Knee OsteoarthritisNCT06113783
Assessment of Efficacy of a Single Intra-articular Injection of HYALUBRIX 60 in Knee Osteoarthritis
A study testing HYALUBRIX 60 in people with Knee Osteoarthritis, run by Fidia Farmaceutici s.p.a. at 1 site in Italy.
Trial summary
The purpose of this study is to evaluate the effect of one single intra-articular (IA) injection of HYALUBRIX 60® plus physical exercise program (PEP) in terms of pain reduction, compared to PEP alone, in patients with knee osteoarthritis (OA). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- HYALUBRIX 60
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 16 Jun 2022to Mar 2026
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily given informed consent to investigation participation in writing encompassing consent to data recording and verification procedures;
- Male or female subjects aged ≥18 years and ≤70 years with active life-style;
- BMI ≤40 kg/m2;
- Patients affected by knee osteoarthritis, as defined by American College of Rheumatology (ACR) clinical and radiographic criteria for OA of the knee, and meeting the following conditions:
- Kellgren-Lawrence Grade 2 to 3 severity OA of the target knee with presence of osteophytes determined from X-rays of the knee obtained within 6 months from the screening visit; i.e. in the tibio-femoral compartment of the target knee with at least 1 osteophyte and measurable joint space, as diagnosed by standard X-rays (anterior- posterior view [weight bearing extension or semi-flexion] and lateral). In the case that a patient has not a valid X-ray within 6 months prior to screening, the exam is to be performed during the screening period;
- Patients suffering from OA symptoms of the target knee for at least 3 months prior to the screening visit; Note: patients with bilateral OA of the knee will be allowed as long as they can differentiate pain in the target knee, do not need to use analgesics for treatment of their contralateral knee, and do not expect to receive treatment of the contralateral knee during the investigation. In the case that both knees are eligible for the investigation based on pain intensity, the knee with the greater pain VAS score on the WOMAC pain VAS A1 subscale (walking on a flat surface) will be selected as the target knee;
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- Pain ≥50 mm on the WOMAC pain VAS A1 subscale (walking on a flat surface) in the target knee;
- Patients having discontinued use of all systemic analgesic/non-steroidal anti-inflammatory drugs (NSAIDs) therapy for at least 7 days (24 hours for paracetamol) prior to the screening visit and agree not to resume them during the investigation. Note: paracetamol will be provided to patients as rescue medication.
- If female of child-bearing potential, must have a negative urine pregnancy test at the screening visit and use a reliable form of contraception for more than 1 month prior to Screening and throughout the investigation. Note: to be considered females of non-child- bearing potential, females must be surgically sterile or postmenopausal as documented in medical history for at least 1 year. Highly effective birth control methods include: combined hormonal contraception (containing estrogens and progestogen) associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence.*
- Note: According to 4.1 paragraph "Birth control methods which may be considered as highly effective" of the Clinical Trial Facilitation Group (CTFG)/Recommendations related to contraception and pregnancy testing in clinical trials.
Who cannot join
- Radiographic assessment confirming abnormal patellofemoral tracking or articulation or abnormal/excessive patellar subluxation in lateral view;
- Major injury to or disorder of the contralateral knee or other weight-bearing joint that would interfere with the study assessments;
- Secondary OA due to a prior or concomitant condition (e.g., septic arthritis, inflammatory joint disease, gout, articular fracture, major dysplasia, or congenital abnormality, hemochromatosis, etc.);
- Patients who have had arthroplasty at the target knee at any time;
- Surgery in the target knee within the previous 12 months prior to Screening or any planned surgery throughout the duration of the investigation;
- Surgery in the contralateral knee or other weight-bearing joint within the previous 12 months that would interfere with the study assessments;
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- Patients that are candidate for knee replacement within the next 12 months;
- Patients having had diagnostic or surgical knee arthroscopy, or knee lavage in the target knee in the 6 months prior to the screening visit, or patients in which such procedures are planned during the study;
- Patients with total joint replacement implants, unicondylar implants or patellofemoral replacement implants in the study joint;
- Ligament reconstruction of the target knee in the previous 3 years;
- Inflammatory arthropathies such as rheumatoid arthritis, lupus, or psoriatic arthritis;
- Patients with clinically relevant intra-articular effusion of the target knee;
- Episode of gout or calcium pyrophosphate (pseudogout) diseases within 6 months prior to Screening;
- Patients having received:
- Corticosteroids by systemic administration within 30 days prior to the screening visit.
