Osteoarthritis, KneeNCT03852914
Efficacy and Safety of Intraarticular Sodium Hyaluronate Single Injection in Patients With Osteoarthritis of the Knee
A study testing Sodium hyaluronate 2% in people with Osteoarthritis, Knee, run by Tedec-Meiji Farma, S.A. at 10 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Sodium hyaluronate 2%
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 10 sitesSpain
- Study dates
- 17 Jan 2019to Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Spain10 sites, 10 recruiting
- Recruiting
Complejo Hospitalario La Coruña
A Coruña, 15006
Francisco J Blanco, PhD
- Recruiting
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, 28922
Carlos Gavin, PhD
- Recruiting
Hospital Universitario Reina Sofia
Córdoba, 10004
Miguel A Carcuel, PhD
- Recruiting
Hospital General de Elche
Elche, Alicánte, 03203
Francisco J Navarro, PhD
- Recruiting
Clinica Universitaria de Navarra
Madrid, 28027
Maria J Cuadrado, PhD
- Recruiting
Hospital Clínico San Carlos
Madrid, 28040
Rafael Otero, PhD
- Recruiting
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Emilio Calvo, PhD
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Jose L Pablos, PhD
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
Enrique Gómez, PhD
- Recruiting
Hospital de la Marina Baixa de Villajoyosa
Villajoyosa, Alicánte, 03570
Jose C Rosas, PhD
About this study
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
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
Read the 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)
- Conditions
- Osteoarthritis, Knee
- Being tested
- Sodium hyaluronate 2%
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium hyaluronate 2%Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Sodium Hyaluronate 2% | Experimental | Each patient will receive a single injection of SH2% Receives: Device: Sodium hyaluronate 2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 and 12 months after treatment
Secondary outcomes (5)
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.
Measured: 6 and 12 months after treatment
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
Measured: 6 and 12 months after treatment
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
Measured: 6 and 12 months after treatment
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.
Measured: 6 and 12 months after treatment
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)
Measured: 6 and 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start17 Jan 2019
- Primary completionOct 2019 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tedec-Meiji Farma, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alpha Bioresearch S.L.
- Responsible party
- Sponsor
- Investigators
- Mercedes Gimeno, PhD, Study chair, Tedec MeijiCarlos Gavin, PhD, Principal investigator, Hospital Uiversitario Fundacion Alcorcón
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03852914
- Sponsor's protocol ID
- TM-SH2%/301
- Status last verified
- Feb 2019
- First submitted
- 22 Feb 2019
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34321921
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03852914
- Acronym / sponsor ID
- TM-SH2%/301
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Tedec-Meiji Farma, S.A.Industry (pharma, biotech, devices)
- Collaborators
- Alpha Bioresearch S.L.
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 25 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Sodium Hyaluronate 2% | Experimental | Device: Sodium hyaluronate 2%Each patient will receive a single injection of SH2% |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium hyaluronate 2%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. | Device | Experimental: Sodium Hyaluronate 2% |
Primary outcome
Change in pain intensity according to VAS (0-100mm)
Time frame: 6 and 12 months after treatment
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.
5 secondary outcomes
Change in function from baseline in the target knee
Time frame: 6 and 12 months after treatment
Change in function from baseline in the target knee
Time frame: 6 and 12 months after treatment
Percentage of patients achieving the Minimally Clinical Important Improvement (MCII)
Time frame: 6 and 12 months after treatment
Percentage of patients achieving the Patient Acceptable Symptoms State (PASS)
Time frame: 6 and 12 months after treatment
Patient and investigator global assessments
Time frame: 6 and 12 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2019.
- Derived from this study: PubMed 34321921Gavin 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.
Related trials for Osteoarthritis, Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mercedes Gimeno, PhD study chair
Tedec Meiji
Carlos Gavin, PhD principal investigator
Hospital Uiversitario Fundacion Alcorcón
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium hyaluronate 2% in people with Osteoarthritis, Knee, run by Tedec-Meiji Farma, S.A. at 10 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alicia Navarro, MSc (34 91 745 25 20, alicia.navarro@alphabioresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity according to VAS (0-100mm) (time frame: 6 and 12 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03852914, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2019.