drugset / Trial / NCT03191903

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

NCT03191903 ↗

Phase 3 Completed 576 enrolled Anika Therapeutics, Inc.
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2017-05-25
Primary completion
2018-04-23
Completion
2018-04-23

Outcome

Missed primary endpoint

registry analysis (superiority test); Cingal vs Triamcinolone Hexacetonide (TH); p = 0.5874; ANOVA NCT03191903 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Hyaluronic Acid Other / unclassified 88 mg Other
Comparator Triamcinolone Hexacetonide Other / unclassified 18 mg Other
Comparator Triamcinolone Hexacetonide Other / unclassified 20 mg Other

Indications