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Safety and Effectiveness Study of a Non-Crosslinked HA Alkylamide HYADD(TM) 4 Hydrogel for Osteoarthritis of the Knee

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02187549
Enrollment
332
Registered
2014-07-11
Start date
2014-06-30
Completion date
2016-03-31
Last updated
2015-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Keywords

Hyaluronic Acid, Osteoarthritis, Knee, Hyaluronan, Viscoelastic, Hydrogel

Brief summary

The purpose of this study is to determine whether intra-articular hyaluronic acid provides symptomatic relief of osteoarthritis of the knee.

Interventions

DEVICEHYMOVIS

Intra-articular injection

DEVICEPlacebo

Intra-Articular Injection

Sponsors

Fidia Farmaceutici s.p.a.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Symptomatic osteoarthritis of the knee.

Exclusion criteria

* No disorders which could interfere with study required assessments.

Design outcomes

Primary

MeasureTime frame
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Sub-score26 weeks

Secondary

MeasureTime frame
Patient Global Assessment26 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026