Cingal Study for Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01891396
• Other study ID #: Cingal 13-01
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: September 2014

Study information

• Verified date: May 2023
• Source: Anika Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study compared three groups of subjects. Group One received a single injection of Cingal (Hyaluronic Acid plus Triamcinolone Hexacetonide). Group Two received a single injection of Monovisc (Hyaluronic Acid). Group Three received a single injection of saline as a placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 368
• Est. completion date: September 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Hyaluronic Acid and TH (Cingal®)
Injection into knee
• Hyaluronic Acid (Monovisc®)
Injection into knee
• Saline
Saline placebo packaged to look identical to comparator syringes. Injection into knee.

Locations

Country	Name	City	State
Bulgaria	Orthopaedics Clinic Multiprofile Hospital for Active Treatment "Sveti Georgi"	Plovdiv
Bulgaria	Clinic of Orthopaedics and Traumatology, University Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna"	Sofia
Bulgaria	Consultative Outpatients' Medical Office for Rheumatologic Diseases	Sofia
Bulgaria	Department of Orthopaedics and Traumatology Multiprofile Hospital for Active Treatment Lyulin Hospital	Sofia
Bulgaria	Department of Orthopaedics Traumatology - Tokuda Hospital Sofia	Sofia
Canada	QEII Health Sciences	Halifax
Canada	Deakon Medicine Professional Corporation	Oakville	Ontario
Canada	Red Deer Regional Hospital Center	Red Deer	Alberta
Canada	Sports Medicine Specialists	Toronto	Ontario
Czechia	Revmacentrum MUDr. Moster, s.r.o.	Brno
Czechia	Faculty Hospital Plzen	Plzen
Czechia	Institute of Rheumatology	Prague
Czechia	Thomayer Hospital Rheumatology Department	Prague
Czechia	Medical Plus s.r.o.	Uherske Hradiste
Hungary	Health Center of Downtown-Lipotvaros, Orthopedic Outpatient Clinic	Budapest
Hungary	Semmelweis Egyetem Orthopaedic Clinic	Budapest
Hungary	Uzsoki Hospital, Department of Traumatology	Budapest
Hungary	Petz Aladar County Teachin Hospital, Traumatology, Orthopaedics and Hand Surgery Centre	Gyor
Hungary	Jutrix Medical LLC	Kecskemet
Hungary	Medidea Bt.	Kiskunfelegyhaza
Hungary	G&V Pharma-Med Bt.	Mako
Poland	Osteo-Medic s.c.	Bialystok
Poland	NZOZ Medi SPATX	Gliwice
Poland	ARTIMED Niepubliczny Zaklad Opieki Zdrowotnej	Kielce
Poland	CenterMed Krakow Sp. x. o.o.	Krakow
Poland	Radlinski Regional Centre of Orthopeadics and Rehabilitation of Locomotor Organs	Lodz
Poland	Wojewódzki Zespól Reumatologiczny im. Dr Jadwigi Titz-Kosko	Sopot

Sponsors (1)

Lead Sponsor	Collaborator
Anika Therapeutics, Inc.

