Safety of Diclofenac Sodium Gel in Knee Osteoarthritis

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis

ClinicalTrials.gov Identifier:

NCT00171691

First received: September 13, 2005

Last updated: April 20, 2012

Last verified: April 2012

History of Changes

Purpose

This study will test the efficacy and safety of topical Voltaren in the treatment of knee osteoarthritis.

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


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Safety of Diclofenac Sodium Gel in Knee Osteoarthritis

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Diclofenac sodium Diclofenac potassium Diclofenac

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Incidence of treatment-emergent adverse events
Number of laboratory values outside pre-determined ranges at Months 1, 3, 6, 9 and 12

Secondary Outcome Measures:

Incidence of serious treatment-emergent adverse events
Number of patients who discontinued study medication due to a treatment-emergent adverse event
WOMAC pain, physical function and stiffness scores at Months 3, 6, 9 and 12


Estimated Enrollment:	450
Study Start Date:	October 2004
Study Completion Date:	June 2006
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Eligibility


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

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: NCT00171691

Locations


United States, New Jersey
Novartis Consumer Health Inc.
Parsippany, New Jersey, United States

Sponsors and Collaborators

Novartis

More Information

Additional Information:

Novartis Clinical Trials Results database This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Peniston JH, Gold MS, Alwine LK. An open-label, long-term safety and tolerability trial of diclofenac sodium 1% gel in patients with knee osteoarthritis. Phys Sportsmed. 2011 Sep;39(3):31-8. doi: 10.3810/psm.2011.09.1918.


Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00171691 History of Changes
Other Study ID Numbers:	VOSG-PN-309
Study First Received:	September 13, 2005
Last Updated:	April 20, 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

ClinicalTrials.gov processed this record on September 21, 2017

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