search
Back to results

An Effectiveness and Safety 6 Months Study of 3 Injections One Week Apart of SYNOLIS VA 40/80 in the Treatment of Symptomatic Knee Osteoarthritis

Primary Purpose

Osteo Arthritis Knee

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
SYNOLIS VA 40/80
Sponsored by
Aptissen SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteo Arthritis Knee focused on measuring Osteoarthritis, Knee Osteoarthritis, Hyaluronic acid

Eligibility Criteria

35 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient between 35 and 75 years old Patients with knee osteoarthritis. The diagnosis is based on the following American College of Rheumatology (ACR) classification: Knee pain Positive radiography (presence of osteophytes) Morning stiffness < 30 min and/or crepitus while walking Symptoms related to knee osteoarthritis for at least 6 months Treatment failure (i.e. ineffective response) with analgesics and/or NSAIDs or intolerance to NSAIDs or low-grade opioids Kellgren-Lawrence radiographic stage: I - III (pre-inclusion radiography) VAS pain index score ≥ 40 mm (VAS 0-100 mm) on the knee to be treated Contralateral knee pain < 10 mm (VAS) compared to treated knee Patient signed inform consent form Exclusion Criteria: Inability to understand the study or language used to be informed/sign the consent Participation in another clinical trial within 4 weeks prior to the start of the trial, and commitment to non-participation within 4 weeks following the end of the trial Intraarticular injection of hyaluronic acid in target knee within the 6 months prior to inclusion Patient who has received an intra-articular (IA) or intra-muscular (IM) steroid injection within the 3 months prior to inclusion or has taken oral corticosteroids within the month prior to inclusion Joint, bone, ligament, or any local or loco-regional surgery of the leg involved, arthroscopic operation on the target knee within the 3 months prior to inclusion Any recent trauma to the leg involved, including a sprain, dislocation within the 3 months prior to inclusion Rheumatoid arthritis, joint condition or any other inflammation and arthritis Lupus Dermatological disorder or any epidermal conditions that prevent an intraarticular injection Visible remarkable joint effusion of the target knee during physical examination evidenced by a protuberance or positive ballottement of the patella Evidence of a subchondral fracture, meniscal lesion, presence of bone or cartilage fragments, horizontal meniscal lesion tear (FLAP) in the target knee Osteonecrosis (1 or both knees) Daily dosage > 101 mg of acetylsalicylic acid as part of cardiovascular preventive treatment (antithrombotic). If dose < 101 mg, must be maintained during the study Known intolerance/hypersensitivity/allergy to any of the components in either product, SYNOLIS VA Fibromyalgia Patient of childbearing potential, pregnant or breast-feeding known at inclusion or in the planning phase during the study unless willing to use contraceptives through the whole duration of the study Excessive and repeated consumption of alcohol or illicit substances Any medical condition that may interfere with the proper conduct of the study (including any surgery or hospitalisation)

Sites / Locations

  • Carolina Medical Center
  • SPORTO oddzial na ulicy Miedzianej
  • SPORTO oddzial na ulicy Książka (2nd site location)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SYNOLIS VA 40/80

Arm Description

SYNOLIS VA 40/80 (hyaluronic acid 40 mg, sorbitol 80 mg), intra-articular injection

Outcomes

Primary Outcome Measures

Difference in total Western Ontario and McMaster Universities Arthritis index (WOMAC) score total between D168 and inclusion visit.
The Western Ontario and McMaster Universities Arthritis index (WOMAC) is a 24-item, condition-specific questionnaire available in a 5-point Likert and 100 mm visual analog scale (VAS) as well as an 11-box numerical rating scale, composed of three subscales: pain (5 questions), stiffness (2 questions) and physical function (17 questions). VAS was used in this study, with a score of 0 for no pain and 100 mm for the worst pain one can image)