- Inhaled corticosteroids are permitted if the Subject has been on a stable regimen for the past 1 month prior to Screening and remains on this regimen throughout the course of the investigation;
- Analgesic/NSAIDs by systemic administration within 7 days prior to the screening visit;
- Intra-articular drugs within 12 weeks prior to the screening visit;
- Chondroitinsulphate, glucosamine, diacereine, bisphosphonates or matrix metalloproteinase (MMP) inhibitors within 30 days prior to the screening visit;
- Viscosupplementation of the target knee within 6 months prior to the screening visit;
- Paracetamol in the 24 hours prior to the screening visit;
- Treatment with any other investigational product within 3 months prior to the screening visit.
- History of allergic reaction to an intra-articular Hyaluronic acid injection;
- Known hypersensitivity (allergy) to gram positive bacterial proteins;
- Inability to perform the Timed Up and Go (TUG) test;
- X-ray findings of acute fractures, severe loss of bone density, avascular necrosis and/or severe deformity;
- Axial deviation of the lower limbs greater than 20 degrees in valgus or varus on standing X-ray, ligamentous laxity, or meniscal instability as per study investigator(s);
- Significant surgery of lower limbs (hip, ankle, foot) that may interfere with knee assessments;
- Patients with any musculoskeletal condition affecting the target knee that would impair assessment of the effectiveness in the target knee (e.g. Paget's disease of bone);
- Patients with significant pain outside the target knee, including significant hip or back pain;
- Chronic use of analgesia for pain (including pain in the other knee or any other joint) that may interfere with the evaluations of the test knee (such as possible use of rescue medication for these other conditions);
- Known allergies to paracetamol and hyaluronan preparations;
- Recurrent medical history of severe allergic or immune-mediated reactions;
- Active infection or skin diseases in the area of the potential injection site or joint;
- Any dermatological disease overlying the study joint that would contraindicate injections or aspirations;
- Peripheral neuropathy that would be severe enough to interfere with the evaluation of the subject;
- Psychological status (e.g., anxiety, depression, poor sleep quality, pain catastrophizing, etc.) that may interfere with functional assessment of the target knee;
- Vascular insufficiency of lower limbs that is severe enough to interfere with the evaluation of the subject;
- Any concomitant disease(s) or condition(s) that may interfere with the free use and evaluation of the affected knee for the 12 months course of the investigation (cancer, other rheumatic diseases, gout, severe congenital defects, etc.);
- Continued participation in an experimental drug/device study or any clinical trial within the previous 8 weeks prior to Screening. Subjects must have fully completed participation in an experimental drug/device study of any clinical trial at least 8 weeks prior to screening;
- Pregnancy, breastfeeding, planned conception, premenopausal women who have not had tubal ligation, hysterectomy, or are unwilling or unable to utilize contraceptive measures (or contraception);
- Prior history of any malignancy with the exception of basal cell carcinoma of the skin treated more than 2 years prior to Screening;
- Significant bleeding diathesis;
- Patients who are not able to comply with study procedures or who are likely to be noncompliant or uncooperative during the study according to the investigator's opinion.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
UOC Medicina Fisica e Riabilitativa SMC09, AOU Policlinico Umberto I, Rome, Italy
Roma, 00161
Valter Santilli, MD
About this study
Official title: A Post-market, Randomized, Controlled Clinical Investigation to Assess the Efficacy of HYALUBRIX 60® Intra-articular Injection in the Symptomatic Relief of Knee Osteoarthritis
The purpose of this study is to evaluate the effect of one single intra-articular (IA) injection of HYALUBRIX 60® plus physical exercise program (PEP) in terms of pain reduction, compared to PEP alone, in patients with knee osteoarthritis (OA).
