Efficacy and Safety of Intraarticular Sodium Hyaluronate Single Injection in Patients With Osteoarthritis of the Knee
Primary Purpose
Osteoarthritis, Knee
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Sodium hyaluronate 2%
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
Eligibility Criteria
Inclusion Criteria:
- Patient ≥ 45 years of age of either sex.
- Primary knee OA of the medial or lateral femoro-tibial compartment documented according to ACR criteria with symptoms, at screening, from at least 3 months.
- KL radiological grade 2-3.
- Antero-posterior view X-Ray image of the target knee
- Pain intensity at screening in the target knee ≥40 mm and <80 mm measured by Visual Analogue Scale (VAS), and ≤ 20 mm in the contralateral knee.
- Able to understand and willing to comply with study procedures.
- Able to provide informed consent.
Exclusion Criteria:
- BMI ≥ 30 kg/m2.
- Pregnant or lactating women. Women of child-bearing age not using effective contraception.
- Severe inflammation of the target knee.
- Previous surgery in the target knee, including arthroscopy.
- Subjects with any musculoskeletal condition affecting the target knee that would impair the proper evaluation
- Patients with joint inflammatory disease, microcrystalline arthropathies and significant osteoarthritis symptoms in other joints apart from the knee, and which require pharmacological treatment.
- Underlying disease considered by the investigator that might interfere with the development and evaluation study.
- Subjects with venous or lymphatic stasis in the relevant limb.
- Previous administration of any of the following treatments: hyaluronic acid i.a. (last year); steroids i.a. or joint lavage (last 3 months), glucosamine sulfate, chondroitin sulfate or diacerein (last 3 months), NSAIDs (last 14 days), any investigational drug (last month) or its administration during this study.
- Pain in other parts of the body greater than the knee pain that could interfere with the evaluation.
- Any pathology that, under investigator judgement, interfere with the administration or assessment.
- Patients with known hypersensitivity to SH or paracetamol.
- Patients in waiting list for surgery.
- Patients awaiting disablement assessment.
- Previous participation in this protocol
Sites / Locations
- Hospital General de ElcheRecruiting
- Hospital de la Marina Baixa de VillajoyosaRecruiting
- Hospital Universitario Fundación AlcorcónRecruiting
- Hospital Universitario Reina SofiaRecruiting
- Complejo Hospitalario La CoruñaRecruiting
- Clinica Universitaria de NavarraRecruiting
- Hospital Clínico San CarlosRecruiting
- Hospital Universitario Fundación Jiménez DíazRecruiting
- Hospital Universitario 12 de OctubreRecruiting
- Hospital Universitario La PazRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental: Sodium Hyaluronate 2%
Arm Description
Each patient will receive a single injection of SH2%
Outcomes
Primary Outcome Measures
Change in pain intensity according to VAS (0-100mm)
The VAS to be used in the study consists of a horizontal line marked from 0 to 100 mm, where 0 means no pain and 100 is the greatest possible pain. Patients must draw a vertical line at the point that they believe that represents the pain intensity at that time.
Secondary Outcome Measures
Change in function from baseline in the target knee
Physical function will be measured by using the function subscale of the Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC). This index contains 24 items on different activities of daily life grouped in three subscales: pain (5 items), stiffness (2 items), and functional capacity (17 items). For each item a horizontal visual analogue scale of 0 to 100 mm with end descriptors is used, whose path goes from no pain, no stiffness, no difficulty to extreme pain, extreme stiffness, extreme difficulty.
Change in function from baseline in the target knee
Physical function will be measured by using the function subscale of the Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC). This subscale contains 24 items on different activities of daily life grouped in three dimensions: pain, stiffness, and functional capacity. For each item a horizontal visual analogue scale of 0 to 100 mm with end descriptors is used, whose path goes from no pain, no stiffness, no difficulty to extreme pain, extreme stiffness, extreme difficulty function subscale
Percentage of patients achieving the Minimally Clinical Important Improvement (MCII)
The MCII is the smallest change in measurement that signifies an important improvement in a patient's symptom
Percentage of patients achieving the Patient Acceptable Symptoms State (PASS)
Defined as the value beyond which patients consider themselves well. According to the literature the recommended value for PASS (measured on 0-100 VAS) is < 40.