Secondary Outcome Measures

Change in pain measurements, assessed using the Western Ontario and McMaster Universities Arthritis (WOMAC) pain severity index, as compared to D0
The Western Ontario and McMaster Universities Arthritis index (WOMAC) is a 24-item, condition-specific questionnaire available in a 5-point Likert and 100 mm visual analog scale (VAS) as well as an 11-box numerical rating scale, composed of three subscales: pain (5 questions), stiffness (2 questions) and physical function (17 questions). VAS was used in this study, with a score of 0 for no pain and 100 mm for the worst pain one can image)
Change in the Western Ontario and McMaster Universities Arthritis (WOMAC) functional severity index, as compared to D0
The Western Ontario and McMaster Universities Arthritis index (WOMAC) is a 24-item, condition-specific questionnaire available in a 5-point Likert and 100 mm visual analog scale (VAS) as well as an 11-box numerical rating scale, composed of three subscales: pain (5 questions), stiffness (2 questions) and physical function (17 questions). VAS was used in this study, with a score of 0 for no pain and 100 mm for the worst pain one can image)
Change in the Western Ontario and McMaster Universities Arthritis (WOMAC) stiffness severity index, as compared to D0
The Western Ontario and McMaster Universities Arthritis index (WOMAC) is a 24-item, condition-specific questionnaire available in a 5-point Likert and 100 mm visual analog scale (VAS) as well as an 11-box numerical rating scale, composed of three subscales: pain (5 questions), stiffness (2 questions) and physical function (17 questions). VAS was used in this study, with a score of 0 for no pain and 100 mm for the worst pain one can image)
Pain at walking on a 100 mm VAS
Percentage of subjects using analgesics
New NSAID / analgesics drugs usage
Measurement of relief satisfaction by the patient
7-point Likert scale (1 point very unsatisfied to 7 points for very satisfied)
Measurement of therapeutic efficacy by the investigator (assessor)
7-point Likert scale (1 point very unsatisfied to 7 points for very satisfied)

Full Information

First Posted
March 21, 2023
Last Updated
April 13, 2023
Sponsor
Aptissen SA
Collaborators
Noblewell
search

1. Study Identification

Unique Protocol Identification Number
NCT05829850
Brief Title
An Effectiveness and Safety 6 Months Study of 3 Injections One Week Apart of SYNOLIS VA 40/80 in the Treatment of Symptomatic Knee Osteoarthritis
Official Title
An Effectiveness and Safety 6 Months Study of 3 Injections One Week Apart of SYNOLIS VA 40/80 in the Treatment of Symptomatic Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
December 29, 2021 (Actual)
Primary Completion Date
January 9, 2023 (Actual)
Study Completion Date
January 9, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aptissen SA
Collaborators
Noblewell

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Multicentre, independent assessment study on SYNOLIS VA 40/80 over a period of 24 weeks

