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NCT02187549 Clinical Trial

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

Knee Osteoarthritis Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02187549
Other study ID # EQE7-13-01
Secondary ID
Status Active, not recruiting
Phase N/A
First received June 29, 2014
Last updated October 2, 2015
Start date June 2014
Est. completion date March 2016

Study information
Verified date October 2015
Source Fidia Farmaceutici s.p.a.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 332
Est. completion date March 2016
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender Both
Age group 40 Years and older
Eligibility Inclusion Criteria:

- Symptomatic osteoarthritis of the knee.

Exclusion Criteria:

- No disorders which could interfere with study required assessments.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• HYMOVIS
Intra-articular injection
• Placebo
Intra-Articular Injection

Locations
Country Name City State
United States Blair Orphopedics Altoona Pennsylvania
United States Great Lakes Research Group Bay City Michigan
United States Achieve Clinical Research Birmingham Alabama
United States Tufts Medical Center Boston Massachusetts
United States Alabama Clinical Therapeutics Brimingham Alabama
United States Med Center Carmichael California
United States New Horizons Cincinnati Ohio
United States Columbus Clinical Research Columbus Ohio
United States Riverside Clinical Research Edgewater Florida
United States Fabio Orozco Egg Harbor Township New Jersey
United States Triwest Research Associates El Cajon California
United States Colorado Orthopedic Consultants Englewood Colorado
United States Healthcare Research Network Hazelwood Missouri
United States West Houston Clinical Research Houston Texas
United States Suncoast Clinical Research New Port Richey Florida
United States Ormond Medical Arts Ormond Beach Florida
United States Arizona Research Center Phoenix Arizona
United States Elite Clinical Studies Phoenix Arizona
United States PMG Research of Raleigh Raleigh North Carolina
United States Westlake Medical Thousand Oaks California
United States Chase Medical Waterbury Connecticut

Sponsors (1)
Lead Sponsor Collaborator
Fidia Farmaceutici s.p.a.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Sub-score 26 weeks No
Secondary Patient Global Assessment 26 weeks No
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