Efficacy and Safety of Diclofenac Sodium Gel (DSG) 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
Osteoarthritis of the Knee	Drug: Diclofenac Sodium Gel Drug: Placebo	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 (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

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.

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
1: Experimental	Drug: Diclofenac Sodium Gel 4 grams per knee, 4 times per day, for 12 weeks
2: Placebo Comparator	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 65 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

Responsible Party:	University of California, in Los Angeles, Division of Rheumatology, ( Roy Altman )
Study ID Numbers:	VOSG-PN-316
First Received:	January 24, 2007
Last Updated:	December 13, 2007
ClinicalTrials.gov Identifier:	NCT00426621
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

Study placed in the following topic categories:

Signs and Symptoms

Osteoarthritis, Knee

Musculoskeletal Diseases

Osteoarthritis

Arthritis

Joint Diseases

Diclofenac

Pain

Rheumatic Diseases

Arthralgia

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 23, 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00426621