted: December 18, 2007
Last Verified: December 2007

Keywords provided by Novartis:
Knee osteoarthritis, degenerative joint disease, knee pain, joint pain, 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