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

Primary Purpose

Knee Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HYMOVIS
Placebo
Sponsored by
Fidia Farmaceutici s.p.a.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Hyaluronic Acid, Osteoarthritis, Knee, Hyaluronan, Viscoelastic, Hydrogel

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Symptomatic osteoarthritis of the knee.

Exclusion Criteria:

  • No disorders which could interfere with study required assessments.

Sites / Locations

  • Achieve Clinical Research
  • Alabama Clinical Therapeutics
  • Elite Clinical Studies
  • Arizona Research Center
  • Med Center
  • Triwest Research Associates
  • Westlake Medical
  • Colorado Orthopedic Consultants
  • Chase Medical
  • Riverside Clinical Research
  • Suncoast Clinical Research
  • Ormond Medical Arts
  • Tufts Medical Center
  • Great Lakes Research Group
  • Healthcare Research Network
  • Fabio Orozco
  • PMG Research of Raleigh
  • New Horizons
  • Columbus Clinical Research
  • Blair Orphopedics
  • West Houston Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HYMOVIS

Placebo

Arm Description

HYADD(TM) 4 Hydrogel Intra-Articular Injection

Saline Intra-Articular Injection

Outcomes

Primary Outcome Measures

Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Sub-score

Secondary Outcome Measures

Patient Global Assessment

Full Information

First Posted
June 29, 2014
Last Updated
October 2, 2015
Sponsor
Fidia Farmaceutici s.p.a.
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1. Study Identification

Unique Protocol Identification Number
NCT02187549
Brief Title
Safety and Effectiveness Study of a Non-Crosslinked HA Alkylamide HYADD(TM) 4 Hydrogel for Osteoarthritis of the Knee
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
March 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fidia Farmaceutici s.p.a.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Hyaluronic Acid, Osteoarthritis, Knee, Hyaluronan, Viscoelastic, Hydrogel

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
332 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HYMOVIS
Arm Type
Experimental
Arm Description
HYADD(TM) 4 Hydrogel Intra-Articular Injection
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline Intra-Articular Injection
Intervention Type
Device
Intervention Name(s)
HYMOVIS
Other Intervention Name(s)
HYADD(TM) 4 Hydrogel Intra-Articular Injection
Intervention Description
Intra-articular injection
Intervention Type
Device
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo Intra-Articular Injection
Intervention Description
Intra-Articular Injection
Primary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Sub-score
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Patient Global Assessment
Time Frame
26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Symptomatic osteoarthritis of the knee. Exclusion Criteria: No disorders which could interfere with study required assessments.
Facility Information:
Facility Name
Achieve Clinical Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Alabama Clinical Therapeutics
City
Brimingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
Elite Clinical Studies
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Med Center
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
Triwest Research Associates
City
El Cajon
State/Province
California
ZIP/Postal Code
92020
Country
United States
Facility Name
Westlake Medical
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Facility Name
Colorado Orthopedic Consultants
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80110
Country
United States
Facility Name
Chase Medical
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Riverside Clinical Research
City
Edgewater
State/Province
Florida
ZIP/Postal Code
32132
Country
United States
Facility Name
Suncoast Clinical Research
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Ormond Medical Arts
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Great Lakes Research Group
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Facility Name
Healthcare Research Network
City
Hazelwood
State/Province
Missouri
ZIP/Postal Code
63042
Country
United States
Facility Name
Fabio Orozco
City
Egg Harbor Township
State/Province
New Jersey
ZIP/Postal Code
08234
Country
United States
Facility Name
PMG Research of Raleigh
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
New Horizons
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Columbus Clinical Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Blair Orphopedics
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
West Houston Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77055
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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