Efficacy and Safety of Diclofenac Sodium Gel (DSG) in Knee Osteoarthritis
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.
1 other identifier
interventional
420
1 country
64
Brief Summary
This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of knee osteoarthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2006
Shorter than P25 for phase_3
64 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 24, 2007
CompletedFirst Posted
Study publicly available on registry
January 25, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedDecember 18, 2007
December 1, 2007
January 24, 2007
December 13, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Osteoarthritis of the knee
You may not qualify if:
- Other rheumatic disease, such as rheumatoid arthritis
- Active gastrointestinal ulcer during the last year
- Known allergy to analgesic drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (64)
Coastal Clinical Research Inc
Mobile, Alabama, 33608, United States
River Region Research, LLC
Tallassee, Alabama, 36078, United States
East Valley Family Physicians
Chandler, Arizona, 85224, United States
HOPE Research Institute
Phoenix, Arizona, 85050, United States
Heartland Research Associates LLC
Arkansas City, Arkansas, 67005, United States
Lovelace Scientific Research, Inc.
Beverly Hills, California, 92011, United States
MED Investigations
Carmichael, California, 95608, United States
MED Investigations, Inc.
Fair Oaks, California, 95628, United States
Universal BioPharma Research, Inc.
Fresno, California, 93703, United States
Santa Barbara Clinical Research, Inc
Santa Barbara, California, 93108, United States
Pacific Arthritis Center Medical Group
Santa Maria, California, 93454, United States
Clinical Research Consultants, LLC
Stratford, Connecticut, 06615, United States
Seidman Clinical Trials
Delray Beach, Florida, 33484, United States
Florida Medical Research Institute
Gainesville, Florida, 32607, United States
South Florida Clinical Research Center
Hollywood, Florida, 33023, United States
Health Awareness, Inc.
Jupiter, Florida, 33458, United States
Suncoast Internal Medicine Consultants
Largo, Florida, 33774, United States
AppleMed Research, Inc.
Miami, Florida, 33155, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652, United States
Sunshine Research Center, LLC
Opa-locka, Florida, 33056, United States
Peninsula Research, Inc.
Ormond Beach, Florida, 32174, United States
University Clinical Research, Inc.
Pembroke Pines, Florida, 33024, United States
Andres Patron DO PA
Pembroke Pines, Florida, 33028, United States
Radiant Research - St Petersburg
Pinellas Park, Florida, 33781, United States
Sunrise Medical Research
Plantation, Florida, 33324, United States
Coastal Medical Research
Port Orange, Florida, 32127, United States
Radiant Research
Stuart, Florida, 34996, United States
Intermountain Orthopaedics
Boise, Idaho, 83702, United States
Medical Specialists Clinical Research Center
Munster, Indiana, 46321, United States
Heartland Research Associates, LLC
Newton, Kansas, 67114, United States
Heartland Research Associates, LLC
Wichita, Kansas, 67205, United States
Best Clinical Trial, LLC
New Orleans, Louisiana, 70115, United States
Peter A. Holt, MD
Baltimore, Maryland, 21239, United States
The Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902, United States
Phase III Clinical Research
Fall River, Massachusetts, 02720, United States
Professional Clinical Research, Inc
Cadillac, Michigan, 49601, United States
Twin Cities Clinical Research
Brooklyn Center, Minnesota, 55430, United States
The Center for Pharmaceutical Research
Kansas City, Missouri, 64114, United States
St. Louis Center for Clinical Research
St Louis, Missouri, 63128, United States
Internal Medical Associates
Grand Island, Nebraska, 68803, United States
South Jersey Medical Associates, PA
Blackwood, New Jersey, 08012, United States
North Carolina Arthritis & Allergy Care Center
Raleigh, North Carolina, 27609, United States
Rapid Medical Research, Inc
Cleveland, Ohio, 44122, United States
Radiant Research
Columbus, Ohio, 43212, United States
Radiant Research, Inc. - Akron
Mogadore, Ohio, 44260, United States
Clinical Research Source, Inc
Perrysburg, Ohio, 43551, United States
Neshaminy Medical, PC
Bensalem, Pennsylvania, 19020, United States
Westminster Family Medicine
Erie, Pennsylvania, 16506, United States
Feasterville Family Health Care Center
Feasterville, Pennsylvania, 19053, United States
Southeastern Pennsylvania Medical Institute
Havertown, Pennsylvania, 19083, United States
Radiant Research
Philadelphia, Pennsylvania, 19115, United States
Omega Medical Research
Warwick, Rhode Island, 02886, United States
Radiant Research - Anderson
Anderson, South Carolina, 29621, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
Amarillo Center for Clinical Research
Amarillo, Texas, 79124, United States
Walter F. Chase, M.D., P.A.
Austin, Texas, 78705, United States
Radiant Research Dallas North
Dallas, Texas, 75231, United States
Quality Research, Inc.
San Antonio, Texas, 78209, United States
Radiant Research - San Antonio
San Antonio, Texas, 78229, United States
Texas Research Center, LLP
Sugar Land, Texas, 77479, United States
Health Research of Hampton Roads, Inc.
Newport News, Virginia, 23606, United States
Tidewater Integrated Medical Research
Virginia Beach, Virginia, 23451, United States
The Physicians Clinic of Spokane
Spokane, Washington, 99204, United States
Advanced Healthcare
Milwaukee, Wisconsin, 53209, United States
Related Publications (1)
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.
PMID: 21174485DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roy Altman, MD
University of California, in Los Angeles, Division of Rheumatology, 310 206 7866
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 24, 2007
First Posted
January 25, 2007
Study Start
November 1, 2006
Study Completion
June 1, 2007
Last Updated
December 18, 2007
Record last verified: 2007-12