A Long-Term Safety Study of IDEA-033 in Comparison to Oral Naproxen for the Treatment of Osteoarthritis of the Knee
A Double-Blind, Long-Term Evaluation of the Safety of IDEA-033 in Comparison to Oral Naproxen for the Treatment of the Signs and Symptoms of Osteoarthritis of the Knee
1 other identifier
interventional
550
1 country
93
Brief Summary
The purpose of this study is to evaluate the long-term safety of IDEA-033 (an anti-inflammatory pain-relieving drug applied to the skin) in comparison to naproxen (an anti-inflammatory pain-relieving drug taken by mouth) for the treatment of osteoarthritis of both knees.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
93 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
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 13, 2005
CompletedFirst Posted
Study publicly available on registry
December 14, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedMarch 20, 2009
March 1, 2009
2 years
December 13, 2005
March 19, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse events; Dermal-irritation scores; Changes in routine clinical laboratory tests and vital signs obtained at each visit.
Secondary Outcomes (1)
Change from baseline (Week 12 for patients who completed 17-007, baseline for those who did not) and mean value per visit for WOMAC pain, stiffness, and physical function scores; Subject Global Assessment of Response to Therapy.
Interventions
Eligibility Criteria
You may qualify if:
- Patients who completed Study 17-007 or discontinued from Study 17-007 due to lack of efficacy
- 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
You may not qualify if:
- Any patient currently receiving physical therapy to either knee or having a history of allergy, hypersensitivity or contraindication to ketoprofen, naproxen, or acetaminophen, an NSAID idiosyncrasy, or any other medical condition that would compromise the ability of the subject to complete the required assessments and visits
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- IDEA AGlead
Study Sites (93)
Capstone Clinical Trials Inc
Birmingham, Alabama, 35209, United States
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Montgomery, Alabama, 36101, United States
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Montgomery, Alabama, 36124, United States
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Northport, Alabama, 35476, United States
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Mesa, Arizona, 85206, United States
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Phoenix, Arizona, 85032, United States
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Tempe, Arizona, 85258, United States
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Anaheim, California, 92801, United States
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Encinitas, California, 92024, United States
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Fair Oaks, California, 95628, United States
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Garden Grove, California, 92840, United States
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Irvine, California, 92618, United States
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Paramount, California, 90723, United States
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Rancho Mirage, California, 92270, United States
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San Diego, California, 92120, United States
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Spring Valley, California, 91978, United States
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Vista, California, 92083, United States
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Northglenn, Colorado, 80234, United States
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Danbury, Connecticut, 06810, United States
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Clearwater, Florida, 33761, United States
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Coral Gables, Florida, 33134, United States
Radiant Research-daytona
Daytona Beach, Florida, 32114, United States
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DeLand, Florida, 32720, United States
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Fort Myers, Florida, 33916, United States
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Gainesville, Florida, 32607, United States
The Community Research of South Florida
Hialeah, Florida, 33013, United States
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Ocala, Florida, 34471, United States
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Ocala, Florida, 34474, United States
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Ocoee, Florida, 34761, United States
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Palm Harbor, Florida, 34684, United States
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Pembroke Pines, Florida, 33024, United States
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Port Orange, Florida, 32127, United States
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Tampa, Florida, 33614, United States
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West Palm Beach, Florida, 33409, United States
International Research Center
Atlanta, Georgia, 21286, United States
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Atlanta, Georgia, 30329, United States
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Atlanta, Georgia, 30342, United States
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Evansville, Indiana, 47714, United States
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Arkansas City, Kansas, 67005, United States
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Newton, Kansas, 67114, United States
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Wichita, Kansas, 67205, United States
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Louisville, Kentucky, 40291, United States
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Milford, Massachusetts, 01757, United States
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East Lansing, Michigan, 48910, United States
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Kalamazoo, Michigan, 49009, United States
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Lansing, Michigan, 48917, United States
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Flowood, Mississippi, 39232, United States
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Jackson, Mississippi, 39202, United States
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Bozeman, Montana, 59715, United States
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Las Vegas, Nevada, 89102, United States
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Berlin, New Jersey, 08009, United States
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Dover, New Jersey, 07801, United States
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Binghamton, New York, 13901, United States
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Manilus, New York, 13104, United States
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Rochester, New York, 14609, United States
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Durham, North Carolina, 27704, United States
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Winston-Salem, North Carolina, 27103, United States
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Cincinnati, Ohio, 45219, United States
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Cincinnati, Ohio, 45224, United States
Community Research Managment Associates
Cincinnati, Ohio, 45227, United States
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Cincinnati, Ohio, 45236, United States
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Columbus, Ohio, 43212, United States
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Columbus, Ohio, 43215, United States
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Franklin, Ohio, 45005, United States
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Perrysburg, Ohio, 43551, United States
Gilbert Medical Research
Bethany, Oklahoma, 73008, United States
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Beaver, Pennsylvania, 15009, United States
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Bensalem, Pennsylvania, 19020, United States
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Duncansville, Pennsylvania, 16635, United States
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Harleysville, Pennsylvania, 19438, United States
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Levittown, Pennsylvania, 19057, United States
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Penndel, Pennsylvania, 19047, United States
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Philadelphia, Pennsylvania, 19152, United States
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Pittsburgh, Pennsylvania, 15219, United States
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Warwick, Rhode Island, 02886, United States
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Anderson, South Carolina, 29621, United States
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Charleston, South Carolina, 29407, United States
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Columbia, South Carolina, 29204, United States
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Greer, South Carolina, 29651, United States
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Memphis, Tennessee, 38120, United States
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Austin, Texas, 78758, United States
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Dallas, Texas, 75231, United States
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Dallas, Texas, 75234, United States
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Dallas, Texas, 75235, United States
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Houston, Texas, 77024, United States
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Lake Jackson, Texas, 77566, United States
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San Antonio, Texas, 78209, United States
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San Antonio, Texas, 78217, United States
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Salt Lake City, Utah, 84102, United States
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Salt Lake City, Utah, 84124, United States
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Spokane, Washington, 99202, United States
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Spokane, Washington, 99207, United States
Unknown Facility
Glendale, Wisconsin, 53217, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
IDEA AG Clinical Trial
IDEA AG
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 13, 2005
First Posted
December 14, 2005
Study Start
July 1, 2005
Primary Completion
July 1, 2007
Last Updated
March 20, 2009
Record last verified: 2009-03