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Completed

NCT Number: NCT01372475

Hymovis™ Versus Placebo in Knee Osteoarthritis

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Latin Clinical Trial Center, San Juan, Puerto Rico

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Hymovis Intra-articular Injection

Device

Hymovis Intra-articular injection

Other names: HYADD4™, Hyaluronic Acid, HA, Hyaluronate

Phosphate Buffered Saline Injection

Procedure

Placebo Intra-articular injection

Other names: PBS, Saline

Primary outcomes

  1. Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain sub-score

    Time frame: 26 weeks

    WOMAC A Pain sub-score

Secondary outcomes

  1. Responder Analysis

    Time frame: 26 weeks

    Outcome Measures in Rheumatoid Arthritis Clinical Trials - Osteoarthritis Research Society International (OMERACT-OARSI) Criteria

  2. WOMAC Function

    Time frame: 26 Weeks

    WOMAC C Function sub-score

  3. Visual Analog Scale (VAS) WOMAC Pain

    Time frame: 26 Weeks

    Question A1 of WOMAC Pain sub-score

  4. WOMAC Global Score

    Time frame: 26 Weeks

  5. WOMAC Stiffness sub-score

    Time frame: 26 Weeks

    WOMAC C stiffness sub-score

  6. Rescue Medication Usage Pill Count, Failure Outcome

    Time frame: 26 Weeks

  7. Patient Global Analysis

    Time frame: 26 Weeks

  8. Clinician Responder Analysis

    Time frame: 26 Weeks

  9. SF Health Outcome

    Time frame: 26 Weeks

Sponsors and collaborators

Lead sponsor

Fidia Farmaceutici s.p.a.

Industry

Registry information

Official study 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

Acronym: Hymovis

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Jun 14, 2011
Registry last updated
Apr 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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