Hymovis Intra-articular Injection
DeviceHymovis Intra-articular injection
Other names: HYADD4™, Hyaluronic Acid, HA, Hyaluronate
NCT Number: NCT01372475
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.
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Notify Me40 year and older
All sexes
Interventional
Phase 3
Latin Clinical Trial Center, San Juan, Puerto Rico
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Hymovis Intra-articular injection
Other names: HYADD4™, Hyaluronic Acid, HA, Hyaluronate
Placebo Intra-articular injection
Other names: PBS, Saline
Time frame: 26 weeks
WOMAC A Pain sub-score
Time frame: 26 weeks
Outcome Measures in Rheumatoid Arthritis Clinical Trials - Osteoarthritis Research Society International (OMERACT-OARSI) Criteria
Time frame: 26 Weeks
WOMAC C Function sub-score
Time frame: 26 Weeks
Question A1 of WOMAC Pain sub-score
Time frame: 26 Weeks
Time frame: 26 Weeks
WOMAC C stiffness sub-score
Time frame: 26 Weeks
Time frame: 26 Weeks
Time frame: 26 Weeks
Time frame: 26 Weeks
Fidia Farmaceutici s.p.a.
Industry
A Multi-Centre, Double-Blind, Randomized, Placebo Controlled Study To Evaluate The Safety And Effectiveness Of A New Viscoelastic Hydrogel (Hymovis) In The Treatment Of Knee OA With An Open-Label Extension
Acronym: Hymovis
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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