Hymovis™ Versus Placebo in Knee Osteoarthritis

Status: Completed
Study State Date: March 2011
Primary Completion Date: Actual November 2012
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Phase: Phase 3

Sponsor(s):
Fidia Farmaceutici s.p.a.
 
Information By: Fidia Farmaceutici s.p.a.
Trial Identifier: NCT01372475
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

Description:  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.

Accepts Healthy Volunteers?: No
Enrollment: 800 Actual
Minimum Age: 40 Years
Maximum Age: N/A
Gender(s): Both
Additional Criteria:  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

Conditions:
Osteoarthritis
Osteoarthritis, Knee
Knee Osteoarthritis
Interventions:
Device: Hymovis Intra-articular Injection
Procedure: Phosphate Buffered Saline Injection
 
Primary Outcome Measures:
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain sub-score
Time Frame: 26 weeks
Safety Issue: No

 
Secondary Outcome Measures:
Responder Analysis
Time Frame: 26 weeks
Safety Issue: No

WOMAC Function
Time Frame: 26 Weeks
Safety Issue: No

Visual Analog Scale (VAS) WOMAC Pain
Time Frame: 26 Weeks
Safety Issue: No

WOMAC Global Score
Time Frame: 26 Weeks
Safety Issue: No

WOMAC Stiffness sub-score
Time Frame: 26 Weeks
Safety Issue: No

Rescue Medication Usage Pill Count, Failure Outcome
Time Frame: 26 Weeks
Safety Issue: No

Patient Global Analysis
Time Frame: 26 Weeks
Safety Issue: No

Clinician Responder Analysis
Time Frame: 26 Weeks
Safety Issue: No

SF Health Outcome
Time Frame: 26 Weeks
Safety Issue: No

 
Patient Groups:
Assigned Interventions:

Hymovis Viscoelastic Hydrogel: Active Comparator
Intra-articular Injection
Device: Hymovis Intra-articular Injection
Hymovis Intra-articular injection

 
Placebo: Placebo Comparator
Phosphate Buffered Saline Intra-articular Injection
Procedure: Phosphate Buffered Saline Injection
Placebo Intra-articular injection

 


Investigators:
Study Director: Cynthia Secchieri, PhD, Fidia Farmceutici S.p.A.


Study Locations:
+ Show All 33 Study Locations


United States, Alabama
Achieve Clinical Research, LLC 
Birmingham, Alabama, United States



United States, Arizona
Tucson Orthopaedic Institute 
Tucson, Arizona, United States



United States, California
Core Orthopaedic 
Encinitas, California, United States

San Diego Clinical Trials 
San Diego, California, United States



United States, Connecticut
Norwalk Medical Group 
Norwalk, Connecticut, United States

Stamford Therapeutics Consortium 
Stamford, Connecticut, United States



United States, Florida
Tampa Bay Medical Research 
Clearwater, Florida, United States

Homestead Clinical Research 
Cutler Bay, Florida, United States

SJS Clinical Research 
DeFuniak Springs, Florida, United States

Avail Clinical Research 
Deland, Florida, United States

Riverside Clinical Research 
Edgewater, Florida, United States

The Andrews Institute 
Gulf Breeze, Florida, United States

Sun Coast Clinical Research 
New Port Richey, Florida, United States

Pensacola Research Consultants 
Pensacola, Florida, United States

Lakeview Medical Research 
Summerfield, Florida, United States



United States, Georgia
Drug Studies America 
Marietta, Georgia, United States

Better Health Clinical Research 
Newnan, Georgia, United States



United States, Idaho
Sonora Clinical Research 
Boise, Idaho, United States



United States, Illinois
Rush University 
Chicago, Illinois, United States



United States, Louisiana
Benchmark Research 
Metairie, Louisiana, United States



United States, Massachusetts
UMass Memorial Medical Center 
Worcester, Massachusetts, United States



United States, Michigan
Shores Rheumatology 
St. Clair Shores, Michigan, United States



United States, Ohio
Columbus Clinical Research 
Columbus, Ohio, United States

Radiant Research 
Columbus, Ohio, United States



United States, Pennsylvania
Blair Orthopedics Associates & Sports Medicine 
Altoona, Pennsylvania, United States

Altoona Center for Clinical Research 
Duncansville, Pennsylvania, United States

University Orthopedic Center 
State College, Pennsylvania, United States



United States, South Carolina
Radiant Research 
Anderson, South Carolina, United States

Radiant Research 
Greer, South Carolina, United States



United States, Texas
Tekton Research 
Austin, Texas, United States

Martin Diagnostic Center 
Tomball, Texas, United States



United States, Washington
Orthopaedic Specialty Clinic 
Spokane, Washington, United States



Puerto Rico
Latin Clinical Trial Center 
San Juan, Puerto Rico

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