Efficacy and Safety of Diclofenac Sodium Gel (DSG) in Knee Osteoarthritis
- Conditions
- Osteoarthritis of the Knee
- Interventions
- Drug: Placebo
- Registration Number
- NCT00426621
- Lead Sponsor
- Novartis
- Brief Summary
This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of knee osteoarthritis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 420
- Osteoarthritis of the knee
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Diclofenac Sodium Gel - 2 Placebo -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
Trial Locations
- Locations (61)
Holston Medical Group
🇺🇸Kingsport, Tennessee, United States
North Carolina Arthritis & Allergy Care Center
🇺🇸Raleigh, North Carolina, United States
Texas Research Center, LLP
🇺🇸Sugar Land, Texas, United States
Universal BioPharma Research, Inc.
🇺🇸Fresno, California, United States
MED Investigations
🇺🇸Carmichael, California, United States
Coastal Clinical Research Inc
🇺🇸Mobile, Alabama, United States
Radiant Research - Anderson
🇺🇸Anderson, South Carolina, United States
Heartland Research Associates, LLC
🇺🇸Wichita, Kansas, United States
AppleMed Research, Inc.
🇺🇸Miami, Florida, United States
Rapid Medical Research, Inc
🇺🇸Cleveland, Ohio, United States
HOPE Research Institute
🇺🇸Phoenix, Arizona, United States
Quality Research, Inc.
🇺🇸San Antonio, Texas, United States
Radiant Research - San Antonio
🇺🇸San Antonio, Texas, United States
Twin Cities Clinical Research
🇺🇸Brooklyn Center, Minnesota, United States
River Region Research, LLC
🇺🇸Tallassee, Alabama, United States
MED Investigations, Inc.
🇺🇸Fair Oaks, California, United States
Santa Barbara Clinical Research, Inc
🇺🇸Santa Barbara, California, United States
Pacific Arthritis Center Medical Group
🇺🇸Santa Maria, California, United States
Radiant Research
🇺🇸Philadelphia, Pennsylvania, United States
Medical Specialists Clinical Research Center
🇺🇸Munster, Indiana, United States
St. Louis Center for Clinical Research
🇺🇸St. Louis, Missouri, United States
The Center for Pharmaceutical Research
🇺🇸Kansas City, Missouri, United States
Clinical Research Source, Inc
🇺🇸Perrysburg, Ohio, United States
Omega Medical Research
🇺🇸Warwick, Rhode Island, United States
Radiant Research Dallas North
🇺🇸Dallas, Texas, United States
Amarillo Center for Clinical Research
🇺🇸Amarillo, Texas, United States
Walter F. Chase, M.D., P.A.
🇺🇸Austin, Texas, United States
Tidewater Integrated Medical Research
🇺🇸Virginia Beach, Virginia, United States
Health Research of Hampton Roads, Inc.
🇺🇸Newport News, Virginia, United States
The Physicians Clinic of Spokane
🇺🇸Spokane, Washington, United States
South Jersey Medical Associates, PA
🇺🇸Blackwood, New Jersey, United States
Andres Patron DO PA
🇺🇸Pembroke Pines, Florida, United States
East Valley Family Physicians
🇺🇸Chandler, Arizona, United States
South Florida Clinical Research Center
🇺🇸Hollywood, Florida, United States
Florida Medical Research Institute
🇺🇸Gainesville, Florida, United States
Health Awareness, Inc.
🇺🇸Jupiter, Florida, United States
Lovelace Scientific Research, Inc.
🇺🇸Beverly Hills, California, United States
Sunrise Medical Research
🇺🇸Plantation, Florida, United States
Peninsula Research, Inc.
🇺🇸Ormond Beach, Florida, United States
Radiant Research - St Petersburg
🇺🇸Pinellas Park, Florida, United States
Peter A. Holt, MD
🇺🇸Baltimore, Maryland, United States
Internal Medical Associates
🇺🇸Grand Island, Nebraska, United States
Radiant Research, Inc. - Akron
🇺🇸Mogadore, Ohio, United States
Neshaminy Medical, PC
🇺🇸Bensalem, Pennsylvania, United States
Westminster Family Medicine
🇺🇸Erie, Pennsylvania, United States
Feasterville Family Health Care Center
🇺🇸Feasterville, Pennsylvania, United States
Southeastern Pennsylvania Medical Institute
🇺🇸Havertown, Pennsylvania, United States
Advanced Healthcare
🇺🇸Milwaukee, Wisconsin, United States
Suncoast Internal Medicine Consultants
🇺🇸Largo, Florida, United States
Clinical Research Consultants, LLC
🇺🇸Stratford, Connecticut, United States
Professional Clinical Research, Inc
🇺🇸Cadillac, Michigan, United States
Heartland Research Associates LLC
🇺🇸Arkansas City, Arkansas, United States
Seidman Clinical Trials
🇺🇸Delray Beach, Florida, United States
Phase III Clinical Research
🇺🇸Fall River, Massachusetts, United States
Sunshine Research Center, LLC
🇺🇸Opa Locka, Florida, United States
Coastal Medical Research
🇺🇸Port Orange, Florida, United States
Best Clinical Trial, LLC
🇺🇸New Orleans, Louisiana, United States
University Clinical Research, Inc.
🇺🇸Pembroke Pines, Florida, United States
Intermountain Orthopaedics
🇺🇸Boise, Idaho, United States
Suncoast Clinical Research, Inc.
🇺🇸New Port Richey, Florida, United States
The Center for Rheumatology and Bone Research
🇺🇸Wheaton, Maryland, United States