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Viscosupplementation Agent
Hymovis Viscoelastic Hydrogel for Osteoarthritis (Hymovis Trial)
Phase 3
Waitlist Available
Research Sponsored by Fidia Farmaceutici s.p.a.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 26 weeks
Awards & highlights
Summary
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.
Eligible Conditions
- Osteoarthritis
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 26 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain sub-score
Secondary study objectives
Responder Analysis
Visual Analog Scale (VAS) WOMAC Pain
WOMAC Function
+1 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Hymovis Viscoelastic HydrogelActive Control1 Intervention
Intra-articular Injection
Group II: PlaceboPlacebo Group1 Intervention
Phosphate Buffered Saline Intra-articular Injection
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Who is running the clinical trial?
Fidia Farmaceutici s.p.a.Lead Sponsor
33 Previous Clinical Trials
4,042 Total Patients Enrolled
6 Trials studying Osteoarthritis
1,066 Patients Enrolled for Osteoarthritis
Cynthia Secchieri, PhDStudy DirectorFidia Farmceutici S.p.A.
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