An Effectiveness and Safety Study of IDEA-033 in Comparison to Oral Naproxen and Placebo for the Treatment of Osteoarthritis of the Knee
A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Three Doses 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
875
1 country
100
Brief Summary
The purpose of this study is to identify the dose(s) of IDEA-033 that will provide a meaningful effect for treating osteoarthritis of the knee.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
100 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedMarch 20, 2009
March 1, 2009
September 13, 2005
March 19, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline at Week 12 on pain subscale and physical function subscale on the WOMAC Osteoarthritis Index. Subject global assessment of response to therapy (SGART) on a five-point Likert scale at Week 12.
Secondary Outcomes (1)
Change from baseline at Weeks 2, 6, 9 for WOMAC pain and physical function scores and SGART. Mean change from baseline for the entire on-therapy period for WOMAC pain and physical function scores and SGART.
Interventions
Eligibility Criteria
You may qualify if:
- Osteoarthritis of both knees for minimum of six months
- 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
You may not qualify if:
- Grade 1 or Grade 4 severity of the most involved knee based on x-ray 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- IDEA AGlead
Study Sites (100)
Unknown Facility
Birmingham, Alabama, 35209, United States
Unknown Facility
Montgomery, Alabama, 36101, United States
Drug Research and Analysis Corporation
Montgomery, Alabama, 36124, United States
Unknown Facility
Northport, Alabama, 35476, United States
Unknown Facility
Mesa, Arizona, 85206, United States
Unknown Facility
Phoenix, Arizona, 85032, United States
Unknown Facility
Tempe, Arizona, 85258, United States
Unknown Facility
Anaheim, California, 92801, United States
Unknown Facility
Encinitas, California, 92024, United States
Unknown Facility
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
Unknown Facility
Temecula, California, 92591, United States
Unknown Facility
Vista, California, 92083, United States
Unknown Facility
Northglenn, Colorado, 80234, United States
Unknown Facility
Danbury, Connecticut, 06810, United States
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Clearwater, Florida, 33761, United States
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Coral Gables, Florida, 33134, United States
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Daytona Beach, Florida, 32114, United States
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DeLand, Florida, 32720, United States
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Fort Lauderdale, Florida, 33334, United States
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Fort Myers, Florida, 33916, United States
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Gainesville, Florida, 32607, United States
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Hialeah, Florida, 33013, United States
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Jacksonville, Florida, 32216, 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
Unknown Facility
Tampa, Florida, 33614, United States
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West Palm Beach, Florida, 33409, United States
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Atlanta, Georgia, 30329, United States
Unknown Facility
Atlanta, Georgia, 30342, United States
Unknown Facility
Evansville, Indiana, 47714, United States
Unknown Facility
Arkansas City, Kansas, 67005, United States
Unknown Facility
Kansas City, Kansas, 66109, 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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Towson, Maryland, 21286, 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
Unknown Facility
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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Kansas City, Missouri, 00000, United States
Unknown Facility
Bozeman, Montana, 59715, United States
Unknown Facility
Las Vegas, Nevada, 89102, United States
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Berlin, New Jersey, 08009, United States
Unknown Facility
Dover, New Jersey, 07801, United States
Unknown Facility
Binghamton, New York, 13901, United States
Unknown Facility
Manilus, New York, 13104, United States
Unknown Facility
Rochester, New York, 14609, United States
Unknown Facility
Durham, North Carolina, 27704, United States
Cumberland Research Associates L L C
Fayetteville, North Carolina, 28304, United States
Unknown Facility
Wilmington, North Carolina, 28412, United States
Unknown Facility
Winston-Salem, North Carolina, 27103, United States
Unknown Facility
Cincinnati, Ohio, 45219, United States
Unknown Facility
Cincinnati, Ohio, 45224, United States
Community Research Managment Associates
Cincinnati, Ohio, 45227, United States
Unknown Facility
Cincinnati, Ohio, 45236, United States
Unknown Facility
Colombus, Ohio, 43215, United States
Unknown Facility
Columbus, Ohio, 43212, United States
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Franklin, Ohio, 45005, United States
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Perrysburg, Ohio, 43551, United States
Unknown Facility
Bethany, Oklahoma, 73008, United States
Unknown Facility
Beaver, Pennsylvania, 15009, United States
Unknown Facility
Bensalem, Pennsylvania, 19020, United States
Unknown Facility
Duncansville, Pennsylvania, 16635, United States
Unknown Facility
Harleysville, Pennsylvania, 19438, United States
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Levittown, Pennsylvania, 19057, United States
Unknown Facility
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
Unknown Facility
Anderson, South Carolina, 29621, United States
Unknown Facility
Charleston, South Carolina, 29407, United States
Unknown Facility
Columbia, South Carolina, 29204, United States
Unknown Facility
Greer, South Carolina, 29651, United States
Unknown Facility
Memphis, Tennessee, 38120, United States
Unknown Facility
Austin, Texas, 78758, United States
Unknown Facility
Dallas, Texas, 75231, United States
Unknown Facility
Dallas, Texas, 75234, United States
Unknown Facility
Dallas, Texas, 75235, United States
Unknown Facility
Houston, Texas, 77024, United States
Unknown Facility
Lake Jackson, Texas, 77566, United States
Unknown Facility
San Antonio, Texas, 78209, United States
Unknown Facility
San Antonio, Texas, 78217, United States
Unknown Facility
Salt Lake City, Utah, 84102, United States
Unknown Facility
Salt Lake City, Utah, 84124, United States
Unknown Facility
Spokane, Washington, 99202, United States
Unknown Facility
Spokane, Washington, 99207, United States
Unknown Facility
Glendale, Wisconsin, 53217, United States
MeSH Terms
Conditions
Condition 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
September 13, 2005
First Posted
September 21, 2005
Study Start
June 1, 2005
Last Updated
March 20, 2009
Record last verified: 2009-03