CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 231 enrolled
Drug / intervention
Cingal +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04231318
NCT04231318Phase 3Completed
CompareCT.gov

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

Anika Therapeutics, Inc.·interventional·Posted Jan 18, 2020·Updated Aug 9, 2023

In Brief

A Phase 3 clinical trial evaluating Cingal, Triamcinolone Hexacetonide (TH), and 1 other intervention for Osteoarthritis, Knee. Completed, enrolled 231 participants across 26 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis, Knee
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedJan 18, 2020
Enrollment StartSep 11, 2020
Primary CompletionMay 16, 2022
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 6.5 years ago

Interventions

Cingaldrug

Single intra-articular injection of Cingal into the knee.

Triamcinolone Hexacetonide (TH)drug

Single intra-articular injection of TH into the knee.

Placebodrug

Single intra-articular injection Placebo (0.9% Saline) into the knee.