Study Evaluating the Efficacy and Safety of Topical Diclofenac Spray in Osteoarthritis of the Knee: Trial II
NCT ID: NCT00546832
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
2008-11-30
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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1
placebo
placebo
2
celecoxib 200 mg qd p.o.
celecoxib
3
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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Birmingham, Alabama, United States
Birmingham, Alabama, United States
Chandler, Arizona, United States
Phoenix, Arizona, United States
Little Rock, Arkansas, United States
Anaheim, California, United States
Anaheim, California, United States
Foothill Ranch, California, United States
Irvine, California, United States
Westlake Village, California, United States
Denver, Colorado, United States
Danbury, Connecticut, United States
Milford, Connecticut, United States
Stanford, Connecticut, United States
Boynton Beach, Florida, United States
Delray Beach, Florida, United States
New Smyrna Beach, Florida, United States
Ococee, Florida, United States
Sarasota, Florida, United States
St. Petersburg, Florida, United States
Blue Ridge, Georgia, United States
Marietta, Georgia, United States
Savannah, Georgia, United States
Boise, Idaho, United States
Chicago, Illinois, United States
Overland Park, Kansas, United States
Towson, Maryland, United States
Brockton, Massachusetts, United States
Kalamazoo, Michigan, United States
Kansas City, Missouri, United States
Omaha, Nebraska, United States
Berlin, New Jersey, United States
Medford, New Jersey, United States
Brooklyn, New York, United States
Asheville, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Marion, Ohio, United States
Oklahoma City, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Bensalem, Pennsylvania, United States
Duncansville, Pennsylvania, United States
Charleston, South Carolina, United States
Austin, Texas, United States
Nederland, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Virginia Beach, Virginia, United States
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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TD-07-14
Identifier Type: -
Identifier Source: org_study_id