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Hymovis™ Versus Placebo in Knee Osteoarthritis (Hymovis)

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Hymovis Intra-articular Injection
Phosphate Buffered Saline Injection
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 Osteoarthritis, Knee, Hyaluronan, Hyaluronic Acid, Viscoelastic, Hydrogel

Eligibility Criteria

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

Inclusion Criteria:

  1. Male or female ambulant outpatients ≥ 40 years of age with an active lifestyle:
  2. Has a medical history of OA symptoms confirmed at least 3 months prior to the screening visit with radiographic evidence of OA, Kellgren-Lawrence grade 2-3
  3. Discontinuation of any analgesic/NSAID therapy prior to baseline with no intent to resume during study

Exclusion Criteria:

  1. Clinically significant apparent large effusion of the target knee;
  2. Clinically significant valgus/varus deformities, ligamentous laxity or meniscal instability as assessed by the Investigator;
  3. Any musculoskeletal condition affecting the target knee that would impair assessment of the effectiveness in the target knee such as Paget's disease
  4. Medical history of anaphylactic reactions
  5. History of septic arthritis in any joint
  6. Females who are pregnant or breast-feeding

Sites / Locations

  • Achieve Clinical Research, LLC
  • Tucson Orthopaedic Institute
  • Core Orthopaedic
  • San Diego Clinical Trials
  • Norwalk Medical Group
  • Stamford Therapeutics Consortium
  • Tampa Bay Medical Research
  • Homestead Clinical Research
  • SJS Clinical Research
  • Avail Clinical Research
  • Riverside Clinical Research
  • The Andrews Institute
  • Sun Coast Clinical Research
  • Pensacola Research Consultants
  • Lakeview Medical Research
  • Drug Studies America
  • Better Health Clinical Research
  • Sonora Clinical Research
  • Rush University
  • Benchmark Research
  • UMass Memorial Medical Center
  • Shores Rheumatology
  • Columbus Clinical Research
  • Radiant Research
  • Blair Orthopedics Associates & Sports Medicine
  • Altoona Center for Clinical Research
  • University Orthopedic Center
  • Radiant Research
  • Radiant Research
  • Tekton Research
  • Martin Diagnostic Center
  • Orthopaedic Specialty Clinic
  • Latin Clinical Trial Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Hymovis Viscoelastic Hydrogel

Placebo

Arm Description

Intra-articular Injection

Phosphate Buffered Saline Intra-articular Injection

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Responder Analysis
Outcome Measures in Rheumatoid Arthritis Clinical Trials - Osteoarthritis Research Society International (OMERACT-OARSI) Criteria
WOMAC Function
WOMAC C Function sub-score
Visual Analog Scale (VAS) WOMAC Pain
Question A1 of WOMAC Pain sub-score
WOMAC Global Score
WOMAC Stiffness sub-score
WOMAC C stiffness sub-score
Rescue Medication Usage Pill Count, Failure Outcome
Patient Global Analysis
Clinician Responder Analysis
SF Health Outcome

Full Information

First Posted
June 10, 2011
Last Updated
March 11, 2014
Sponsor
Fidia Farmaceutici s.p.a.
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1. Study Identification

Unique Protocol Identification Number
NCT01372475
Brief Title
Hymovis™ Versus Placebo in Knee Osteoarthritis
Acronym
Hymovis
Official Title
A Multi-Centre, Double-Blind, Randomized, Placebo Controlled Study To Evaluate The Safety And Effectiveness Of A New Viscoelastic Hydrogel (Hymovis) In The Treatment Of Knee OA With An Open-Label Extension
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
February 2013 (Actual)

