Hymovis™ Versus Placebo in Knee Osteoarthritis

Phase 3

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Device: Hymovis Intra-articular Injection; Procedure: Phosphate Buffered Saline Injection

• Registration Number: NCT01372475
• Lead Sponsor: Fidia Farmaceutici s.p.a.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-06-10
• Study First Submitted QC: 2011-06-13
• Study First Posted: 2011-06-14
• Primary Completion: 2012-11
• Study Completion: 2013-02
• Status Verified: 2014-03
• Disposition First Submitted: 2014-03-11
• Disposition First Submitted QC: 2014-03-11
• Last Update Submitted: 2014-03-11
• Disposition First Posted: 2014-04-08
• Last Update Posted: 2014-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hymovis Viscoelastic Hydrogel	Hymovis Intra-articular Injection	Intra-articular Injection
Placebo	Phosphate Buffered Saline Injection	Phosphate Buffered Saline Intra-articular Injection

Primary Outcome Measures

Name	Time	Method
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain sub-score	26 weeks	WOMAC A Pain sub-score

Secondary Outcome Measures

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

Trial Locations

Locations (31)

San Diego Clinical Trials; 🇺🇸 San Diego, California, United States

Shores Rheumatology; 🇺🇸 St. Clair Shores, Michigan, United States

Lakeview Medical Research; 🇺🇸 Summerfield, Florida, United States

Drug Studies America; 🇺🇸 Marietta, Georgia, United States

Sonora Clinical Research; 🇺🇸 Boise, Idaho, United States

Rush University; 🇺🇸 Chicago, Illinois, United States

Columbus Clinical Research; 🇺🇸 Columbus, Ohio, United States

Latin Clinical Trial Center; 🇵🇷 San Juan, Puerto Rico

Benchmark Research; 🇺🇸 Metairie, Louisiana, United States

Altoona Center for Clinical Research; 🇺🇸 Duncansville, Pennsylvania, United States

UMass Memorial Medical Center; 🇺🇸 Worcester, Massachusetts, United States

University Orthopedic Center; 🇺🇸 State College, Pennsylvania, United States

Sun Coast Clinical Research; 🇺🇸 New Port Richey, Florida, United States

Better Health Clinical Research; 🇺🇸 Newnan, Georgia, United States

Tekton Research; 🇺🇸 Austin, Texas, United States

Achieve Clinical Research, LLC; 🇺🇸 Birmingham, Alabama, United States

Core Orthopaedic; 🇺🇸 Encinitas, California, United States

Stamford Therapeutics Consortium; 🇺🇸 Stamford, Connecticut, United States

Norwalk Medical Group; 🇺🇸 Norwalk, Connecticut, United States

Tampa Bay Medical Research; 🇺🇸 Clearwater, Florida, United States

Tucson Orthopaedic Institute; 🇺🇸 Tucson, Arizona, 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

The Andrews Institute; 🇺🇸 Gulf Breeze, Florida, United States

Pensacola Research Consultants; 🇺🇸 Pensacola, Florida, United States

Blair Orthopedics Associates & Sports Medicine; 🇺🇸 Altoona, Pennsylvania, United States

Orthopaedic Specialty Clinic; 🇺🇸 Spokane, Washington, United States

Riverside Clinical Research; 🇺🇸 Edgewater, Florida, United States

Martin Diagnostic Center; 🇺🇸 Tomball, Texas, United States

Radiant Research; 🇺🇸 Greer, South Carolina, United States