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
800 participants
INTERVENTIONAL
2011-03-31
2013-02-28
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
TRIPLE
Study Groups
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Hymovis Viscoelastic Hydrogel
Intra-articular Injection
Hymovis Intra-articular Injection
Hymovis Intra-articular injection
Placebo
Phosphate Buffered Saline Intra-articular Injection
Phosphate Buffered Saline Injection
Placebo Intra-articular injection
Interventions
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Hymovis Intra-articular Injection
Hymovis Intra-articular injection
Phosphate Buffered Saline Injection
Placebo Intra-articular injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Has a medical history of OA symptoms confirmed at least 3 months prior to the screening visit with radiographic evidence of OA, Kellgren-Lawrence grade 2-3
3. Discontinuation of any analgesic/NSAID therapy prior to baseline with no intent to resume during study
Exclusion Criteria
2. Clinically significant valgus/varus deformities, ligamentous laxity or meniscal instability as assessed by the Investigator;
3. Any musculoskeletal condition affecting the target knee that would impair assessment of the effectiveness in the target knee such as Paget's disease
4. Medical history of anaphylactic reactions
5. History of septic arthritis in any joint
6. Females who are pregnant or breast-feeding
40 Years
ALL
No
Sponsors
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Fidia Farmaceutici s.p.a.
INDUSTRY
Responsible Party
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Principal Investigators
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Cynthia Secchieri, PhD
Role: STUDY_DIRECTOR
Fidia Farmceutici S.p.A.
Locations
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Achieve Clinical Research, LLC
Birmingham, Alabama, United States
Tucson Orthopaedic Institute
Tucson, Arizona, United States
Core Orthopaedic
Encinitas, California, United States
San Diego Clinical Trials
San Diego, California, United States
Norwalk Medical Group
Norwalk, Connecticut, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, United States
Tampa Bay Medical Research
Clearwater, Florida, United States
Homestead Clinical Research
Cutler Bay, Florida, United States
SJS Clinical Research
DeFuniak Springs, Florida, United States
Avail Clinical Research
DeLand, Florida, United States
Riverside Clinical Research
Edgewater, Florida, United States
The Andrews Institute
Gulf Breeze, Florida, United States
Sun Coast Clinical Research
New Port Richey, Florida, United States
Pensacola Research Consultants
Pensacola, Florida, United States
Lakeview Medical Research
Summerfield, Florida, United States
Drug Studies America
Marietta, Georgia, United States
Better Health Clinical Research
Newnan, Georgia, United States
Sonora Clinical Research
Boise, Idaho, United States
Rush University
Chicago, Illinois, United States
Benchmark Research
Metairie, Louisiana, United States
UMass Memorial Medical Center
Worcester, Massachusetts, United States
Shores Rheumatology
Saint Clair Shores, Michigan, United States
Columbus Clinical Research
Columbus, Ohio, United States
Radiant Research
Columbus, Ohio, United States
Blair Orthopedics Associates & Sports Medicine
Altoona, Pennsylvania, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
University Orthopedic Center
State College, Pennsylvania, United States
Radiant Research
Anderson, South Carolina, United States
Radiant Research
Greer, South Carolina, United States
Tekton Research
Austin, Texas, United States
Martin Diagnostic Center
Tomball, Texas, United States
Orthopaedic Specialty Clinic
Spokane, Washington, United States
Latin Clinical Trial Center
San Juan, , Puerto Rico
Countries
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Other Identifiers
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R29-09-02
Identifier Type: -
Identifier Source: org_study_id
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