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
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
800 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hymovis Viscoelastic Hydrogel
Arm Type
Active Comparator
Arm Description
Intra-articular Injection
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Phosphate Buffered Saline Intra-articular Injection
Intervention Type
Device
Intervention Name(s)
Hymovis Intra-articular Injection
Other Intervention Name(s)
HYADD4™, Hyaluronic Acid, HA, Hyaluronate
Intervention Description
Hymovis Intra-articular injection
Intervention Type
Procedure
Intervention Name(s)
Phosphate Buffered Saline Injection
Other Intervention Name(s)
PBS, Saline
Intervention Description
Placebo Intra-articular injection
Primary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain sub-score
Description
WOMAC A Pain sub-score
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Responder Analysis
Description
Outcome Measures in Rheumatoid Arthritis Clinical Trials - Osteoarthritis Research Society International (OMERACT-OARSI) Criteria
Time Frame
26 weeks
Title
WOMAC Function
Description
WOMAC C Function sub-score
Time Frame
26 Weeks
Title
Visual Analog Scale (VAS) WOMAC Pain
Description
Question A1 of WOMAC Pain sub-score
Time Frame
26 Weeks
Title
WOMAC Global Score
Time Frame
26 Weeks
Title
WOMAC Stiffness sub-score
Description
WOMAC C stiffness sub-score
Time Frame
26 Weeks
Title
Rescue Medication Usage Pill Count, Failure Outcome
Time Frame
26 Weeks
Title
Patient Global Analysis
Time Frame
26 Weeks
Title
Clinician Responder Analysis
Time Frame
26 Weeks
Title
SF Health Outcome
Time Frame
26 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female ambulant outpatients ≥ 40 years of age with an active lifestyle: Has a medical history of OA symptoms confirmed at least 3 months prior to the screening visit with radiographic evidence of OA, Kellgren-Lawrence grade 2-3 Discontinuation of any analgesic/NSAID therapy prior to baseline with no intent to resume during study Exclusion Criteria: Clinically significant apparent large effusion of the target knee; Clinically significant valgus/varus deformities, ligamentous laxity or meniscal instability as assessed by the Investigator; Any musculoskeletal condition affecting the target knee that would impair assessment of the effectiveness in the target knee such as Paget's disease Medical history of anaphylactic reactions History of septic arthritis in any joint Females who are pregnant or breast-feeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Secchieri, PhD
Organizational Affiliation
Fidia Farmceutici S.p.A.
Official's Role
Study Director
Facility Information:
Facility Name
Achieve Clinical Research, LLC
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Tucson Orthopaedic Institute
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
Core Orthopaedic
City
Encinitas
State/Province
California
Country
United States
Facility Name
San Diego Clinical Trials
City
San Diego
State/Province
California
Country
United States
Facility Name
Norwalk Medical Group
City
Norwalk
State/Province
Connecticut
Country
United States
Facility Name
Stamford Therapeutics Consortium
City
Stamford
State/Province
Connecticut
Country
United States
Facility Name
Tampa Bay Medical Research
City
Clearwater
State/Province
Florida
Country
United States
Facility Name
Homestead Clinical Research
City
Cutler Bay
State/Province
Florida
Country
United States
Facility Name
SJS Clinical Research
City
DeFuniak Springs
State/Province
Florida
Country
United States
Facility Name
Avail Clinical Research
City
Deland
State/Province
Florida
Country
United States
Facility Name
Riverside Clinical Research
City
Edgewater
State/Province
Florida
Country
United States
Facility Name
The Andrews Institute
City
Gulf Breeze
State/Province
Florida
Country
United States
Facility Name
Sun Coast Clinical Research
City
New Port Richey
State/Province
Florida
Country
United States
Facility Name
Pensacola Research Consultants
City
Pensacola
State/Province
Florida
Country
United States
Facility Name
Lakeview Medical Research
City
Summerfield
State/Province
Florida
Country
United States
Facility Name
Drug Studies America
City
Marietta
State/Province
Georgia
Country
United States
Facility Name
Better Health Clinical Research
City
Newnan
State/Province
Georgia
Country
United States
Facility Name
Sonora Clinical Research
City
Boise
State/Province
Idaho
Country
United States
Facility Name
Rush University
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Benchmark Research
City
Metairie
State/Province
Louisiana
Country
United States
Facility Name
UMass Memorial Medical Center
City
Worcester
State/Province
Massachusetts
Country
United States
Facility Name
Shores Rheumatology
City
St. Clair Shores
State/Province
Michigan
Country
United States
Facility Name
Columbus Clinical Research
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Radiant Research
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Blair Orthopedics Associates & Sports Medicine
City
Altoona
State/Province
Pennsylvania
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
Country
United States
Facility Name
University Orthopedic Center
City
State College
State/Province
Pennsylvania
Country
United States
Facility Name
Radiant Research
City
Anderson
State/Province
South Carolina
Country
United States
Facility Name
Radiant Research
City
Greer
State/Province
South Carolina
Country
United States
Facility Name
Tekton Research
City
Austin
State/Province
Texas
Country
United States
Facility Name
Martin Diagnostic Center
City
Tomball
State/Province
Texas
Country
United States
Facility Name
Orthopaedic Specialty Clinic
City
Spokane
State/Province
Washington
Country
United States
Facility Name
Latin Clinical Trial Center
City
San Juan
Country
Puerto Rico

12. IPD Sharing Statement

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Hymovis™ Versus Placebo in Knee Osteoarthritis

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