Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00171626

First Posted: September 15, 2005

Last Update Posted: April 23, 2012

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.

Information provided by (Responsible Party):

Novartis

Purpose

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

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


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment
Official Title:	Efficacy and 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:

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:	August 2004
Study Completion Date:	June 2005
Primary Completion Date:	June 2005 (Final data collection date for primary outcome measure)

Eligibility

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:

Novartis Clinical Trial Results Database This link exits the ClinicalTrials.gov site

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

Baraf HS, Gloth FM, Barthel HR, Gold MS, Altman RD. Safety and efficacy of topical diclofenac sodium gel for knee osteoarthritis in elderly and younger patients: pooled data from three randomized, double-blind, parallel-group, placebo-controlled, multicentre trials. Drugs Aging. 2011 Jan 1;28(1):27-40. doi: 10.2165/11584880-000000000-00000.


Responsible Party:	Novartis
ClinicalTrials.gov Identifier:	NCT00171626 History of Changes
Other Study ID Numbers:	VOSG-PN-304
First Submitted:	September 13, 2005
First Posted:	September 15, 2005
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

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