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Efficacy and Safety of Diclofenac Sodium Gel (DSG) in Knee Osteoarthritis

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00426621
First received: January 24, 2007
Last updated: December 13, 2007
Last verified: December 2007
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 of the Knee
 Drug: Diclofenac Sodium Gel
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by Novartis:

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

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

Enrollment: 420
Study Start Date: November 2006
Study Completion Date: June 2007
Arms Assigned Interventions
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

  Eligibility

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

No publications provided by Novartis

Additional 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
Study First Received: January 24, 2007
Last Updated: December 13, 2007
Health Authority: United States: Food and Drug Administration

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
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 May 19, 2013