Cingal Study for Knee Osteoarthritis

NCT01891396 | Completed Results DMC

• 1 other identifier: Cingal 13-01
• Study Type: interventional
• Target: 368
• Locations: 5 countries
• Sites: 27

Brief Summary

The purpose of this study is to see if a single injection of Cingal into the knee provides safe relief of pain caused by osteoarthritis.

Conditions

Knee Osteoarthritis

Keywords

Knee osteoarthritis; Hyaluronic acid; HA Injection; Steroid Injection; Knee injection

Outcome Measures

Primary Outcomes (2)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline (ITT)

  The change in knee pain from baseline to 12 weeks as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal® group to the Saline group (ITT population). The WOMAC Pain Score is a validated visual analog scale from 0 mm = no pain to 100 mm = highest pain level. A negative number for the difference from baseline indicates reduction in pain. A greater negative difference from baseline means a better outcome.

  12 Weeks

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline (PP)

  The change in knee pain from baseline to 12 weeks as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal® group to the Saline group (PP population). The WOMAC Pain Score is a validated visual analog scale from 0 mm = no pain to 100 mm = highest pain level. A negative number for the difference from baseline indicates reduction in pain. A greater negative difference from baseline means a better outcome.

  12 Weeks

Secondary Outcomes (24)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Monovisc® (ITT)

  1 Week

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Monovisc® (ITT)

  3 Weeks

• OMERACT-OARSI Responder Index Comparing Cingal® to Saline (ITT)

  12 Weeks

• Patient Global Assessment (PGA) Comparing Cingal® to Saline (ITT)

  12 Weeks

• Patient Global Assessment (PGA) Comparing Cingal® to Monovisc® (ITT)

  1 Week

Study Arms (3)

Saline

PLACEBO COMPARATOR

Single injection of 0.9% saline supplied as a 4 milliliter (mL) unit dose in a 5mL glass syringe

Device: Saline

Hyaluronic Acid and TH (Cingal®)

EXPERIMENTAL

Single injection of sodium hyaluronate with triamcinolone hexacetonide (TH) supplied as a 4 milliliter (mL) unit dose in a 5 mL glass syringe

Device: Hyaluronic Acid and TH (Cingal®)

Hyaluronic Acid (Monovisc®)

ACTIVE COMPARATOR

Single injection of sodium hyaluronate supplied as a 4 milliliter (mL) unit dose in a 5 mL glass syringe

Device: Hyaluronic Acid (Monovisc®)

Interventions

Hyaluronic Acid and TH (Cingal®) DEVICE

Injection into knee

Also known as: Cingal®

Hyaluronic Acid and TH (Cingal®)

Hyaluronic Acid (Monovisc®) DEVICE

Injection into knee

Also known as: Monovisc®

Hyaluronic Acid (Monovisc®)

Saline DEVICE

Saline placebo packaged to look identical to comparator syringes. Injection into knee.

Saline

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is 40 - 75 years old with a Body Mass Index (BMI)≤ 40 kg/m2
• Subject has Kellgren-Lawrence (K-L) severity grade I, II, or III in the index knee as determined by X-Ray. Contralateral knee: K-L severity grade 0, I, or II.

You may not qualify if:

• Subject received an intra-articular (IA) injection of Hyaluronic Acid (HA) and/or steroid in either knee within 6 months of signing the informed consent form (ICF).
• Subject had an arthroscopy of either knee within 3 months of signing the informed consent form (ICF).

Sponsors & Collaborators

• Anika Therapeutics, Inc.: lead

Study Sites (27)

Orthopaedics Clinic Multiprofile Hospital for Active Treatment "Sveti Georgi"

Plovdiv, Bulgaria

Location

Clinic of Orthopaedics and Traumatology, University Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna"

Sofia, Bulgaria

Location

Consultative Outpatients' Medical Office for Rheumatologic Diseases

Sofia, Bulgaria

Location

Department of Orthopaedics and Traumatology Multiprofile Hospital for Active Treatment Lyulin Hospital

Sofia, Bulgaria

Location

Department of Orthopaedics Traumatology - Tokuda Hospital Sofia

Sofia, Bulgaria

Location

Red Deer Regional Hospital Center

Red Deer, Alberta, Canada

Location

Deakon Medicine Professional Corporation

Oakville, Ontario, L6K 3T7, Canada

Location

Sports Medicine Specialists

Toronto, Ontario, Canada

Location

QEII Health Sciences

Halifax, Canada

Location

Revmacentrum MUDr. Moster, s.r.o.

Brno, Czechia

Location

Faculty Hospital Plzen

Pilsen, Czechia

Location

Institute of Rheumatology

Prague, Czechia

Location

Thomayer Hospital Rheumatology Department

Prague, Czechia

Location

Medical Plus s.r.o.

Uherské Hradiště, Czechia

Location

Health Center of Downtown-Lipotvaros, Orthopedic Outpatient Clinic

Budapest, Hungary

Location

Semmelweis Egyetem Orthopaedic Clinic

Budapest, Hungary

Location

Uzsoki Hospital, Department of Traumatology

Budapest, Hungary

Location

Petz Aladar County Teachin Hospital, Traumatology, Orthopaedics and Hand Surgery Centre

Győr, Hungary

Location

Jutrix Medical LLC

Kecskemét, Hungary

Location

Medidea Bt.

Kiskunfélegyháza, Hungary

Location

G&V Pharma-Med Bt.

Makó, Hungary

Location

Osteo-Medic s.c.

Bialystok, Poland

Location

NZOZ Medi SPATX

Gliwice, Poland

Location

ARTIMED Niepubliczny Zakład Opieki Zdrowotnej

Kielce, Poland

Location

CenterMed Krakow Sp. x. o.o.

Krakow, Poland

Location

Radlinski Regional Centre of Orthopeadics and Rehabilitation of Locomotor Organs

Lodz, Poland

Location

Wojewódzki Zespół Reumatologiczny im. Dr Jadwigi Titz-Kosko

Sopot, Poland

Location

Related Publications (1)

• Hangody L, Szody R, Lukasik P, Zgadzaj W, Lenart E, Dokoupilova E, Bichovsk D, Berta A, Vasarhelyi G, Ficzere A, Hangody G, Stevens G, Szendroi M. Intraarticular Injection of a Cross-Linked Sodium Hyaluronate Combined with Triamcinolone Hexacetonide (Cingal) to Provide Symptomatic Relief of Osteoarthritis of the Knee: A Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Trial. Cartilage. 2018 Jul;9(3):276-283. doi: 10.1177/1947603517703732. Epub 2017 May 23.

  PMID: 28535076 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Carol Pekar, VP Clinical Affairs
• Organization: Anika Therapeutics, Inc.

cpekar@anikatherapeutics.com

781.457.9218

Study Officials

• Laszlo Hangody, MD

  Uzsoki Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and Outcomes Assessor were blinded to treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2013
• First Posted: July 3, 2013
• Study Start: June 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: September 1, 2014
• Last Updated: June 1, 2023
• Results First Posted: May 12, 2022

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4); CZ (5); HU (7); BU (5); PL (6)