CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 526 enrolled
Drug / intervention
Cingal +2 morecombination
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/NCT03390036
NCT03390036Phase 3Completed
CompareCT.gov

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

Anika Therapeutics, Inc.·interventional·Posted Jan 4, 2018·Updated May 31, 2023

In Brief

A Phase 3 clinical trial evaluating Cingal, Monovisc, and 1 other intervention for Knee Osteoarthritis. Completed, enrolled 526 participants across 17 sites in 2 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKnee Osteoarthritis
CountriesHungary, Poland
Collaborators--

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJan 4, 2018
Enrollment StartDec 7, 2017
Primary CompletionJul 30, 2018
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 8.5 years ago

Interventions

Cingalcombination

Hyaluronic Acid with Triamcinolone Hexacetonide

Monoviscdevice

Hyaluronic Acid

Triamcinolone Hexacetonidedrug

Triamcinolone Hexacetonide