NCT02495857

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 599 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-08-15
• Primary completion: 2016-12-05
• Completion: 2016-12-05
• First posted: 2015-07-13
• Last updated: 2020-06-23
• Results posted: 2020-06-23

Locations

2 sites across 1 country: United States