NCT04231318

Study of Cingal® and Triamcinolone Hexacetonide for the Relief of Knee Osteoarthritis Pain

A Randomized, Double-Blind, Placebo 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: 231 (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, 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.

Detailed description

To determine the contribution of Triamcinolone Hexacetonide (TH) when combined with sodium hyaluronate for pain relief, both in terms of magnitude and duration, when used as single injection, as compared to a single injection of TH alone in subjects diagnosed with osteoarthritis of the knee. A saline placebo is included within the trial to set the expectation of a return to Baseline pain for the subjects.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DRUG	Cingal	Single intra-articular injection of Cingal into the knee.
DRUG	Triamcinolone Hexacetonide (TH)	Single intra-articular injection of TH into the knee.
DRUG	Placebo	Single intra-articular injection Placebo (0.9% Saline) into the knee.

Timeline

• Start date: 2020-09-11
• Primary completion: 2022-05-16
• Completion: 2022-05-16
• First posted: 2020-01-18
• Last updated: 2023-08-09
• Results posted: 2023-08-09

Locations

26 sites across 1 country: United States

Regulatory

• FDA-regulated drug study