Countries where clinical trial is conducted

Bulgaria,  Canada,  Czechia,  Hungary,  Poland, 

References & 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 (Cing — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Monovisc® (ITT)	The change in knee pain from baseline to 1 week post treatment as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal® group to the Monovisc® 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.	1 Week
Secondary	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Monovisc® (ITT)	The change in knee pain from baseline to 3 weeks as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal® group to the Monovisc® 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 change from baseline indicates reduction in pain. A greater negative difference from baseline means a better outcome.	3 Weeks
Secondary	OMERACT-OARSI Responder Index Comparing Cingal® to Saline (ITT)	The post treatment Responder Rate at 12 weeks is determined through a calculation defined by the Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index. The OMERACT-OARSI Responder Index reports the percentage of subjects that met the criteria to be a good responder. The criteria for response are (1) improvement in pain or physical function =50% and an absolute change =20 mm; or (2) improvement of =20% with an absolute change =10 mm in at least two of the following three categories: pain, physical function, and patient's global assessment.; A higher percentage of subjects responding indicates a better outcome.	12 Weeks
Secondary	Patient Global Assessment (PGA) Comparing Cingal® to Saline (ITT)	The change from baseline to 12 weeks in the Patient Global Assessment (PGA) comparing the Cingal® and Saline arms (ITT population). The PGA is completed by the subject answering the question "Considering all the ways the osteoarthritis in your STUDY knee affects you, what is your assessment of how much your STUDY knee is bothering you today?" The PGA is scored on a 100mm visual analog scale, where 0 mm = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates an improvement in the patient assessment. A greater negative difference means a better outcome.	12 Weeks
Secondary	Patient Global Assessment (PGA) Comparing Cingal® to Monovisc® (ITT)	The change from baseline to 1 week in the Patient Global Assessment (PGA) comparing the Cingal® and Monovisc® arms (ITT population). The PGA is completed by the subject answering the question "Considering all the ways the osteoarthritis in your STUDY knee affects you, what is your assessment of how much your STUDY knee is bothering you today?" The PGA is scored on a 100mm visual analog scale, where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates an improvement in the patient assessment. A greater negative difference means a better outcome.	1 Week
Secondary	Patient Global Assessment (PGA) Comparing Cingal® to Monovisc® (ITT)	Mean change from baseline to 3 weeks in the Patient Global Assessment (PGA) comparing the Cingal® and Monovisc® arms (ITT population). The PGA is completed by the subject answering the question "Considering all the ways the osteoarthritis in your STUDY knee affects you, what is your assessment of how much your STUDY knee is bothering you today?" The PGA is scored on a 100mm visual analog scale, where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates an improvement in the patient assessment. A greater negative difference means a better outcome.	3 Weeks
Secondary	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline (ITT)	Mean change in knee pain from baseline to 26 weeks as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal® group to the Saline group. The WOMAC Pain Score is a validated 100mm 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.	26 Weeks
Secondary	Evaluator Global Assessment Comparing Cingal® to Saline (ITT)	Mean change from baseline to 12 weeks in the Evaluator Global Assessment comparing the Cingal® and Saline arms (ITT population). The Evaluator Global Assessment is completed by the Outcomes Assessor, and answers the question "Considering all the ways the osteoarthritis in the patient's index knee bothers him/her, what is your assessment of how much the patient's knee is bothering him/her today?" The Evaluator Global Assessment is scored on a visual analog scale where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates improvement in the assessment. A greater negative difference means a better outcome.	12 Weeks
Secondary	Evaluator Global Assessment Comparing Cingal® to Monovisc® (ITT)	Mean change from baseline to 1 week in the Evaluator Global Assessment comparing the Cingal® and Monovisc® arms (ITT population). The Evaluator Global Assessment is completed by the Outcomes Assessor, and answers the question "Considering all the ways the osteoarthritis in the patient's index knee bothers him/her, what is your assessment of how much the patient's knee is bothering him/her today?" The Evaluator Global Assessment is scored on a visual analog scale where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates improvement in the assessment. A greater negative difference means a better outcome.	1 Week
Secondary	Evaluator Global Assessment Comparing Cingal® to Monovisc® (ITT)	Mean change from baseline to 3 weeks in the Evaluator Global Assessment comparing the Cingal® and Monovisc® arms (ITT population). The Evaluator Global Assessment is completed by the Outcomes Assessor, and answers the question "Considering all the ways the osteoarthritis in the patient's index knee bothers him/her, what is your assessment of how much the patient's knee is bothering him/her today?" The Evaluator Global Assessment is scored on a visual analog scale where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates improvement in the assessment. A greater negative difference means a better outcome.	3 Week
Secondary	Patient Global Assessment (PGA) Comparing Cingal® to Saline (ITT)	Mean change from baseline to 26 weeks in the Patient Global Assessment (PGA) comparing the Cingal® and Saline arms (ITT population). The PGA is completed by the subject answering the question "Considering all the ways the osteoarthritis in your STUDY knee affects you, what is your assessment of how much your STUDY knee is bothering you today?" The PGA is scored on a 100mm visual analog scale, where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates an improvement in the patient assessment. A greater negative difference means a better outcome.	26 Weeks
Secondary	Evaluator Global Assessment Comparing Cingal® to Saline (ITT)	Mean change from baseline to 26 weeks in the Evaluator Global Assessment comparing the Cingal® and Saline arms (ITT population). The Evaluator Global Assessment is completed by the Outcomes Assessor, and answers the question "Considering all the ways the osteoarthritis in the patient's index knee bothers him/her, what is your assessment of how much the patient's knee is bothering him/her today?" The Evaluator Global Assessment is scored on a visual analog scale where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates improvement in the assessment. A greater negative difference means a better outcome.	26 Weeks
