Hymovis™ Versus Placebo in Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01372475
• Other study ID #: R29-09-02
• Status: Completed
• Phase: Phase 3
• First received: June 10, 2011
• Last updated: March 11, 2014
• Start date: March 2011
• Est. completion date: February 2013

Study information

• Verified date: March 2014
• Source: Fidia Farmaceutici s.p.a.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: February 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Hymovis Intra-articular Injection
Hymovis Intra-articular injection

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Fidia Farmaceutici s.p.a.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain sub-score	WOMAC A Pain sub-score	26 weeks	No
Secondary	Responder Analysis	Outcome Measures in Rheumatoid Arthritis Clinical Trials - Osteoarthritis Research Society International (OMERACT-OARSI) Criteria	26 weeks	No
Secondary	WOMAC Function	WOMAC C Function sub-score	26 Weeks	No
Secondary	Visual Analog Scale (VAS) WOMAC Pain	Question A1 of WOMAC Pain sub-score	26 Weeks	No
Secondary	WOMAC Global Score		26 Weeks	No
Secondary	WOMAC Stiffness sub-score	WOMAC C stiffness sub-score	26 Weeks	No
Secondary	Rescue Medication Usage Pill Count, Failure Outcome		26 Weeks	No
Secondary	Patient Global Analysis		26 Weeks	No
Secondary	Clinician Responder Analysis		26 Weeks	No
Secondary	SF Health Outcome		26 Weeks	No