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

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

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

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.

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:

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

Hide Study Locations

Locations

United States, Alabama
River Region Research, LLC
Tallassee, Alabama, United States, 36078
Coastal Clinical Research Inc
Mobile, Alabama, United States, 33608
United States, Arizona
East Valley Family Physicians
Chandler, Arizona, United States, 85224
HOPE Research Institute
Phoenix, Arizona, United States, 85050
United States, Arkansas
Heartland Research Associates LLC
Arkansas City, Arkansas, United States, 67005
United States, California
Santa Barbara Clinical Research, Inc
Santa Barbara, California, United States, 93108
Universal BioPharma Research, Inc.
Fresno, California, United States, 93703
MED Investigations
Carmichael, California, United States, 95608
MED Investigations, Inc.
Fair Oaks, California, United States, 95628
Lovelace Scientific Research, Inc.
Beverly Hills, California, United States, 92011
Pacific Arthritis Center Medical Group
Santa Maria, California, United States, 93454
United States, Connecticut
Clinical Research Consultants, LLC
Stratford, Connecticut, United States, 06615
United States, Florida
Suncoast Clinical Research, Inc.
New Port Richey, Florida, United States, 34652
Sunshine Research Center, LLC
Opa Locka, Florida, United States, 33056
Coastal Medical Research
Port Orange, Florida, United States, 32127
Sunrise Medical Research
Plantation, Florida, United States, 33324
Radiant Research
Stuart, Florida, United States, 34996
AppleMed Research, Inc.
Miami, Florida, United States, 33155
Florida Medical Research Institute
Gainesville, Florida, United States, 32607
Andres Patron DO PA
Pembroke Pines, Florida, United States, 33028
South Florida Clinical Research Center
Hollywood, Florida, United States, 33023
Radiant Research - St Petersburg
Pinellas Park, Florida, United States, 33781
Seidman Clinical Trials
Delray Beach, Florida, United States, 33484
University Clinical Research, Inc.
Pembroke Pines, Florida, United States, 33024
Health Awareness, Inc.
Jupiter, Florida, United States, 33458
Peninsula Research, Inc.
Ormond Beach, Florida, United States, 32174
Suncoast Internal Medicine Consultants
Largo, Florida, United States, 33774
United States, Idaho
Intermountain Orthopaedics
Boise, Idaho, United States, 83702
United States, Indiana
Medical Specialists Clinical Research Center
Munster, Indiana, United States, 46321
United States, Kansas
Heartland Research Associates, LLC
Newton, Kansas, United States, 67114
Heartland Research Associates, LLC
Wichita, Kansas, United States, 67205
Heartland Research Associates, LLC
Wichita, Kansas, United States, 67205
United States, Louisiana
Best Clinical Trial, LLC
New Orleans, Louisiana, United States, 70115
United States, Maryland
The Center for Rheumatology and Bone Research
Wheaton, Maryland, United States, 20902
Peter A. Holt, MD
Baltimore, Maryland, United States, 21239
United States, Massachusetts
Phase III Clinical Research
Fall River, Massachusetts, United States, 02720
United States, Michigan
Professional Clinical Research, Inc
Cadillac, Michigan, United States, 49601
United States, Minnesota
Twin Cities Clinical Research
Brooklyn Center, Minnesota, United States, 55430
United States, Missouri
St. Louis Center for Clinical Research
St. Louis, Missouri, United States, 63128
The Center for Pharmaceutical Research
Kansas City, Missouri, United States, 64114
United States, Nebraska
Internal Medical Associates
Grand Island, Nebraska, United States, 68803
United States, New Jersey
South Jersey Medical Associates, PA
Blackwood, New Jersey, United States, 08012
United States, North Carolina
North Carolina Arthritis & Allergy Care Center
Raleigh, North Carolina, United States, 27609
United States, Ohio
Rapid Medical Research, Inc
Cleveland, Ohio, United States, 44122
Clinical Research Source, Inc
Perrysburg, Ohio, United States, 43551
Radiant Research, Inc. - Akron
Mogadore, Ohio, United States, 44260
Radiant Research
Columbus, Ohio, United States, 43212
United States, Pennsylvania
Southeastern Pennsylvania Medical Institute
Havertown, Pennsylvania, United States, 19083
Radiant Research
Philadelphia, Pennsylvania, United States, 19115
Feasterville Family Health Care Center
Feasterville, Pennsylvania, United States, 19053
Neshaminy Medical, PC
Bensalem, Pennsylvania, United States, 19020
Westminster Family Medicine
Erie, Pennsylvania, United States, 16506
United States, Rhode Island
Omega Medical Research
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Radiant Research - Anderson
Anderson, South Carolina, United States, 29621
United States, Tennessee
Holston Medical Group
Kingsport, Tennessee, United States, 37660
United States, Texas
Walter F. Chase, M.D., P.A.
Austin, Texas, United States, 78705
Quality Research, Inc.
San Antonio, Texas, United States, 78209
Radiant Research - San Antonio
San Antonio, Texas, United States, 78229
Texas Research Center, LLP
Sugar Land, Texas, United States, 77479
Radiant Research Dallas North
Dallas, Texas, United States, 75231
Amarillo Center for Clinical Research
Amarillo, Texas, United States, 79124
United States, Virginia
Health Research of Hampton Roads, Inc.
Newport News, Virginia, United States, 23606
Tidewater Integrated Medical Research
Virginia Beach, Virginia, United States, 23451
United States, Washington
The Physicians Clinic of Spokane
Spokane, Washington, United States, 99204
United States, Wisconsin
Advanced Healthcare
Milwaukee, Wisconsin, United States, 53209

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

Roy Altman, MD

University of California, in Los Angeles, Division of Rheumatology, 310 206 7866

More Information

No publications provided

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

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Osteoarthritis
Joint Diseases
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Diclofenac
Enzyme Inhibitors
Rheumatic Diseases
Pharmacologic Actions
Osteoarthritis, Knee

Musculoskeletal Diseases
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Arthritis
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009