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

Osteoarthritis Clinical Trial

Official title:
A Double-Blind, Randomized, Study of the Effectiveness and Safety of Hyaluronate Injectable Viscosupplement for Treatment of Osteoarthritis of the Knee

Clinical Trial 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.

Clinical Trial Description

The primary objective is to evaluate the safety and effectiveness of 3 weekly IA doses of 2 mL of hyaluronate viscosupplement as compared to placebo injected into the target knee for the treatment of pain in subjects with OA As secondary objectives, the study will evaluate the safety and effectiveness of 3 weekly IA doses of 2 mL of Viscosupplement as compared to Euflexxa injected into the target knee for the treatment of pain in subjects with OA. In addition, to assess the effect of Viscosupplement on pain, stiffness, and physical function of the target knee, as well as functional health and general well-being ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02495857
Study type Interventional
Source Actavis Inc.
Contact
Status Completed
Phase N/A
Start date August 15, 2015
Completion date December 5, 2016
View Details
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