NCT01891396

Cingal Study for Knee Osteoarthritis

A Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of a Single Injection Cross-Linked Sodium Hyaluronate Combined With Triamcinolone Hexacetonide (Cingal) to Provide Symptomatic Relief of Osteoarthritis of the Knee

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 368 (actual)
• Sponsor: Anika Therapeutics, Inc. · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see if a single injection of Cingal into the knee provides safe relief of pain caused by osteoarthritis.

Detailed description

This study compared three groups of subjects. Group One received a single injection of Cingal (Hyaluronic Acid plus Triamcinolone Hexacetonide). Group Two received a single injection of Monovisc (Hyaluronic Acid). Group Three received a single injection of saline as a placebo.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Hyaluronic Acid and TH (Cingal®)	Injection into knee
DEVICE	Hyaluronic Acid (Monovisc®)	Injection into knee
DEVICE	Saline	Saline placebo packaged to look identical to comparator syringes. Injection into knee.

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-05-01
• Completion: 2014-09-01
• First posted: 2013-07-03
• Last updated: 2023-06-01
• Results posted: 2022-05-12

Locations

27 sites across 5 countries: Bulgaria, Canada, Czechia, Hungary, Poland