Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis
- Conditions
- Osteoarthritis
- Registration Number
- NCT00171665
- Lead Sponsor
- Novartis
- Brief Summary
This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of hand osteoarthritis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 360
Not provided
- Other rheumatic disease, such as rheumatoid arthritis
- Active gastrointestinal ulcer during the last year
- Known allergy to analgesic drugs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method OA pain intensity in target hand at Week 4 and 6 Global rating of disease activity by patient at Week 4 and 6 Total AUSCAN score in target hand at Week 4 and 6
- Secondary Outcome Measures
Name Time Method Global evaluation of treatment at final visit AUSCAN pain, stiffness and physical function scores in target hand, and global rating of benefit by patient at Weeks 1, 2, 4, 6 and 8 OA pain intensity and total AUSCAN score in target hand, and global rating of disease activity by patient at Weeks 1, 2 and 8 OA pain intensity in target hand and use of rescue medication recorded in diary Treatment responder rate according to OARSI criteria
Trial Locations
- Locations (69)
Montgomery Rheumatology Associates
🇺🇸Montgomery, Alabama, United States
Drug Research & Analysis Corp
🇺🇸Montgomery, Alabama, United States
Arizona Center for Clinical Research
🇺🇸Glendale, Arizona, United States
Quality of Life Medical Research Center, LLC
🇺🇸Tucson, Arizona, United States
Lovelace Scientific Resources, Inc.
🇺🇸Beverly Hills, California, United States
Allergy and Arthritis Associates
🇺🇸Hamden, Connecticut, United States
Arthritis & Osteoporosis Center, PC
🇺🇸Hamden, Connecticut, United States
Clinical Research Consultants
🇺🇸Stratford, Connecticut, United States
Health Core
🇺🇸Newark, Delaware, United States
Health Awareness, Inc.
🇺🇸Jupiter, Florida, United States
Suncoast Clinical Research, Inc.
🇺🇸New Port Richey, Florida, United States
Arthritis Research of Florida, Inc.
🇺🇸Palm Harbor, Florida, United States
Coastal Medical Research
🇺🇸Port Orange, Florida, United States
Southwest Florida Clinical Research Center
🇺🇸Tampa, Florida, United States
Heartland Research Associates, LLC
🇺🇸Arkansas City, Kansas, United States
Arthritis Associates, Inc.
🇺🇸Peabody, Massachusetts, United States
Twin Cities Clinical Research
🇺🇸Brooklyn Center, Minnesota, United States
Clinsite
🇺🇸Ann Arbor, Michigan, United States
Radiant Research - Minneapolis
🇺🇸Edina, Minnesota, United States
PrimeCare Research Associates
🇺🇸Florissant, Missouri, United States
Comprehensive Clinical Research
🇺🇸Turnersville, New Jersey, United States
Unifour Medical Research Associates
🇺🇸Hickory, North Carolina, United States
Crescent Medical Research
🇺🇸Salisbury, North Carolina, United States
Carolina Clinical Research
🇺🇸Winston Salem, North Carolina, United States
PRO Research
🇺🇸Eugene, Oregon, United States
Allegheny Pain Management
🇺🇸Altoona, Pennsylvania, United States
Clinical Research Source
🇺🇸Perrysburg, Ohio, United States
Westminster Family Medicine
🇺🇸Erie, Pennsylvania, United States
Medical Group @ Marple Commons
🇺🇸Broomall, Pennsylvania, United States
Neshaminy Medical, PC
🇺🇸Bensalem, Pennsylvania, United States
Southeastern Pennsylvania Medical Institute
🇺🇸Havertown, Pennsylvania, United States
Feasterville Family Health Care Center
🇺🇸Feasterville, Pennsylvania, United States
Radiant Research - Reading
🇺🇸Wyomissing, Pennsylvania, United States
Partners in Clinical Research
🇺🇸Woonsocket, Rhode Island, United States
Palmetto Medical Research
🇺🇸Mt. Pleasant, South Carolina, United States
Harmony Research, Inc.
🇺🇸Johnson City, Tennessee, United States
Walter F. Chase, MD, PA
🇺🇸Austin, Texas, United States
Amarillo Center for Clinical Research
🇺🇸Amarillo, Texas, United States
Charlottesville Medical Research
🇺🇸Charlottesville, Virginia, United States
Health Research of Hampton Roads, Inc.
🇺🇸Newport News, Virginia, United States
Radiant Research - Tacoma
🇺🇸Lakewood, Washington, United States
Dean Medical Center - Oregon Clinic
🇺🇸Oregon, Wisconsin, United States
Med Investigations/Med Center
🇺🇸Carmichael, California, United States
H. Richard Barthel,MD, Inc.
🇺🇸Santa Barbara, California, United States
Clinical Research of West Florida
🇺🇸Clearwater, Florida, United States
Andres Patron, DO PA
🇺🇸Pembroke Pines, Florida, United States
University Neurology
🇺🇸Sarasota, Florida, United States
Clinical Research of CT/NY
🇺🇸Danbury, Connecticut, United States
Radiant Research - Atlanta West
🇺🇸Atlanta, Georgia, United States
Intermountain Orthopaedics
🇺🇸Boise, Idaho, United States
Allan B. Aven, MD, SC
🇺🇸Arlington Heights, Illinois, United States
The Community Research of South Florida
🇺🇸Hialeah, Florida, United States
University Clinical Research, Inc.
🇺🇸Pembroke Pines, Florida, United States
Chesapeake Medical Research, LLC
🇺🇸Baltimore, Maryland, United States
Wells Institute for Heatlh Awareness
🇺🇸Kettering, Ohio, United States
Miami Research Associates
🇺🇸Miami, Florida, United States
Radiant Research - Anderson
🇺🇸Anderson, South Carolina, United States
Holston Medical Group
🇺🇸Kingsport, Tennessee, United States
Texas Research Center, LLP
🇺🇸Sugar Land, Texas, United States
Alabama Clinical Therapeutics
🇺🇸Birmingham, Alabama, United States
Quality Research, Inc.
🇺🇸San Antonio, Texas, United States
Radiant Research - San Antonio Northeast
🇺🇸San Antonio, Texas, United States
Radiant Research - San Antonio
🇺🇸San Antonio, Texas, United States
Intermoutain Clinical Research
🇺🇸Salt Lake City, Utah, United States
Radiant Research - Salt Lake City
🇺🇸Salt Lake City, Utah, United States
Advanced Healthcare, SC
🇺🇸Milwaukee, Wisconsin, United States
Meridian Clinical Research, LLC
🇺🇸Omaha, Nebraska, United States
MedSearch, LLC
🇺🇸Calera, Alabama, United States
Radiant Research
🇺🇸Philadelphia, Pennsylvania, United States