Hymovis™ Versus Placebo in Knee Osteoarthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fidia Farmaceutici s.p.a.
ClinicalTrials.gov Identifier:
NCT01372475
First received: June 10, 2011
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Knee Osteoarthritis
Device: Hymovis Intra-articular Injection
Procedure: Phosphate Buffered Saline Injection
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Fidia Farmaceutici s.p.a.:

Primary Outcome Measures:
  • Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain sub-score [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    WOMAC A Pain sub-score


Secondary Outcome Measures:
  • Responder Analysis [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    Outcome Measures in Rheumatoid Arthritis Clinical Trials - Osteoarthritis Research Society International (OMERACT-OARSI) Criteria

  • WOMAC Function [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
    WOMAC C Function sub-score

  • Visual Analog Scale (VAS) WOMAC Pain [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
    Question A1 of WOMAC Pain sub-score

  • WOMAC Global Score [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
  • WOMAC Stiffness sub-score [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
    WOMAC C stiffness sub-score

  • Rescue Medication Usage Pill Count, Failure Outcome [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
  • Patient Global Analysis [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
  • Clinician Responder Analysis [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
  • SF Health Outcome [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]

Enrollment: 800
Study Start Date: March 2011
Study Completion Date: February 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Hymovis Viscoelastic Hydrogel
Intra-articular Injection
Device: Hymovis Intra-articular Injection
Hymovis Intra-articular injection
Other Names:
  • HYADD4™
  • Hyaluronic Acid
  • HA
  • Hyaluronate
Placebo Comparator: Placebo
Phosphate Buffered Saline Intra-articular Injection
Procedure: Phosphate Buffered Saline Injection
Placebo Intra-articular injection
Other Names:
  • PBS
  • Saline

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01372475

  Show 33 Study Locations
Sponsors and Collaborators
Fidia Farmaceutici s.p.a.
Investigators
Study Director: Cynthia Secchieri, PhD Fidia Farmceutici S.p.A.
  More Information

No publications provided

Responsible Party: Fidia Farmaceutici s.p.a.
ClinicalTrials.gov Identifier: NCT01372475     History of Changes
Other Study ID Numbers: R29-09-02
Study First Received: June 10, 2011
Last Updated: March 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Fidia Farmaceutici s.p.a.:
Osteoarthritis
Knee
Hyaluronan
Hyaluronic Acid
Viscoelastic
Hydrogel

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014