Clinical trial NCT01372475: Hymovis™ Versus Placebo in Knee Osteoarthritis
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Knee Osteoarthritis
Keywords: Osteoarthritis
Knee
Hyaluronan
Hyaluronic Acid
Viscoelastic
Hydrogel
Lead sponsor: Fidia Farmaceutici s.p.a.
Sponsor class: INDUSTRY
First posted: 2011-06-14
Enrollment: 800
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain sub-score
timeFrame: 26 weeks
Secondary outcomes:
measure: Responder Analysis
timeFrame: 26 weeks
measure: WOMAC Function
timeFrame: 26 Weeks
measure: Visual Analog Scale (VAS) WOMAC Pain
timeFrame: 26 Weeks
measure: WOMAC Global Score
timeFrame: 26 Weeks
measure: WOMAC Stiffness sub-score
timeFrame: 26 Weeks
measure: Rescue Medication Usage Pill Count, Failure Outcome
timeFrame: 26 Weeks
measure: Patient Global Analysis
timeFrame: 26 Weeks
measure: Clinician Responder Analysis
timeFrame: 26 Weeks
measure: SF Health Outcome
timeFrame: 26 Weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Achieve Clinical Research, LLC
state: Alabama
city: Tucson
country: United States
facility: Tucson Orthopaedic Institute
state: Arizona
city: Encinitas
country: United States
facility: Core Orthopaedic
state: California
city: San Diego
country: United States
facility: San Diego Clinical Trials
state: California
city: Norwalk
country: United States
facility: Norwalk Medical Group
state: Connecticut
city: Stamford
country: United States
facility: Stamford Therapeutics Consortium
state: Connecticut
city: Clearwater
country: United States
facility: Tampa Bay Medical Research
state: Florida
city: Cutler Bay
country: United States
facility: Homestead Clinical Research
state: Florida
city: DeFuniak Springs
country: United States
facility: SJS Clinical Research
state: Florida
city: Deland
country: United States
facility: Avail Clinical Research
state: Florida
city: Edgewater
country: United States
facility: Riverside Clinical Research
state: Florida
city: Gulf Breeze
country: United States
facility: The Andrews Institute
state: Florida
city: New Port Richey
country: United States
facility: Sun Coast Clinical Research
state: Florida
city: Pensacola
country: United States
facility: Pensacola Research Consultants
state: Florida
city: Summerfield
country: United States
facility: Lakeview Medical Research
state: Florida
city: Marietta
country: United States
facility: Drug Studies America
state: Georgia
city: Newnan
country: United States
facility: Better Health Clinical Research
state: Georgia
city: Boise
country: United States
facility: Sonora Clinical Research
state: Idaho
city: Chicago
country: United States
facility: Rush University
state: Illinois
city: Metairie
country: United States
facility: Benchmark Research
state: Louisiana
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: St. Clair Shores
country: United States
facility: Shores Rheumatology
state: Michigan
city: Columbus
country: United States
facility: Columbus Clinical Research
state: Ohio
city: Columbus
country: United States
facility: Radiant Research
state: Ohio
city: Altoona
country: United States
facility: Blair Orthopedics Associates & Sports Medicine
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: State College
country: United States
facility: University Orthopedic Center
state: Pennsylvania
city: Anderson
country: United States
facility: Radiant Research
state: South Carolina
city: Greer
country: United States
facility: Radiant Research
state: South Carolina
city: Austin
country: United States
facility: Tekton Research
state: Texas
city: Tomball
country: United States
facility: Martin Diagnostic Center
state: Texas
city: Spokane
country: United States
facility: Orthopaedic Specialty Clinic
state: Washington
city: San Juan
country: Puerto Rico
facility: Latin Clinical Trial Center
Study officials:
affiliation: Fidia Farmceutici S.p.A.
name: Cynthia Secchieri, PhD
role: STUDY_DIRECTOR
References: