NCT03390036

Study of Cingal for the Relief of Knee Osteoarthritis Compared to Triamcinolone Hexacetonide at 39 Weeks Follow up

Trial Extension Protocol to Add a 39 Week Follow Up to Cingal 16-02, a Randomized, Double-Blind, Active Comparator Controlled, Multi-Center Study of a Single Injection of Cingal to Provide Symptomatic Relief of Knee Osteoarthritis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 526 (actual)
• Sponsor: Anika Therapeutics, Inc. · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Extension study to Cingal 16-02 to obtain 39-week safety and efficacy follow-up data

Detailed description

Extension Study to Cingal 16-02: Trial Extension to 39 Week Follow Up in the 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

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: 2017-12-07
• Primary completion: 2018-07-30
• Completion: 2018-07-30
• First posted: 2018-01-04
• Last updated: 2023-05-31
• Results posted: 2023-05-31

Locations

17 sites across 2 countries: Hungary, Poland

Regulatory

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