NCT03191903

Study of Cingal™ for the Relief of Knee Osteoarthritis Compared to Triamcinolone Hexacetonide

Randomized, Double-Blind, Active Comparator 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: Phase 3
• Study type: Interventional
• Enrollment: 576 (actual)
• Sponsor: Anika Therapeutics, Inc. · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, randomized, double-blind, parallel group, active comparator controlled trial to evaluate the efficacy and safety of a single injection of Cingal for the relief of joint pain in subjects with OA of the knee.

Detailed description

Cingal 16-02 is a multi-center, randomized, double-blind, active comparator controlled study designed to evaluate the relative contributions of the individual constituents (Hyaluronic Acid and Triamcinolone Hexacetonide) in the Cingal combination product to pain relief as measured by the change in WOMAC Pain from baseline through 26 weeks.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Cingal	Hyaluronic Acid with Triamcinolone Hexacetonide
DEVICE	Monovisc	Hyaluronic acid
DRUG	Triamcinolone Hexacetonide	Triamcinolone Hexacetonide

Timeline

• Start date: 2017-05-25
• Primary completion: 2018-04-23
• Completion: 2018-04-23
• First posted: 2017-06-19
• Last updated: 2022-02-24
• Results posted: 2022-02-24

Locations

19 sites across 2 countries: Hungary, Poland

Regulatory

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