Patient and investigator global assessments
Both will be measured using a 5-point Likert scale. This is a five-level classification scale (0= Better, 1 = best, 2 = same, 3 = worst, 4 = much worse)
Full Information
NCT ID
NCT03852914
First Posted
February 22, 2019
Last Updated
February 27, 2019
Sponsor
Tedec-Meiji Farma, S.A.
Collaborators
Alpha Bioresearch S.L.
1. Study Identification
Unique Protocol Identification Number
NCT03852914
Brief Title
Efficacy and Safety of Intraarticular Sodium Hyaluronate Single Injection in Patients With Osteoarthritis of the Knee
Official Title
Prospective, Multicentre Study to Evaluate the Efficacy and Safety of Intraarticular Sodium Hyaluronate Single Injection in Patients Suffering From Osteoarthritis of the Knee
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 17, 2019 (Actual)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
April 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tedec-Meiji Farma, S.A.
Collaborators
Alpha Bioresearch S.L.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A Phase III, prospective, multicentre, non-controlled, with consecutive participant enrollment in order to evaluate the efficacy, safety and duration of the effects of the viscosupplementation with a preparation of sodium hyaluronate 2% (SH2%) from Tedec-Meiji Farma S.A. over 12 months. Adult patients diagnosed with primary osteoarthritis of the knee according to American College of Rheumatology (ACR) criteria with radiological grades II and III according to Kellgren-Lawrence scale (KL) will receive a single injection of SH2% and will be followed for 1 year with follow up visits at 6 and 12 months.
At 6 months patients could be offered a second injection whenever and when they comply with the criteria established for re-treatment and will be followed for additional 6 months
Detailed Description
Prospective, multicentre and non-controlled study. Each patient will receive a single injection of SH 2% and will be followed for 1 year with follow up visits at 6 and 12 months At 6 months follow up visit patients will be offered a second injection whenever and when they comply with the criteria established for re-treatment and will be followed for additional 6 months From the pre-inclusion V0 up to the V1 (beginning of treatment), there will be a wash-out period of 2 weeks during which only paracetamol will be allowed for osteoarthritis (OA) pain relief (maximum dose allowed:3g/day).
Paracetamol will be discontinued at least 24h before follow up visits (Treatment administration, 6 months of follow up and 12 months of follow up).
Clinical evaluation will be done every visits through VAS, WOMAC and Patient's Global Assessment/ Investigator's Global Assessment (PGA/IGA)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
93 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental: Sodium Hyaluronate 2%
Arm Type
Experimental
Arm Description
Each patient will receive a single injection of SH2%
Intervention Type
Device
Intervention Name(s)
Sodium hyaluronate 2%
Intervention Description
Each patient will receive a single injection of SH 2% and will be followed for 6 months. At 6 months follow up visit patients could be offered a second injection whenever and when they comply with the criteria established for re-treatment and will be followed for additional 6 months.
Primary Outcome Measure Information:
Title
Change in pain intensity according to VAS (0-100mm)
Description
The VAS to be used in the study consists of a horizontal line marked from 0 to 100 mm, where 0 means no pain and 100 is the greatest possible pain. Patients must draw a vertical line at the point that they believe that represents the pain intensity at that time.
Time Frame
6 and 12 months after treatment
Secondary Outcome Measure Information:
Title
Change in function from baseline in the target knee
Description
Physical function will be measured by using the function subscale of the Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC). This index contains 24 items on different activities of daily life grouped in three subscales: pain (5 items), stiffness (2 items), and functional capacity (17 items). For each item a horizontal visual analogue scale of 0 to 100 mm with end descriptors is used, whose path goes from no pain, no stiffness, no difficulty to extreme pain, extreme stiffness, extreme difficulty.
Time Frame
6 and 12 months after treatment
Title
Change in function from baseline in the target knee
Description
Physical function will be measured by using the function subscale of the Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC). This subscale contains 24 items on different activities of daily life grouped in three dimensions: pain, stiffness, and functional capacity. For each item a horizontal visual analogue scale of 0 to 100 mm with end descriptors is used, whose path goes from no pain, no stiffness, no difficulty to extreme pain, extreme stiffness, extreme difficulty function subscale
Time Frame
6 and 12 months after treatment
Title
Percentage of patients achieving the Minimally Clinical Important Improvement (MCII)
Description
The MCII is the smallest change in measurement that signifies an important improvement in a patient's symptom
Time Frame
6 and 12 months after treatment
Title
Percentage of patients achieving the Patient Acceptable Symptoms State (PASS)
Description
Defined as the value beyond which patients consider themselves well. According to the literature the recommended value for PASS (measured on 0-100 VAS) is < 40.
