Safety and Effectiveness Study of a Non-Crosslinked HA Alkylamide HYADD(TM) 4 Hydrogel for Osteoarthritis of the Knee

NCT ID: NCT02187549

Last Updated: 2015-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

332 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine whether intra-articular hyaluronic acid provides symptomatic relief of osteoarthritis of the knee.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Osteoarthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HYMOVIS

HYADD(TM) 4 Hydrogel Intra-Articular Injection

Group Type EXPERIMENTAL

HYMOVIS

Intervention Type DEVICE

Intra-articular injection

Placebo

Saline Intra-Articular Injection

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DEVICE

Intra-Articular Injection

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HYMOVIS

Intra-articular injection

Intervention Type DEVICE

Placebo

Intra-Articular Injection

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

HYADD(TM) 4 Hydrogel Intra-Articular Injection Placebo Intra-Articular Injection

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Symptomatic osteoarthritis of the knee.

Exclusion Criteria

* No disorders which could interfere with study required assessments.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fidia Farmaceutici s.p.a.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Achieve Clinical Research

Birmingham, Alabama, United States

Site Status

Alabama Clinical Therapeutics

Brimingham, Alabama, United States

Site Status

Elite Clinical Studies

Phoenix, Arizona, United States

Site Status

Arizona Research Center

Phoenix, Arizona, United States

Site Status

Med Center

Carmichael, California, United States

Site Status

Triwest Research Associates

El Cajon, California, United States

Site Status

Westlake Medical

Thousand Oaks, California, United States

Site Status

Colorado Orthopedic Consultants

Englewood, Colorado, United States

Site Status

Chase Medical

Waterbury, Connecticut, United States

Site Status

Riverside Clinical Research

Edgewater, Florida, United States

Site Status

Suncoast Clinical Research

New Port Richey, Florida, United States

Site Status

Ormond Medical Arts

Ormond Beach, Florida, United States

Site Status

Tufts Medical Center

Boston, Massachusetts, United States

Site Status

Great Lakes Research Group

Bay City, Michigan, United States

Site Status

Healthcare Research Network

Hazelwood, Missouri, United States

Site Status

Fabio Orozco

Egg Harbor, New Jersey, United States

Site Status

PMG Research of Raleigh

Raleigh, North Carolina, United States

Site Status

New Horizons

Cincinnati, Ohio, United States

Site Status

Columbus Clinical Research

Columbus, Ohio, United States

Site Status

Blair Orphopedics

Altoona, Pennsylvania, United States

Site Status

West Houston Clinical Research

Houston, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EQE7-13-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.