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

October 2, 2015 updated by: Fidia Farmaceutici s.p.a.
The purpose of this study is to determine whether intra-articular hyaluronic acid provides symptomatic relief of osteoarthritis of the knee.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

332

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Achieve Clinical Research
      • Brimingham, Alabama, United States, 35235
        • Alabama Clinical Therapeutics
    • Arizona
      • Phoenix, Arizona, United States, 85023
        • Arizona Research Center
      • Phoenix, Arizona, United States, 85018
        • Elite Clinical Studies
    • California
      • Carmichael, California, United States, 95608
        • Med Center
      • El Cajon, California, United States, 92020
        • Triwest Research Associates
      • Thousand Oaks, California, United States, 91360
        • Westlake Medical
    • Colorado
      • Englewood, Colorado, United States, 80110
        • Colorado Orthopedic Consultants
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Chase Medical
    • Florida
      • Edgewater, Florida, United States, 32132
        • Riverside Clinical Research
      • New Port Richey, Florida, United States, 34652
        • Suncoast Clinical Research
      • Ormond Beach, Florida, United States, 32174
        • Ormond Medical Arts
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
    • Michigan
      • Bay City, Michigan, United States, 48706
        • Great Lakes Research Group
    • Missouri
      • Hazelwood, Missouri, United States, 63042
        • Healthcare Research Network
    • New Jersey
      • Egg Harbor Township, New Jersey, United States, 08234
        • Fabio Orozco
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • PMG Research of Raleigh
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • New Horizons
      • Columbus, Ohio, United States, 43213
        • Columbus Clinical Research
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Blair Orphopedics
    • Texas
      • Houston, Texas, United States, 77055
        • West Houston Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Symptomatic osteoarthritis of the knee.

Exclusion Criteria:

  • No disorders which could interfere with study required assessments.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HYMOVIS
HYADD(TM) 4 Hydrogel Intra-Articular Injection
Device: HYMOVIS
Intra-articular injection
Other Names:
  • HYADD(TM) 4 Hydrogel Intra-Articular Injection
Placebo Comparator: Placebo
Saline Intra-Articular Injection
Device: Placebo
Intra-Articular Injection
Other Names:
  • Placebo Intra-Articular Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Sub-score
Time Frame: 26 weeks
26 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient Global Assessment
Time Frame: 26 weeks
26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fidia Farmaceutici s.p.a.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

February 1, 2016

Study Completion (Anticipated)

March 1, 2016

Study Registration Dates

First Submitted

June 29, 2014

First Submitted That Met QC Criteria

July 9, 2014

First Posted (Estimate)

July 11, 2014

Study Record Updates

Last Update Posted (Estimate)

October 5, 2015

Last Update Submitted That Met QC Criteria

October 2, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EQE7-13-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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