Time Frame
6 and 12 months after treatment
Title
Patient and investigator global assessments
Description
Both will be measured using a 5-point Likert scale. This is a five-level classification scale (0= Better, 1 = best, 2 = same, 3 = worst, 4 = much worse)
Time Frame
6 and 12 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient ≥ 45 years of age of either sex.
Primary knee OA of the medial or lateral femoro-tibial compartment documented according to ACR criteria with symptoms, at screening, from at least 3 months.
KL radiological grade 2-3.
Antero-posterior view X-Ray image of the target knee
Pain intensity at screening in the target knee ≥40 mm and <80 mm measured by Visual Analogue Scale (VAS), and ≤ 20 mm in the contralateral knee.
Able to understand and willing to comply with study procedures.
Able to provide informed consent.
Exclusion Criteria:
BMI ≥ 30 kg/m2.
Pregnant or lactating women. Women of child-bearing age not using effective contraception.
Severe inflammation of the target knee.
Previous surgery in the target knee, including arthroscopy.
Subjects with any musculoskeletal condition affecting the target knee that would impair the proper evaluation
Patients with joint inflammatory disease, microcrystalline arthropathies and significant osteoarthritis symptoms in other joints apart from the knee, and which require pharmacological treatment.
Underlying disease considered by the investigator that might interfere with the development and evaluation study.
Subjects with venous or lymphatic stasis in the relevant limb.
Previous administration of any of the following treatments: hyaluronic acid i.a. (last year); steroids i.a. or joint lavage (last 3 months), glucosamine sulfate, chondroitin sulfate or diacerein (last 3 months), NSAIDs (last 14 days), any investigational drug (last month) or its administration during this study.
Pain in other parts of the body greater than the knee pain that could interfere with the evaluation.
Any pathology that, under investigator judgement, interfere with the administration or assessment.
Patients with known hypersensitivity to SH or paracetamol.
Patients in waiting list for surgery.
Patients awaiting disablement assessment.
Previous participation in this protocol
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alicia Navarro, MSc
Phone
34 91 745 25 20
Email
alicia.navarro@alphabioresearch.com
First Name & Middle Initial & Last Name or Official Title & Degree
Roger Daga, MSc
Phone
34 91 745 25 20
Email
roger.daga@alphabioresearch.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mercedes Gimeno, PhD
Organizational Affiliation
Tedec Meiji
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Carlos Gavin, PhD
Organizational Affiliation
Hospital Uiversitario Fundacion Alcorcón
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital General de Elche
City
Elche
State/Province
Alicánte
ZIP/Postal Code
03203
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisco J Navarro, PhD
Facility Name
Hospital de la Marina Baixa de Villajoyosa
City
Villajoyosa
State/Province
Alicánte
ZIP/Postal Code
03570
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose C Rosas, PhD
Facility Name
Hospital Universitario Fundación Alcorcón
City
Alcorcón
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Gavin, PhD
Facility Name
Hospital Universitario Reina Sofia
City
Córdoba
ZIP/Postal Code
10004
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miguel A Carcuel, PhD
Facility Name
Complejo Hospitalario La Coruña
City
La Coruña
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisco J Blanco, PhD
Facility Name
Clinica Universitaria de Navarra
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria J Cuadrado, PhD
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafael Otero, PhD
Facility Name
Hospital Universitario Fundación Jiménez Díaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emilio Calvo, PhD
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose L Pablos, PhD
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enrique Gómez, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
34321921
Citation
Gavin C, J Blanco F, L Pablos J, Caracuel MA, Rosas J, Gomez-Barrena E, Navarro F, Coronel MP, Gimeno M. One-Year, Efficacy and Safety Open Label Study, with a Single Injection of a New Hyaluronan for Knee OA: The SOYA Trial. J Pain Res. 2021 Jul 21;14:2229-2237. doi: 10.2147/JPR.S321841. eCollection 2021.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of Intraarticular Sodium Hyaluronate Single Injection in Patients With Osteoarthritis of the Knee
We'll reach out to this number within 24 hrs