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Study of Cingal for the Relief of Knee Osteoarthritis Compared to Triamcinolone Hexacetonide at 39 Weeks Follow up

NCT ID: NCT03390036

Last Updated: 2023-05-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

526 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-07

Study Completion Date

2018-07-30

Brief Summary

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

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Detailed Description

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Extension Study to Cingal 16-02: Trial Extension to 39 Week Follow Up in the Randomized, Double-Blind, Active Comparator 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

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

In the 16-02 study, subjects were randomized in a 4:4:1 ratio into the Cingal, Monovisc (hyaluronic acid) or TH (triamcinolone hexacetonide) arm. The 17-02 study is a 39-week follow-up to the 16-02 study.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Study subjects and the Outcomes Assessor are blinded to the study treatment.

Study Groups

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Cingal

Cingal is a combination product consisting of 88 milligrams of crosslinked HA (hyaluronic acid) with 18 milligrams of TH (triamcinolone hexacetonide) in a 4 milliliter (mL) intra-articular injection.

Group Type EXPERIMENTAL

Cingal

Intervention Type COMBINATION_PRODUCT

Hyaluronic Acid with Triamcinolone Hexacetonide

Monovisc

Monovisc is a device that consists of 88 milligrams of cross-linked HA (hyaluronic acid) in a 4 milliliter (mL) intra-articular injection.

Group Type ACTIVE_COMPARATOR

Monovisc

Intervention Type DEVICE

Hyaluronic Acid

Triamcinolone Hexacetonide (TH)

Triamcinolone hexacetonide (TH) is a corticosteroid supplied in a 20 milligram per 1 milliliter (20 mg/mL) intra-articular injection.

Group Type ACTIVE_COMPARATOR

Triamcinolone Hexacetonide

Intervention Type DRUG

Triamcinolone Hexacetonide

Interventions

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Cingal

Hyaluronic Acid with Triamcinolone Hexacetonide

Intervention Type COMBINATION_PRODUCT

Monovisc

Hyaluronic Acid

Intervention Type DEVICE

Triamcinolone Hexacetonide

Triamcinolone Hexacetonide

Intervention Type DRUG

Other Intervention Names

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HA + TH HA TH

Eligibility Criteria

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Inclusion Criteria

2. Subject is able to understand and comply with the requirements of Cingal 17-02 and voluntarily provides consent.
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anika Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laszlo Hangody, MD

Role: PRINCIPAL_INVESTIGATOR

Uzsoki Hospital, Department of Traumatology

Locations

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Health Center of Downtown-Lipotvaros, Orthopedic Outpatient Clinic (Belvárosi-Lipótvárosi Egészségügyi Szolgálat Ortopeadia)

Budapest, , Hungary

Site Status

Uzsoki Hospital, Department of Traumatology

Budapest, , Hungary

Site Status

Jutrix Medical Llc

Budapest, , Hungary

Site Status

Magyar Honvedseg, Egeszseugyi Kozpont, Balesteti Sebeszeti Osztaly

Budapest, , Hungary

Site Status

DE KK Ortopediai Klinika

Debrecen, , Hungary

Site Status

Medidea Bt.

Kiskunfélegyháza, , Hungary

Site Status

Kastelypark Klinka

Tata, , Hungary

Site Status

Zdrowie Osteo-Medic

Bialystok, , Poland

Site Status

Szpital Świętego Łukasza S.A.

Bielsko-Biala, , Poland

Site Status

NZOZ Medi SPATX

Gliwice, , Poland

Site Status

Centrum Medyczne 4M Plus

Krakow, , Poland

Site Status

Medical University of Lodz

Lodz, , Poland

Site Status

Lubelskie Centrum Diagnostyczne

Świdnik, , Poland

Site Status

NOVAMED Jackowiak Krajewski Spółka Jawna

Torun, , Poland

Site Status

Centrum Medyczne Amed Warszawa Targówek

Warsaw, , Poland

Site Status

ETG Network, Warsaw

Warsaw, , Poland

Site Status

ETG Network

Warsaw, , Poland

Site Status

Countries

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Hungary Poland

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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Cingal 17-02

Identifier Type: -

Identifier Source: org_study_id

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