Study Evaluating the Efficacy and Safety of Topical Diclofenac Spray in Osteoarthritis of the Knee: Trial I
NCT ID: NCT00546507
Last Updated: 2010-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
650 participants
INTERVENTIONAL
2007-10-31
2008-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A
placebo
placebo
B
celecoxib 200 mg qd p.o.
celecoxib
C
TDS-943 40 mg bid topically
TDS-943 (topical diclofenac sodium 4% spray)
Interventions
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TDS-943 (topical diclofenac sodium 4% spray)
celecoxib
placebo
Eligibility Criteria
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Inclusion Criteria
* Osteoarthritis (OA) of at least one knee, verified by a weight-bearing radiograph
* Subject has taken an oral NSAID or analgesic at least 3 days during the past 30 days to treat knee OA pain
Exclusion Criteria
* Hypersensitivity (exacerbations of asthma, rhinitis, or urticaria) to sulfonamides, acetaminophen, diclofenac, celecoxib, aspirin, or any other NSAID
* History of myocardial infarction, congestive heart failure, stroke, coronary-artery bypass graft surgery, or any other significant cardiovascular disease, or is on any form of anticoagulation therapy other than low-dose aspirin (no more than 325 mg/day)
40 Years
ALL
No
Sponsors
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Mika Pharma GmbH
INDUSTRY
Responsible Party
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MIKA Pharma GmbH
Principal Investigators
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Medical Affairs
Role: STUDY_DIRECTOR
Mika Pharma GmbH
Locations
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Huntsville, Alabama, United States
Mobile, Alabama, United States
Mesa, Arizona, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Fair Oaks, California, United States
Pico Rivera, California, United States
Santa Barbara, California, United States
Torrance, California, United States
DeLand, Florida, United States
Jacksonville, Florida, United States
Kissimmee, Florida, United States
Ocala, Florida, United States
Ormond Beach, Florida, United States
Pembroke Pines, Florida, United States
Pinellas Park, Florida, United States
Stuart, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Gurnee, Illinois, United States
Morton, Illinois, United States
Peoria, Illinois, United States
Evansville, Indiana, United States
Baton Rouge, Louisiana, United States
Florissant, Missouri, United States
St Louis, Missouri, United States
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Perrysburg, Ohio, United States
Wallingford, Pennsylvania, United States
Cranston, Rhode Island, United States
Cordova, Tennessee, United States
Memphis, Tennessee, United States
Dallas, Texas, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Roanoke, Virginia, United States
Countries
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Other Identifiers
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TD-06-13
Identifier Type: -
Identifier Source: org_study_id