Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis - Full Text View

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 III

MedlinePlus related topics:

Osteoarthritis

ChemIDplus related topics:

Diclofenac Diclofenac potassium Diclofenac sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Efficacy and Safety of Diclofenac Sodium Gel in Knee Osteoarthritis

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

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

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

Study ID Numbers:	VOSG-PN-310
First Received:	September 13, 2005
Last Updated:	May 29, 2006
ClinicalTrials.gov Identifier:	NCT00171678
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Knee osteoarthritis, Topical NSAID, Diclofenac sodium

Study placed in the following topic categories:

Osteoarthritis, Knee

Musculoskeletal Diseases

Osteoarthritis

Joint Diseases

Arthritis

Diclofenac

Rheumatic Diseases

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Cyclooxygenase Inhibitors

Enzyme Inhibitors

Pharmacologic Actions

Analgesics, Non-Narcotic

Sensory System Agents

Therapeutic Uses

Anti-Inflammatory Agents, Non-Steroidal

Analgesics

Peripheral Nervous System Agents

Antirheumatic Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00171678