Efficacy and Safety of Diclofenac Sodium Gel in Hand Osteoarthritis
1 other identifier
interventional
360
1 country
69
Brief Summary
This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of hand 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 May 2005
Shorter than P25 for phase_3
69 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
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedApril 14, 2015
April 1, 2015
September 13, 2005
April 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
OA pain intensity in target hand at Week 4 and 6
Total AUSCAN score in target hand at Week 4 and 6
Global rating of disease activity by patient at Week 4 and 6
Secondary Outcomes (5)
OA pain intensity and total AUSCAN score in target hand, and global rating of disease activity by patient at Weeks 1, 2 and 8
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 in target hand and use of rescue medication recorded in diary
Global evaluation of treatment at final visit
Treatment responder rate according to OARSI criteria
Interventions
Eligibility Criteria
You may qualify if:
- Osteoarthritis of the hand
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 (69)
Alabama Clinical Therapeutics
Birmingham, Alabama, 35235, United States
MedSearch, LLC
Calera, Alabama, 35040, United States
Montgomery Rheumatology Associates
Montgomery, Alabama, 36111, United States
Drug Research & Analysis Corp
Montgomery, Alabama, 36124, United States
Arizona Center for Clinical Research
Glendale, Arizona, 85306, United States
Quality of Life Medical Research Center, LLC
Tucson, Arizona, 85712, United States
Lovelace Scientific Resources, Inc.
Beverly Hills, California, 90211, United States
Med Investigations/Med Center
Carmichael, California, 95608, United States
H. Richard Barthel,MD, Inc.
Santa Barbara, California, 93105, United States
Clinical Research of CT/NY
Danbury, Connecticut, 06810, United States
Allergy and Arthritis Associates
Hamden, Connecticut, 06518, United States
Arthritis & Osteoporosis Center, PC
Hamden, Connecticut, 06518, United States
Clinical Research Consultants
Stratford, Connecticut, 06615, United States
Health Core
Newark, Delaware, 19713, United States
Clinical Research of West Florida
Clearwater, Florida, 33765, United States
The Community Research of South Florida
Hialeah, Florida, 33013, United States
Health Awareness, Inc.
Jupiter, Florida, 33458, United States
Miami Research Associates
Miami, Florida, 33173, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652, United States
Arthritis Research of Florida, Inc.
Palm Harbor, Florida, 34684, United States
University Clinical Research, Inc.
Pembroke Pines, Florida, 33024, United States
Andres Patron, DO PA
Pembroke Pines, Florida, 33028, United States
Coastal Medical Research
Port Orange, Florida, 32127, United States
University Neurology
Sarasota, Florida, 34243, United States
Southwest Florida Clinical Research Center
Tampa, Florida, 33609, United States
Radiant Research - Atlanta West
Atlanta, Georgia, 30308, United States
Intermountain Orthopaedics
Boise, Idaho, 83702, United States
Allan B. Aven, MD, SC
Arlington Heights, Illinois, 60005, United States
Heartland Research Associates, LLC
Arkansas City, Kansas, 67005, United States
Chesapeake Medical Research, LLC
Baltimore, Maryland, 21239, United States
Arthritis Associates, Inc.
Peabody, Massachusetts, 01960, United States
Clinsite
Ann Arbor, Michigan, 48106, United States
Twin Cities Clinical Research
Brooklyn Center, Minnesota, 55430, United States
Radiant Research - Minneapolis
Edina, Minnesota, 55435, United States
PrimeCare Research Associates
Florissant, Missouri, 63031, United States
Meridian Clinical Research, LLC
Omaha, Nebraska, 68134, United States
Comprehensive Clinical Research
Turnersville, New Jersey, 08012, United States
Unifour Medical Research Associates
Hickory, North Carolina, 28601, United States
Crescent Medical Research
Salisbury, North Carolina, 28144, United States
Carolina Clinical Research
Winston-Salem, North Carolina, 27103, United States
Wells Institute for Heatlh Awareness
Kettering, Ohio, 45429, United States
Clinical Research Source
Perrysburg, Ohio, 43551, United States
PRO Research
Eugene, Oregon, 97401, United States
Allegheny Pain Management
Altoona, Pennsylvania, 16602, United States
Neshaminy Medical, PC
Bensalem, Pennsylvania, 19020, United States
Medical Group @ Marple Commons
Broomall, Pennsylvania, 19008, 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
Radiant Research - Reading
Wyomissing, Pennsylvania, 19610, United States
Partners in Clinical Research
Woonsocket, Rhode Island, 02895, United States
Radiant Research - Anderson
Anderson, South Carolina, 29621, United States
Palmetto Medical Research
Mt. Pleasant, South Carolina, 29464, United States
Harmony Research, Inc.
Johnson City, Tennessee, 37601, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
Amarillo Center for Clinical Research
Amarillo, Texas, 79124, United States
Walter F. Chase, MD, PA
Austin, Texas, 78705, United States
Quality Research, Inc.
San Antonio, Texas, 78209, United States
Radiant Research - San Antonio Northeast
San Antonio, Texas, 78217, United States
Radiant Research - San Antonio
San Antonio, Texas, 78229, United States
Texas Research Center, LLP
Sugar Land, Texas, 77479, United States
Intermoutain Clinical Research
Salt Lake City, Utah, 84102, United States
Radiant Research - Salt Lake City
Salt Lake City, Utah, 84107, United States
Charlottesville Medical Research
Charlottesville, Virginia, 22911, United States
Health Research of Hampton Roads, Inc.
Newport News, Virginia, 23606, United States
Radiant Research - Tacoma
Lakewood, Washington, 98499, United States
Advanced Healthcare, SC
Milwaukee, Wisconsin, 53209, United States
Dean Medical Center - Oregon Clinic
Oregon, Wisconsin, 53575, United States
Related Publications (2)
Barthel HR, Peniston JH, Clark MB, Gold MS, Altman RD. Correlation of pain relief with physical function in hand osteoarthritis: randomized controlled trial post hoc analysis. Arthritis Res Ther. 2010;12(1):R7. doi: 10.1186/ar2906. Epub 2010 Jan 11.
PMID: 20064249DERIVEDAltman RD, Dreiser RL, Fisher CL, Chase WF, Dreher DS, Zacher J. Diclofenac sodium gel in patients with primary hand osteoarthritis: a randomized, double-blind, placebo-controlled trial. J Rheumatol. 2009 Sep;36(9):1991-9. doi: 10.3899/jrheum.081316. Epub 2009 Jul 31.
PMID: 19648310DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 15, 2005
Study Start
May 1, 2005
Study Completion
December 1, 2005
Last Updated
April 14, 2015
Record last verified: 2015-04