Efficacy and Safety of Topical Diclofenac Combined With Oral Diclofenac in the Treatment of Knee Osteoarthritis
1 other identifier
interventional
750
1 country
22
Brief Summary
Oral non-steroidal anti-inflammatory drugs (NSAIDs) are a recommended treatment for the symptoms of osteoarthritis of the knee. However, NSAIDs may cause a range of negative side effects, including stomach pain, heartburn, bleeding stomach ulcer, and liver or kidney abnormality. A topical NSAID may relieve pain and other symptoms of osteoarthritis of the knee, while minimizing the side effects common to oral NSAIDs. The purpose of this study is to determine the safety and effectiveness of a topical NSAID when used alone or when combined with an oral NSAID in the treatment of osteoarthritis of the knee.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2004
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2004
CompletedFirst Submitted
Initial submission to the registry
April 21, 2005
CompletedFirst Posted
Study publicly available on registry
April 22, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2005
CompletedJanuary 5, 2007
January 1, 2007
April 21, 2005
January 4, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
pain
physical function
patient overall health assessment
Secondary Outcomes (2)
stiffness
patient global assessment
Interventions
Eligibility Criteria
You may qualify if:
- Primary osteoarthritis of the knee, verified radiographically
- Moderate flare of pain in the knee after washout of stable therapy
- If female, non-pregnant
- Ability to swallow moderately-sized tablets
You may not qualify if:
- Secondary osteoarthritis of the knee
- Major knee surgery at any time, or minor knee surgery in previous year
- Severe uncontrolled heart, liver or kidney disease
- Ulcer or bleeding from the stomach
- Corticosteroid use
- Fibromyalgia
- Skin disorder of the knee
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Coastal Clinical Research
Mobile, Alabama, 36608, United States
Redpoint Research
Phoenix, Arizona, 85029, United States
OMC Clinical
Beverly Hills, California, 90211, United States
Associated Pharmaceutical Research
Buena Park, California, 90620, United States
Med Investigators
Fair Oaks, California, 95628, United States
Desert Medical Advances
Palm Desert, California, 92260, United States
Boling Clinical Trials
Upland, California, 91786, United States
Tampa Bay Medical Research Inc.
Clearwater, Florida, 33761, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
Medisphere Medical Research
Evansville, Indiana, 47714, United States
Synergy Medical Education Alliance
Saginaw, Michigan, 48602, United States
Redrock Research Center
Las Vegas, Nevada, 89146, United States
Partners in Primary Care
Voorhees Township, New Jersey, 08043, United States
Camp Hill Clinical Research Center
Camp Hill, Pennsylvania, 17011, United States
Primary Physicians Research
Pittsburgh, Pennsylvania, 15241, United States
University Orthopedics Center
State College, Pennsylvania, 16801, United States
Omega Medical Research
Warwick, Rhode Island, 02886, United States
Clinical Research Associates
Nashville, Tennessee, 37203, United States
Research Across America
Dallas, Texas, 75234, United States
Sam Clinical Research Center
San Antonio, Texas, 78229, United States
Hamptom Roads Center for Clinical Research
Norfolk, Virginia, 23502-9921, United States
National Clinical Research
Richmond, Virginia, 23294, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention 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
April 21, 2005
First Posted
April 22, 2005
Study Start
February 1, 2004
Study Completion
September 1, 2005
Last Updated
January 5, 2007
Record last verified: 2007-01