Study of Cingal® and Triamcinolone Hexacetonide for the Relief of Knee Osteoarthritis Pain
Summary
This is a multi-center, randomized, double-blind, parallel group, placebo controlled trial to compare the safety and effectiveness of a single injection of Cingal® to a single injection of Triamcinolone Hexacetonide (TH) to achieve pain relief and other symptoms of osteoarthritis of the knee.
Timeline
- Start
- 2020-09-11
- Primary completion
- 2022-05-16
- Completion
- 2022-05-16
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
registry MEAN Cingal: -44.3 (Standard Deviation 21.6) score on a scale reads as mixed primary results NCT04231318 ↗
registry analysis (superiority test); Cingal vs Triamcinolone Hexacetonide (TH); p = 0.0406; ANOVA reads as mixed primary results NCT04231318 ↗
registry analysis (superiority test); CINGAL vs Triamcinolone Hexacetonide (TH); p = 0.1942; ANOVA reads as mixed primary results NCT04231318 ↗
registry analysis (superiority test); CINGAL vs Placebo; p = 0.0957; ANOVA reads as mixed primary results NCT04231318 ↗
registry analysis (superiority test); Cingal vs Placebo; p = 0.0423; ANOVA reads as mixed primary results NCT04231318 ↗
release “Cingal® met its primary endpoint in a Phase III Study (Cingal 19-01), demonstrating superiority over triamcinolone hexacetonide (TH) steroid alone at 26 weeks post-treatment.” reads as met primary endpoint anika.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cingal | Unknown | 4 ml | Other |
| Comparator | Triamcinolone Hexacetonide (TH) | Unknown | 1 ml | Other |