An Effectiveness and Safety Study of IDEA-033 in Comparison to Oral Naproxen and Placebo for the Treatment of Osteoarthritis of the Knee
NCT ID: NCT00211549
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
875 participants
INTERVENTIONAL
2005-06-30
Brief Summary
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Detailed Description
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Patients will receive one of five treatments for 12 weeks:Three doses of IDEA-033, or naproxen 1 g over-encapsulated tablet + placebo or placebo
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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IDEA-033
Eligibility Criteria
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Inclusion Criteria
* Moderate pain in the most involved knee when not taking NSAIDs
* Must have used an oral NSAID on at least three days per week for last three months or 25 of 30 days before screening
* Demonstrate x-ray evidence of osteoarthritis in the most involved knee during the last six months
Exclusion Criteria
* Intra-articular injections or arthroscopy of the most involved knee during three months before Screening visit
* Inflammation of the most involved knee that could be related to gout or pseudogout-induced synovitis or infection
* A large bulging effusion
* History of gout or pseudo-gout induced synovitis or infection of the more severe knee
* History of partial or total knee replacement in either 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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Birmingham, Alabama, United States
Montgomery, Alabama, United States
Drug Research and Analysis Corporation
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
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
Temecula, California, United States
Vista, California, United States
Northglenn, Colorado, United States
Danbury, Connecticut, United States
Clearwater, Florida, United States
Coral Gables, Florida, United States
Daytona Beach, Florida, United States
DeLand, Florida, United States
Fort Lauderdale, Florida, United States
Fort Myers, Florida, United States
Gainesville, Florida, United States
Hialeah, Florida, United States
Jacksonville, 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
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Evansville, Indiana, United States
Arkansas City, Kansas, United States
Kansas City, Kansas, United States
Newton, Kansas, United States
Wichita, Kansas, United States
Louisville, Kentucky, United States
Towson, Maryland, 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
Kansas City, Missouri, 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
Cumberland Research Associates L L C
Fayetteville, North Carolina, United States
Wilmington, 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
Colombus, Ohio, United States
Columbus, Ohio, United States
Franklin, Ohio, United States
Perrysburg, Ohio, United States
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-04
Identifier Type: -
Identifier Source: org_study_id
NCT00371917
Identifier Type: -
Identifier Source: nct_alias
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