Secondary	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Monovisc® (PP)	Mean change in knee pain from baseline to 1 week as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal® group to the Monovisc® 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.	1 Week
Secondary	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Monovisc® (PP)	Mean change in knee pain from baseline to 3 weeks as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal® group to the Monovisc® 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.	3 Weeks
Secondary	OMERACT-OARSI Responder Index Comparing Cingal® to Saline (PP)	The post treatment Responder Rate comparing Cingal® and Saline at 12 weeks is determined through a calculation defined by the Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index (PP population). The OMERACT-OARSI Responder Index reports the percentage of subjects that met the criteria to be a good responder. The criteria for response are (1) improvement in pain or physical function =50% and an absolute change =20 mm; or (2) improvement of =20% with an absolute change =10 mm in at least two of the following three categories: pain, physical function, and patient's global assessment.; A higher percentage of subjects responding indicates a better outcome.	12 Weeks
Secondary	Patient Global Assessment (PGA) Comparing Cingal® to Saline (PP)	Mean change from baseline to 12 weeks in the Patient Global Assessment (PGA) comparing the Cingal® and Saline arms (PP population). The PGA is completed by the subject answering the question "Considering all the ways the osteoarthritis in your STUDY knee affects you, what is your assessment of how much your STUDY knee is bothering you today?" The PGA is scored on a 100mm visual analog scale, where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates an improvement in the patient assessment. A greater negative difference means a better outcome.	12 Weeks
Secondary	Patient Global Assessment (PGA) Comparing Cingal® to Monovisc® (PP)	The post treatment Responder Rate comparing Cingal® and Monovisc® at 1 week is determined through a calculation defined by the Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index (PP population). The OMERACT-OARSI Responder Index reports the percentage of subjects that met the criteria to be a good responder. A higher percentage of subjects responding indicates a better outcome.	1 Week
Secondary	Patient Global Assessment (PGA) Comparing Cingal® to Monovisc® (PP)	Mean change from baseline to 3 weeks in the Patient Global Assessment (PGA) comparing the Cingal® and Monovisc® arms (PP population). The PGA is completed by the subject answering the question "Considering all the ways the osteoarthritis in your STUDY knee affects you, what is your assessment of how much your STUDY knee is bothering you today?" The PGA is scored on a 100mm visual analog scale, where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates an improvement in the patient assessment. A greater negative difference means a better outcome.	3 Weeks
Secondary	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score Comparing Cingal® to Saline. (PP)	Mean change in knee pain from baseline to 26 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 100mm 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.	26 Weeks
Secondary	Evaluator Global Assessment Comparing Cingal® to Saline (PP)	Mean change from baseline to 12 weeks in the Evaluator Global Assessment comparing the Cingal® and Saline arms (PP population). The Evaluator Global Assessment is completed by the Outcomes Assessor, and answers the question "Considering all the ways the osteoarthritis in the patient's index knee bothers him/her, what is your assessment of how much the patient's knee is bothering him/her today?" The Evaluator Global Assessment is scored on a visual analog scale where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates improvement in the assessment. A greater negative difference means a better outcome.	12 Weeks
Secondary	Evaluator Global Assessment Comparing Cingal® and Monovisc® (PP).	Mean change from baseline to 1 week in the Evaluator Global Assessment comparing the Cingal® and Monovisc® arms (PP population). The Evaluator Global Assessment is completed by the Outcomes Assessor, and answers the question "Considering all the ways the osteoarthritis in the patient's index knee bothers him/her, what is your assessment of how much the patient's knee is bothering him/her today?" The Evaluator Global Assessment is scored on a visual analog scale where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates improvement in the assessment. A greater negative difference means a better outcome.	1 Week
Secondary	Evaluator Global Assessment Comparing Cingal® to Monovisc® (PP)	Mean change from baseline to 3 weeks in the Evaluator Global Assessment comparing the Cingal® and Monovisc® arms (PP population). The Evaluator Global Assessment is completed by the Outcomes Assessor, and answers the question "Considering all the ways the osteoarthritis in the patient's index knee bothers him/her, what is your assessment of how much the patient's knee is bothering him/her today?" The Evaluator Global Assessment is scored on a visual analog scale where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates improvement in the assessment. A greater negative difference means a better outcome.	3 Week
Secondary	Patient Global Assessment (PGA) Comparing Cingal® to Saline (PP)	Mean change from baseline to 26 weeks in the Patient Global Assessment (PGA) comparing the Cingal® and Saline arms (PP population). The PGA is completed by the subject answering the question "Considering all the ways the osteoarthritis in your STUDY knee affects you, what is your assessment of how much your STUDY knee is bothering you today?" The PGA is scored on a 100mm visual analog scale, where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates an improvement in the patient assessment. A greater negative difference means a better outcome.	26 Weeks
Secondary	Evaluator Global Assessment Comparing Cingal® to Saline (PP)	Mean change from baseline to 26 weeks in the Evaluator Global Assessment comparing the Cingal® and Saline arms (PP population). The Evaluator Global Assessment is completed by the Outcomes Assessor, and answers the question "Considering all the ways the osteoarthritis in the patient's index knee bothers him/her, what is your assessment of how much the patient's knee is bothering him/her today?" The Evaluator Global Assessment is scored on a visual analog scale where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the difference from baseline indicates improvement in the assessment. A greater negative difference means a better outcome.	26 Weeks