Efficacy and Safety of Diclofenac Sodium Gel (DSG) in Knee Osteoarthritis

Osteoarthritis of the Knee Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00426621
• Other study ID #: VOSG-PN-316
• Status: Completed
• Phase: Phase 3
• First received: January 24, 2007
• Last updated: December 13, 2007
• Start date: November 2006
• Est. completion date: June 2007

Study information

• Verified date: December 2007
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Drug:
• Diclofenac Sodium Gel
4 grams per knee, 4 times per day, for 12 weeks
• Placebo
4 grams per knee, 4 times per day, for 12 weeks

Locations

Country	Name	City	State
United States	Amarillo Center for Clinical Research	Amarillo	Texas
United States	Radiant Research - Anderson	Anderson	South Carolina
United States	Heartland Research Associates LLC	Arkansas City	Arkansas
United States	Walter F. Chase, M.D., P.A.	Austin	Texas
United States	Peter A. Holt, MD	Baltimore	Maryland
United States	Neshaminy Medical, PC	Bensalem	Pennsylvania
United States	Lovelace Scientific Research, Inc.	Beverly Hills	California
United States	South Jersey Medical Associates, PA	Blackwood	New Jersey
United States	Intermountain Orthopaedics	Boise	Idaho
United States	Twin Cities Clinical Research	Brooklyn Center	Minnesota
United States	Professional Clinical Research, Inc	Cadillac	Michigan
United States	MED Investigations	Carmichael	California
United States	East Valley Family Physicians	Chandler	Arizona
United States	Rapid Medical Research, Inc	Cleveland	Ohio
United States	Radiant Research	Columbus	Ohio
United States	Radiant Research Dallas North	Dallas	Texas
United States	Seidman Clinical Trials	Delray Beach	Florida
United States	Westminster Family Medicine	Erie	Pennsylvania
United States	MED Investigations, Inc.	Fair Oaks	California
United States	Phase III Clinical Research	Fall River	Massachusetts
United States	Feasterville Family Health Care Center	Feasterville	Pennsylvania
United States	Universal BioPharma Research, Inc.	Fresno	California
United States	Florida Medical Research Institute	Gainesville	Florida
United States	Internal Medical Associates	Grand Island	Nebraska
United States	Southeastern Pennsylvania Medical Institute	Havertown	Pennsylvania
United States	South Florida Clinical Research Center	Hollywood	Florida
United States	Health Awareness, Inc.	Jupiter	Florida
United States	The Center for Pharmaceutical Research	Kansas City	Missouri
United States	Holston Medical Group	Kingsport	Tennessee
United States	Suncoast Internal Medicine Consultants	Largo	Florida
United States	AppleMed Research, Inc.	Miami	Florida
United States	Advanced Healthcare	Milwaukee	Wisconsin
United States	Coastal Clinical Research Inc	Mobile	Alabama
United States	Radiant Research, Inc. - Akron	Mogadore	Ohio
United States	Medical Specialists Clinical Research Center	Munster	Indiana
United States	Best Clinical Trial, LLC	New Orleans	Louisiana
United States	Suncoast Clinical Research, Inc.	New Port Richey	Florida
United States	Health Research of Hampton Roads, Inc.	Newport News	Virginia
United States	Heartland Research Associates, LLC	Newton	Kansas
United States	Sunshine Research Center, LLC	Opa Locka	Florida
United States	Peninsula Research, Inc.	Ormond Beach	Florida
United States	Andres Patron DO PA	Pembroke Pines	Florida
United States	University Clinical Research, Inc.	Pembroke Pines	Florida
United States	Clinical Research Source, Inc	Perrysburg	Ohio
United States	Radiant Research	Philadelphia	Pennsylvania
United States	HOPE Research Institute	Phoenix	Arizona
United States	Radiant Research - St Petersburg	Pinellas Park	Florida
United States	Sunrise Medical Research	Plantation	Florida
United States	Coastal Medical Research	Port Orange	Florida
United States	North Carolina Arthritis & Allergy Care Center	Raleigh	North Carolina
United States	Quality Research, Inc.	San Antonio	Texas
United States	Radiant Research - San Antonio	San Antonio	Texas
United States	Santa Barbara Clinical Research, Inc	Santa Barbara	California
United States	Pacific Arthritis Center Medical Group	Santa Maria	California
United States	The Physicians Clinic of Spokane	Spokane	Washington
United States	St. Louis Center for Clinical Research	St. Louis	Missouri
United States	Clinical Research Consultants, LLC	Stratford	Connecticut
United States	Radiant Research	Stuart	Florida
United States	Texas Research Center, LLP	Sugar Land	Texas
United States	River Region Research, LLC	Tallassee	Alabama
United States	Tidewater Integrated Medical Research	Virginia Beach	Virginia
United States	Omega Medical Research	Warwick	Rhode Island
United States	The Center for Rheumatology and Bone Research	Wheaton	Maryland
United States	Heartland Research Associates, LLC	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain in the target knee (WOMAC pain index);
Primary	functional capacity in the target knee (WOMAC function index); and
Primary	global rating of benefit (100 mm Visual Analogue Scale, VAS).
Secondary	Efficacy of Diclofenac Sodium Gel 1% with regard attainment of:
Secondary	Low pain intensity in either knee; and
Secondary	Low functional impairment in either knee.
Secondary	Safety of Diclofenac Sodium Gel 1% assessed by:
Secondary	monitoring adverse events; and
Secondary	laboratory evaluations.