Hymovis™ Versus Placebo in Knee Osteoarthritis (Hymovis)

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

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: Hymovis Intra-articular Injection; Procedure: Phosphate Buffered Saline Injection

• Study Type: Interventional
• Enrollment (Actual): 800
• Phase: Phase 3

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico
    • Latin Clinical Trial Center
• United States
  • Alabama
    • Birmingham, Alabama, United States
      • Achieve Clinical Research, LLC
  • Arizona
    • Tucson, Arizona, United States
      • Tucson Orthopaedic Institute
  • California
    • Encinitas, California, United States
      • Core Orthopaedic
    • San Diego, California, United States
      • San Diego Clinical Trials
  • Connecticut
    • Norwalk, Connecticut, United States
      • Norwalk Medical Group
    • Stamford, Connecticut, United States
      • Stamford Therapeutics Consortium
  • Florida
    • Clearwater, Florida, United States
      • Tampa Bay Medical Research
    • Cutler Bay, Florida, United States
      • Homestead Clinical Research
    • DeFuniak Springs, Florida, United States
      • Sjs Clinical Research
    • Deland, Florida, United States
      • Avail Clinical Research
    • Edgewater, Florida, United States
      • Riverside Clinical Research
    • Gulf Breeze, Florida, United States
      • The Andrews Institute
    • New Port Richey, Florida, United States
      • Sun Coast Clinical Research
    • Pensacola, Florida, United States
      • Pensacola Research Consultants
    • Summerfield, Florida, United States
      • Lakeview Medical Research
  • Georgia
    • Marietta, Georgia, United States
      • Drug Studies America
    • Newnan, Georgia, United States
      • Better Health Clinical Research
  • Idaho
    • Boise, Idaho, United States
      • Sonora Clinical Research
  • Illinois
    • Chicago, Illinois, United States
      • Rush University
  • Louisiana
    • Metairie, Louisiana, United States
      • Benchmark Research
  • Massachusetts
    • Worcester, Massachusetts, United States
      • UMass Memorial Medical Center
  • Michigan
    • St. Clair Shores, Michigan, United States
      • Shores Rheumatology
  • Ohio
    • Columbus, Ohio, United States
      • Columbus Clinical Research
    • Columbus, Ohio, United States
      • Radiant Research
  • Pennsylvania
    • Altoona, Pennsylvania, United States
      • Blair Orthopedics Associates & Sports Medicine
    • Duncansville, Pennsylvania, United States
      • Altoona Center For Clinical Research
    • State College, Pennsylvania, United States
      • University Orthopedic Center
  • South Carolina
    • Anderson, South Carolina, United States
      • Radiant Research
    • Greer, South Carolina, United States
      • Radiant Research
  • Texas
    • Austin, Texas, United States
      • Tekton Research
    • Tomball, Texas, United States
      • Martin Diagnostic Center
  • Washington
    • Spokane, Washington, United States
      • Orthopaedic Specialty Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hymovis Viscoelastic Hydrogel; Intra-articular Injection	Device: Hymovis Intra-articular Injection; Hymovis Intra-articular injection; Other Names: Hyaluronic Acid; HA; HYADD4™; Hyaluronate
Placebo Comparator: Placebo; Phosphate Buffered Saline Intra-articular Injection	Procedure: Phosphate Buffered Saline Injection; Placebo Intra-articular injection; Other Names: Saline; PBS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain sub-score	WOMAC A Pain sub-score	26 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responder Analysis	Outcome Measures in Rheumatoid Arthritis Clinical Trials - Osteoarthritis Research Society International (OMERACT-OARSI) Criteria	26 weeks
WOMAC Function	WOMAC C Function sub-score	26 Weeks
Visual Analog Scale (VAS) WOMAC Pain	Question A1 of WOMAC Pain sub-score	26 Weeks
WOMAC Global Score		26 Weeks
WOMAC Stiffness sub-score	WOMAC C stiffness sub-score	26 Weeks
Rescue Medication Usage Pill Count, Failure Outcome		26 Weeks
Patient Global Analysis		26 Weeks
Clinician Responder Analysis		26 Weeks
SF Health Outcome		26 Weeks

Collaborators and Investigators

• Sponsor: Fidia Farmaceutici s.p.a.
• Investigators: Study Director: Cynthia Secchieri, PhD, Fidia Farmceutici S.p.A.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: June 10, 2011
• First Submitted That Met QC Criteria: June 13, 2011
• First Posted (Estimate): June 14, 2011

Study Record Updates

• Last Update Posted (Estimate): April 8, 2014
• Last Update Submitted That Met QC Criteria: March 11, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Osteoarthritis; Knee; Hyaluronic Acid; Hyaluronan; Hydrogel; Viscoelastic
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: R29-09-02