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee
Keywords
Osteoarthritis, Knee Osteoarthritis, Hyaluronic acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SYNOLIS VA 40/80
Arm Type
Experimental
Arm Description
SYNOLIS VA 40/80 (hyaluronic acid 40 mg, sorbitol 80 mg), intra-articular injection
Intervention Type
Device
Intervention Name(s)
SYNOLIS VA 40/80
Intervention Description
Three 2mL injections of SYNOLIS VA 40/80, one week apart
Primary Outcome Measure Information:
Title
Difference in total Western Ontario and McMaster Universities Arthritis index (WOMAC) score total between D168 and inclusion visit.
Description
The Western Ontario and McMaster Universities Arthritis index (WOMAC) is a 24-item, condition-specific questionnaire available in a 5-point Likert and 100 mm visual analog scale (VAS) as well as an 11-box numerical rating scale, composed of three subscales: pain (5 questions), stiffness (2 questions) and physical function (17 questions). VAS was used in this study, with a score of 0 for no pain and 100 mm for the worst pain one can image)
Time Frame
168 days
Secondary Outcome Measure Information:
Title
Change in pain measurements, assessed using the Western Ontario and McMaster Universities Arthritis (WOMAC) pain severity index, as compared to D0
Description
The Western Ontario and McMaster Universities Arthritis index (WOMAC) is a 24-item, condition-specific questionnaire available in a 5-point Likert and 100 mm visual analog scale (VAS) as well as an 11-box numerical rating scale, composed of three subscales: pain (5 questions), stiffness (2 questions) and physical function (17 questions). VAS was used in this study, with a score of 0 for no pain and 100 mm for the worst pain one can image)
Time Frame
up to 168 days
Title
Change in the Western Ontario and McMaster Universities Arthritis (WOMAC) functional severity index, as compared to D0
Description
The Western Ontario and McMaster Universities Arthritis index (WOMAC) is a 24-item, condition-specific questionnaire available in a 5-point Likert and 100 mm visual analog scale (VAS) as well as an 11-box numerical rating scale, composed of three subscales: pain (5 questions), stiffness (2 questions) and physical function (17 questions). VAS was used in this study, with a score of 0 for no pain and 100 mm for the worst pain one can image)
Time Frame
up to 168 days
Title
Change in the Western Ontario and McMaster Universities Arthritis (WOMAC) stiffness severity index, as compared to D0
Description
The Western Ontario and McMaster Universities Arthritis index (WOMAC) is a 24-item, condition-specific questionnaire available in a 5-point Likert and 100 mm visual analog scale (VAS) as well as an 11-box numerical rating scale, composed of three subscales: pain (5 questions), stiffness (2 questions) and physical function (17 questions). VAS was used in this study, with a score of 0 for no pain and 100 mm for the worst pain one can image)
Time Frame
up to 168 days
Title
Pain at walking on a 100 mm VAS
Time Frame
up to 168 days
Title
Percentage of subjects using analgesics
Description
New NSAID / analgesics drugs usage
Time Frame
up to 168 days
Title
Measurement of relief satisfaction by the patient
Description
7-point Likert scale (1 point very unsatisfied to 7 points for very satisfied)
Time Frame
168 days
Title
Measurement of therapeutic efficacy by the investigator (assessor)
Description
7-point Likert scale (1 point very unsatisfied to 7 points for very satisfied)
Time Frame
168 days
Other Pre-specified Outcome Measures:
Title
Safety and tolerability of SYNOLIS VA 40/80 assessed with adverse events monitoring throughout the study duration
Time Frame
168 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient between 35 and 75 years old Patients with knee osteoarthritis. The diagnosis is based on the following American College of Rheumatology (ACR) classification: Knee pain Positive radiography (presence of osteophytes) Morning stiffness < 30 min and/or crepitus while walking Symptoms related to knee osteoarthritis for at least 6 months Treatment failure (i.e. ineffective response) with analgesics and/or NSAIDs or intolerance to NSAIDs or low-grade opioids Kellgren-Lawrence radiographic stage: I - III (pre-inclusion radiography) VAS pain index score ≥ 40 mm (VAS 0-100 mm) on the knee to be treated Contralateral knee pain < 10 mm (VAS) compared to treated knee Patient signed inform consent form Exclusion Criteria: Inability to understand the study or language used to be informed/sign the consent Participation in another clinical trial within 4 weeks prior to the start of the trial, and commitment to non-participation within 4 weeks following the end of the trial Intraarticular injection of hyaluronic acid in target knee within the 6 months prior to inclusion Patient who has received an intra-articular (IA) or intra-muscular (IM) steroid injection within the 3 months prior to inclusion or has taken oral corticosteroids within the month prior to inclusion Joint, bone, ligament, or any local or loco-regional surgery of the leg involved, arthroscopic operation on the target knee within the 3 months prior to inclusion Any recent trauma to the leg involved, including a sprain, dislocation within the 3 months prior to inclusion Rheumatoid arthritis, joint condition or any other inflammation and arthritis Lupus Dermatological disorder or any epidermal conditions that prevent an intraarticular injection Visible remarkable joint effusion of the target knee during physical examination evidenced by a protuberance or positive ballottement of the patella Evidence of a subchondral fracture, meniscal lesion, presence of bone or cartilage fragments, horizontal meniscal lesion tear (FLAP) in the target knee Osteonecrosis (1 or both knees) Daily dosage > 101 mg of acetylsalicylic acid as part of cardiovascular preventive treatment (antithrombotic). If dose < 101 mg, must be maintained during the study Known intolerance/hypersensitivity/allergy to any of the components in either product, SYNOLIS VA Fibromyalgia Patient of childbearing potential, pregnant or breast-feeding known at inclusion or in the planning phase during the study unless willing to use contraceptives through the whole duration of the study Excessive and repeated consumption of alcohol or illicit substances Any medical condition that may interfere with the proper conduct of the study (including any surgery or hospitalisation)
Facility Information:
Facility Name
Carolina Medical Center
City
Warszawa
ZIP/Postal Code
02-757
Country
Poland
Facility Name
SPORTO oddzial na ulicy Miedzianej
City
Łódź
ZIP/Postal Code
09-038
Country
Poland
Facility Name
SPORTO oddzial na ulicy Książka (2nd site location)
City
Łódź
ZIP/Postal Code
91-603
Country
Poland

12. IPD Sharing Statement

Learn more about this trial

An Effectiveness and Safety 6 Months Study of 3 Injections One Week Apart of SYNOLIS VA 40/80 in the Treatment of Symptomatic Knee Osteoarthritis

We'll reach out to this number within 24 hrs