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A Study of Hyaluronate Injectable Viscosupplement for Treatment of Osteoarthritis of the Knee

NCT02495857 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 599

Last updated 2020-06-23

Study results available
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Summary

The study is a prospective, multi-center, randomized, three-arm, parallel group, clinical study to evaluate the superiority of 3 weekly intra-articular (IA) doses of 2 mL of Investigational hyaluronate as compared to placebo injected into the target knee for the treatment of pain in subjects with Osteoarthritis (OA).The safety and effectiveness of the investigational product will also be compared with Euflexxa.

Conditions

Interventions

DEVICE

Hyaluronate Injectable Viscosupplement

Test product of a 1% sodium hyaluronate for injection

DEVICE

Euflexxa IA injection

Brand product of a 1% sodium hyaluronate for injection

DEVICE

Placebo

0.9% sodium chloride, sterile

Sponsors & Collaborators

  • Actavis Inc.

    lead INDUSTRY

Principal Investigators

  • Henry Lay, PhD · Actavis Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-15
Primary Completion
2016-12-05
Completion
2016-12-05

Countries

  • United States

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 NCT02495857 on ClinicalTrials.gov