Repeat Injection of Cingal® for Osteoarthritis of the Knee

Status Completed

Clinical Trial Summary

The objective of this study is to evaluate the safety of an injection of Cingal® in subjects with Osteoarthritis (OA) of the knee who participated in Cingal 13-01, and who received either a Cingal, Monovisc, or saline injection in the 13-01 study. The safety evaluation will be done by a through examination of the incidence of adverse events and physical examination of the knee.

Clinical Trial Description

The Cingal 13-02 study is a follow-on study to the recently completed clinical trial Cingal 13-01 [NCT01891396]. Cingal 13-01 was a multi-center, randomized, double-blind, Phase III study that enrolled 368 subjects at up to 20 sites in Canada and Europe. The Cingal 13-01 study objective was to assess the safety and effectiveness of a single injection of Cingal® for relief of joint pain and symptoms in patients with osteoarthritis (OA) of the knee. The study had three arms: the Cingal® investigational arm, an active comparator arm (Monovisc®) and a control arm (saline). Cingal 13-02 is designed to evaluate the safety of an open-label injection of Cingal® in subjects who received a study injection in the Cingal 13-01 trial. Sites that enrolled 5 or more subjects in the Cingal 13-01 study were eligible to participate in the Cingal 13-02 study. All subjects at these sites who met enrollment criteria had the option to participate in the follow-on study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02381652
Study type	Interventional
Source	Anika Therapeutics, Inc.
Contact
Status	Completed
Phase	Phase 3
Start date	February 2015
Completion date	May 2015

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