NCT02381652

Repeat Injection of Cingal® for Osteoarthritis of the Knee

An Open-Label, Follow-On Study to Cingal 13-01 to Evaluate the Safety of a Repeat Injection of Cross-Linked Sodium Hyaluronate Combined With Triamcinolone Hexacetonide to Provide Symptomatic Relief of Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 242 (actual)
• Sponsor: Anika Therapeutics, Inc. · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Cingal	Injection into the knee
COMBINATION_PRODUCT	Cingal	Injection into the knee
COMBINATION_PRODUCT	Cingal	Injection into the knee

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-04-01
• Completion: 2015-05-01
• First posted: 2015-03-06
• Last updated: 2022-03-22
• Results posted: 2020-09-03

Locations

10 sites across 3 countries: Czechia, Hungary, Poland

Regulatory

• FDA-regulated drug study
• FDA-regulated device study