Clinical trial NCT03390036: Study of Cingal for the Relief of Knee Osteoarthritis Compared to Triamcinolone Hexacetonide at 39 Weeks Follow up
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Knee Osteoarthritis
Keywords: Osteoarthritis
Intra-articular Injection
Hyaluronic Acid
Triamcinolone Hexacetonide
Lead sponsor: Anika Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-01-04
Enrollment: 526
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

1. Only subjects that were enrolled and met the inclusion criteria for the Cingal 16-02 trial and signed the informed consent are eligible for Cingal 17-02 trial.
2. Subject is able to understand and comply with the requirements of Cingal 17-02 and voluntarily provides consent.

Exclusion Criteria:

Patients will not be rescreened at enrollment to Cingal 17-02 as these patients met the inclusion / exclusion criteria for the Cingal 16-02 clinical trial.

Primary outcomes:
measure: OMERACT-OARSI Responder Rate at 39 Weeks
timeFrame: 39 weeks
Secondary outcomes:
measure: Change From Baseline in WOMAC Pain Score at 39 Weeks
timeFrame: 39 Weeks
measure: Change From Baseline in WOMAC Physical Function Score at 39 Weeks
timeFrame: 39 Weeks
measure: Change From Baseline in WOMAC Stiffness Score at 39 Weeks
timeFrame: 39 Weeks
measure: Change From Baseline in Total WOMAC Score at 39 Weeks
timeFrame: 39 Weeks
measure: Change From Baseline in Patient Global Assessment at 39 Weeks
timeFrame: 39 Weeks
measure: Change From Baseline in Evaluator Global Assessment at 39 Weeks
timeFrame: 39 Weeks
measure: The Usage of Rescue Medication (Acetaminophen) at Week 39
timeFrame: 39 Weeks
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Health Center of Downtown-Lipotvaros, Orthopedic Outpatient Clinic (Belvárosi-Lipótvárosi Egészségügyi Szolgálat Ortopeadia)
city: Budapest
country: Hungary
facility: Uzsoki Hospital, Department of Traumatology
city: Budapest
country: Hungary
facility: Jutrix Medical Llc
city: Budapest
country: Hungary
facility: Magyar Honvedseg, Egeszseugyi Kozpont, Balesteti Sebeszeti Osztaly
city: Debrecen
country: Hungary
facility: DE KK Ortopediai Klinika
city: Kiskunfelegyhaza
country: Hungary
facility: Medidea Bt.
city: Tata
country: Hungary
facility: Kastelypark Klinka
city: Białystok
country: Poland
facility: Zdrowie Osteo-Medic
city: Bielsko-Biała
country: Poland
facility: Szpital Świętego Łukasza S.A.
city: GLIwice
country: Poland
facility: NZOZ Medi SPATX
city: Kraków
country: Poland
facility: Centrum Medyczne 4M Plus
city: Toruń
country: Poland
facility: NOVAMED Jackowiak Krajewski Spółka Jawna
city: Warsaw
country: Poland
facility: Centrum Medyczne Amed Warszawa Targówek
city: Warsaw
country: Poland
facility: ETG Network, Warsaw
city: Warsaw
country: Poland
facility: ETG Network
city: Łódź
country: Poland
facility: Medical University of Lodz
city: Świdnik,
country: Poland
facility: Lubelskie Centrum Diagnostyczne
Study officials:
affiliation: Uzsoki Hospital, Department of Traumatology
name: Laszlo Hangody, MD
role: PRINCIPAL_INVESTIGATOR
References: