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
1 other identifier
interventional
800
2 countries
33
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 knee-osteoarthritis
Started Mar 2011
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 10, 2011
CompletedFirst Posted
Study publicly available on registry
June 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedApril 8, 2014
March 1, 2014
1.7 years
June 10, 2011
March 11, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain sub-score
WOMAC A Pain sub-score
26 weeks
Secondary Outcomes (9)
Responder Analysis
26 weeks
WOMAC Function
26 Weeks
Visual Analog Scale (VAS) WOMAC Pain
26 Weeks
WOMAC Global Score
26 Weeks
WOMAC Stiffness sub-score
26 Weeks
- +4 more secondary outcomes
Study Arms (2)
Hymovis Viscoelastic Hydrogel
ACTIVE COMPARATORIntra-articular Injection
Placebo
PLACEBO COMPARATORPhosphate Buffered Saline Intra-articular Injection
Interventions
Hymovis Intra-articular injection
Placebo Intra-articular injection
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Achieve Clinical Research, LLC
Birmingham, Alabama, United States
Tucson Orthopaedic Institute
Tucson, Arizona, United States
Core Orthopaedic
Encinitas, California, United States
San Diego Clinical Trials
San Diego, California, United States
Norwalk Medical Group
Norwalk, Connecticut, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, United States
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
Drug Studies America
Marietta, Georgia, United States
Better Health Clinical Research
Newnan, Georgia, United States
Sonora Clinical Research
Boise, Idaho, United States
Rush University
Chicago, Illinois, United States
Benchmark Research
Metairie, Louisiana, United States
UMass Memorial Medical Center
Worcester, Massachusetts, United States
Shores Rheumatology
Saint Clair Shores, Michigan, United States
Columbus Clinical Research
Columbus, Ohio, United States
Radiant Research
Columbus, Ohio, United States
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
Radiant Research
Anderson, South Carolina, United States
Radiant Research
Greer, South Carolina, United States
Tekton Research
Austin, Texas, United States
Martin Diagnostic Center
Tomball, Texas, United States
Orthopaedic Specialty Clinic
Spokane, Washington, United States
Latin Clinical Trial Center
San Juan, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Cynthia Secchieri, PhD
Fidia Farmceutici S.p.A.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2011
First Posted
June 14, 2011
Study Start
March 1, 2011
Primary Completion
November 1, 2012
Study Completion
February 1, 2013
Last Updated
April 8, 2014
Record last verified: 2014-03