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:
NCT00171678
First received: September 13, 2005
Last updated: April 20, 2012
Last verified: April 2012
  Purpose

This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of knee osteoarthritis.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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: October 2004
Study Completion Date: August 2005
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion criteria

  • OA 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: NCT00171678

Locations
United States, New Jersey
Novartis Consumer Health Inc.
Parsippany, New Jersey, United States
Sponsors and Collaborators
Novartis
  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: NCT00171678     History of Changes
Other Study ID Numbers: VOSG-PN-310
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
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 September 18, 2014