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Hymovis™ Versus Placebo in Knee Osteoarthritis

NCT01372475 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2014-04-08

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Hymovis Intra-articular Injection

Hymovis Intra-articular injection

PROCEDURE

Phosphate Buffered Saline Injection

Placebo Intra-articular injection

Sponsors & Collaborators

  • Fidia Farmaceutici s.p.a.

    lead INDUSTRY

Principal Investigators

  • Cynthia Secchieri, PhD · Fidia Farmceutici S.p.A.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-11-30
Completion
2013-02-28

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01372475 on ClinicalTrials.gov