A Long-Term Safety Study of IDEA-033 in Comparison to Oral Naproxen for the Treatment of Osteoarthritis of the Knee
NCT ID: NCT00265304
Last Updated: 2009-03-20
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
PHASE2
550 participants
INTERVENTIONAL
2005-07-31
Brief Summary
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Detailed Description
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Patients assigned to IDEA-033 in Study 17-007 will topically apply 100 mg per knee of ketoprofen gel twice daily and take one oral placebo capsule twice daily for 52 weeks. Patients assigned to oral naproxen or placebo in Study 17-007 will take one 500 mg naproxen over-encapsulated tablet orally twice daily and apply placebo topical gel twice daily for 52 weeks. Patients who did not participate in Study 17-007 will be randomized to receive one of these two treatments.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Ketoprofen
Eligibility Criteria
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Inclusion Criteria
* Patients who did not complete or discontinue from Study 17-007 must have osteoarthritis of both knees for a minimum of six months
* Have moderate pain in the most involved knee when not taking non-steroidal anti-inflammatory drugs (NSAIDs)
* Must have used an oral NSAID on at least three days per week for the last three months, or 25 of the 30 days before screening
* Demonstrate x-ray evidence of osteoarthritis in the most involved knee during the last six months
Exclusion Criteria
* For patients who did not participate in Study 17-007: having Grade 1 or Grade 4 severity of the most involved knee based on x-ray criteria
* Received intra-articular injections or arthroscopy of the most involved knee during three months before screening visit
* Have a large bulging effusion, or have inflammation of the most involved knee that could be related to gout, pseudogout-induced synovitis, or infection
* Have a history of partial or total knee replacement in either knee, or have a history of gout, pseudo-gout induced synovitis, or infection of the more severe knee
18 Years
ALL
No
Sponsors
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IDEA AG
INDUSTRY
Principal Investigators
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IDEA AG Clinical Trial
Role: STUDY_DIRECTOR
IDEA AG
Locations
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Garden Grove, California, United States
Irvine, California, United States
Paramount, California, United States
Rancho Mirage, California, United States
San Diego, California, United States
Spring Valley, California, United States
Vista, California, United States
Capstone Clinical Trials Inc
Birmingham, Alabama, United States
Montgomery, Alabama, United States
Montgomery, Alabama, United States
Northport, Alabama, United States
Mesa, Arizona, United States
Phoenix, Arizona, United States
Tempe, Arizona, United States
Anaheim, California, United States
Encinitas, California, United States
Fair Oaks, California, United States
Northglenn, Colorado, United States
Danbury, Connecticut, United States
Clearwater, Florida, United States
Coral Gables, Florida, United States
Radiant Research-daytona
Daytona Beach, Florida, United States
DeLand, Florida, United States
Fort Myers, Florida, United States
Gainesville, Florida, United States
The Community Research of South Florida
Hialeah, Florida, United States
Ocala, Florida, United States
Ocala, Florida, United States
Ocoee, Florida, United States
Palm Harbor, Florida, United States
Pembroke Pines, Florida, United States
Port Orange, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
International Research Center
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Evansville, Indiana, United States
Arkansas City, Kansas, United States
Newton, Kansas, United States
Wichita, Kansas, United States
Louisville, Kentucky, United States
Milford, Massachusetts, United States
East Lansing, Michigan, United States
Kalamazoo, Michigan, United States
Lansing, Michigan, United States
Flowood, Mississippi, United States
Jackson, Mississippi, United States
Bozeman, Montana, United States
Las Vegas, Nevada, United States
Berlin, New Jersey, United States
Dover, New Jersey, United States
Binghamton, New York, United States
Manilus, New York, United States
Rochester, New York, United States
Durham, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Community Research Managment Associates
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Columbus, Ohio, United States
Franklin, Ohio, United States
Perrysburg, Ohio, United States
Gilbert Medical Research
Bethany, Oklahoma, United States
Beaver, Pennsylvania, United States
Bensalem, Pennsylvania, United States
Duncansville, Pennsylvania, United States
Harleysville, Pennsylvania, United States
Levittown, Pennsylvania, United States
Penndel, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Warwick, Rhode Island, United States
Anderson, South Carolina, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Greer, South Carolina, United States
Memphis, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Lake Jackson, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
Spokane, Washington, United States
Spokane, Washington, United States
Glendale, Wisconsin, United States
Countries
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Other Identifiers
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CL-033-III-05
Identifier Type: -
Identifier Source: org_study_id
NCT00371358
Identifier Type: -
Identifier Source: nct_alias
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