Clinical trial NCT00426621: Efficacy and Safety of Diclofenac Sodium Gel (DSG) in Knee Osteoarthritis
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis of the Knee
Keywords: Knee osteoarthritis, degenerative joint disease, knee pain, joint pain, topical NSAID,
diclofenac sodium
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-01-25
Enrollment: 420
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: pain in the target knee (WOMAC pain index);
measure: functional capacity in the target knee (WOMAC function index); and
measure: global rating of benefit (100 mm Visual Analogue Scale, VAS).
Secondary outcomes:
measure: Efficacy of Diclofenac Sodium Gel 1% with regard attainment of:
measure: Low pain intensity in either knee; and
measure: Low functional impairment in either knee.
measure: Safety of Diclofenac Sodium Gel 1% assessed by:
measure: monitoring adverse events; and
measure: laboratory evaluations.
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Coastal Clinical Research Inc
state: Alabama
city: Tallassee
country: United States
facility: River Region Research, LLC
state: Alabama
city: Chandler
country: United States
facility: East Valley Family Physicians
state: Arizona
city: Phoenix
country: United States
facility: HOPE Research Institute
state: Arizona
city: Arkansas City
country: United States
facility: Heartland Research Associates LLC
state: Arkansas
city: Beverly Hills
country: United States
facility: Lovelace Scientific Research, Inc.
state: California
city: Carmichael
country: United States
facility: MED Investigations
state: California
city: Fair Oaks
country: United States
facility: MED Investigations, Inc.
state: California
city: Fresno
country: United States
facility: Universal BioPharma Research, Inc.
state: California
city: Santa Barbara
country: United States
facility: Santa Barbara Clinical Research, Inc
state: California
city: Santa Maria
country: United States
facility: Pacific Arthritis Center Medical Group
state: California
city: Stratford
country: United States
facility: Clinical Research Consultants, LLC
state: Connecticut
city: Delray Beach
country: United States
facility: Seidman Clinical Trials
state: Florida
city: Gainesville
country: United States
facility: Florida Medical Research Institute
state: Florida
city: Hollywood
country: United States
facility: South Florida Clinical Research Center
state: Florida
city: Jupiter
country: United States
facility: Health Awareness, Inc.
state: Florida
city: Largo
country: United States
facility: Suncoast Internal Medicine Consultants
state: Florida
city: Miami
country: United States
facility: AppleMed Research, Inc.
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research, Inc.
state: Florida
city: Opa Locka
country: United States
facility: Sunshine Research Center, LLC
state: Florida
city: Ormond Beach
country: United States
facility: Peninsula Research, Inc.
state: Florida
city: Pembroke Pines
country: United States
facility: University Clinical Research, Inc.
state: Florida
city: Pembroke Pines
country: United States
facility: Andres Patron DO PA
state: Florida
city: Pinellas Park
country: United States
facility: Radiant Research - St Petersburg
state: Florida
city: Plantation
country: United States
facility: Sunrise Medical Research
state: Florida
city: Port Orange
country: United States
facility: Coastal Medical Research
state: Florida
city: Stuart
country: United States
facility: Radiant Research
state: Florida
city: Boise
country: United States
facility: Intermountain Orthopaedics
state: Idaho
city: Munster
country: United States
facility: Medical Specialists Clinical Research Center
state: Indiana
city: Newton
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: Wichita
country: United States
facility: Heartland Research Associates, LLC
state: Kansas
city: New Orleans
country: United States
facility: Best Clinical Trial, LLC
state: Louisiana
city: Baltimore
country: United States
facility: Peter A. Holt, MD
state: Maryland
city: Wheaton
country: United States
facility: The Center for Rheumatology and Bone Research
state: Maryland
city: Fall River
country: United States
facility: Phase III Clinical Research
state: Massachusetts
city: Cadillac
country: United States
facility: Professional Clinical Research, Inc
state: Michigan
city: Brooklyn Center
country: United States
facility: Twin Cities Clinical Research
state: Minnesota
city: Kansas City
country: United States
facility: The Center for Pharmaceutical Research
state: Missouri
city: St. Louis
country: United States
facility: St. Louis Center for Clinical Research
state: Missouri
city: Grand Island
country: United States
facility: Internal Medical Associates
state: Nebraska
city: Blackwood
country: United States
facility: South Jersey Medical Associates, PA
state: New Jersey
city: Raleigh
country: United States
facility: North Carolina Arthritis & Allergy Care Center
state: North Carolina
city: Cleveland
country: United States
facility: Rapid Medical Research, Inc
state: Ohio
city: Columbus
country: United States
facility: Radiant Research
state: Ohio
city: Mogadore
country: United States
facility: Radiant Research, Inc. - Akron
state: Ohio
city: Perrysburg
country: United States
facility: Clinical Research Source, Inc
state: Ohio
city: Bensalem
country: United States
facility: Neshaminy Medical, PC
state: Pennsylvania
city: Erie
country: United States
facility: Westminster Family Medicine
state: Pennsylvania
city: Feasterville
country: United States
facility: Feasterville Family Health Care Center
state: Pennsylvania
city: Havertown
country: United States
facility: Southeastern Pennsylvania Medical Institute
state: Pennsylvania
city: Philadelphia
country: United States
facility: Radiant Research
state: Pennsylvania
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Anderson
country: United States
facility: Radiant Research - Anderson
state: South Carolina
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Amarillo
country: United States
facility: Amarillo Center for Clinical Research
state: Texas
city: Austin
country: United States
facility: Walter F. Chase, M.D., P.A.
state: Texas
city: Dallas
country: United States
facility: Radiant Research Dallas North
state: Texas
city: San Antonio
country: United States
facility: Quality Research, Inc.
state: Texas
city: San Antonio
country: United States
facility: Radiant Research - San Antonio
state: Texas
city: Sugar Land
country: United States
facility: Texas Research Center, LLP
state: Texas
city: Newport News
country: United States
facility: Health Research of Hampton Roads, Inc.
state: Virginia
city: Virginia Beach
country: United States
facility: Tidewater Integrated Medical Research
state: Virginia
city: Spokane
country: United States
facility: The Physicians Clinic of Spokane
state: Washington
city: Milwaukee
country: United States
facility: Advanced Healthcare
state: Wisconsin
Study officials:
affiliation: University of California, in Los Angeles, Division of Rheumatology, 310 206 7866
name: Roy Altman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.