Hymovis™ Versus Placebo in Knee Osteoarthritis

Completed · Phase 3 · Has a placebo group

Conditions studied: Knee Osteoarthritis

In brief

Purpose: The purpose of this study is to demonstrate if the intra-articular injection of a new viscoelastic Hydrogel (Hymovis) is superior to Placebo (phosphate buffered saline \[PBS\] in subjects with symptomatic osteoarthritis of the knee.

Key facts

Study ID

NCT01372475

Run by

Fidia Farmaceutici s.p.a.

People needed

800

Starts

2011-03-01

Expected to finish

2013-02-01

Last updated by the study team

2014-04-08

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female ambulant outpatients ≥ 40 years of age with an active lifestyle:
• 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
• Discontinuation of any analgesic/NSAID therapy prior to baseline with no intent to resume during study

You may not qualify if…

• Clinically significant apparent large effusion of the target knee;
• Clinically significant valgus/varus deformities, ligamentous laxity or meniscal instability as assessed by the Investigator;
• Any musculoskeletal condition affecting the target knee that would impair assessment of the effectiveness in the target knee such as Paget's disease
• Medical history of anaphylactic reactions
• History of septic arthritis in any joint
• Females who are pregnant or breast-feeding

Where it is running

• 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

Full record on ClinicalTrials.gov

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