Read the detailed description
Knee Osteoarthritis (OA) is one of the primary causes of pain and disability worldwide, associated with functional restrictions, morphological changes in the subchondral bone, articular cartilage degeneration and damage to the surrounding soft tissue. [Heiden TL, 2009; Di Cesare PE, 2009, Fernandes L, 2013].
In the degradation of articular cartilage, functional limitation and pain, underlies the quantitative and qualitative alteration of hyaluronic acid (HA), the main component of synovial fluid and cartilage, in a pathophysiological process influenced by a wide variety of risk factors [Balazs, E.A, 1993]. In OA patients, HA is depolymerized and eliminated faster than in healthy subjects, due to chronic inflammation [Legré-Boyer, V., 2015]. HA concentration is significantly decreased in patients with end-stage knee OA [Bagga, H et al, 2006].
HA used intra-articularly in the treatment of OA is known to increase viscosity of the synovial fluid, facilitate gliding via layer formation on the cartilage and protect soft tissue from trauma by acting as a shock absorbent [Legré-Boyer et al., 2015; Cooper et al., 2017; Bowman et al., 2018]. HA also soothes the pain and exerts an immunomodulatory effect on inflammatory cells [Pelletier, J.P, 1993]. HA has a delayed onset of action in comparison with IA corticosteroids, but a longer-lasting benefit [Bannuru, R.R., 2009].
HYALUBRIX 60® is a CE-marked medical device of class III consisting in a 1.5% solution of non-modified HA (60mg/4ml) obtained from bacterial fermentation with high molecular weight. HYALUBRIX 60® exhibits a behavior very similar to the synovial fluid that it replaces. In particular, it confers proper rheological properties, trans-synovial fluid buffering, and permeability to metabolites and macromolecules.
This post-market, monocentre, randomized, controlled clinical investigation is designed to enrol a relatively young, active population of subjects with knee OA and to compare responses to treatment with one IA HYALUBRIX 60® injection plus physical exercise program (PEP), versus a PEP alone. Because PEP or exercise programs may be considered the first line standard of care in OA knee pain, particularly in younger, active patients [Nelson AE et al. 2014], the hypothesis of the study is that HYALUBRIX 60® combined to PEP, provides greater relief of pain associated with knee OA in the enrolled study subjects than with use of PEP alone. The primary endpoint pain relief is measured after 2 months, but observation will last up to 12 months and effects on both pain relief and physical function will be evaluated at 1, 2, 6, and 12 months after single injection (in the HYALUBRIX 60® treated arm), through WOMAC index.
Selection of dose was done on the basis of a previous randomised clinical trial (RCT) (Clementi et al, 2018) conducted on 50 patients, that showed no significant difference between the two groups (single injection and injection repeated after 3-4 weeks) for beneficial long-term pain relief and functional improvement in terms of VAS score, WOMAC score and Lequesne index at 1, 3, 6 and 12 months. A clinical improvement was observed as early as at 1 month in each treatment group and continued until 1 year with no difference in the development over time between the two treatment groups.
- Conditions
- Knee Osteoarthritis
- Being tested
- HYALUBRIX 60
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HYALUBRIX 60Device
Also called HYALONE
1.5% solution of non-modified HA (60mg/4ml) obtained from bacterial fermentation with high molecular weight.
| Study group | Role | What they receive |
|---|---|---|
| Group 1- ACTIVE | Experimental | Intra-articular injection at baseline of HYALUBRIX 60® plus PEP 3 times a week at home for the 12 months of observation; Receives: Device: HYALUBRIX 60 |
| Group 2-CONTROL | No intervention | Physical Exercise Program alone 3 times a week at home for the 12 months of observation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain reduction from baseline
Pain intensity will be measured by means of the WOMAC Pain VAS scale (Scale A) (1-100 mm). The mean change in WOMAC Pain VAS score in the target knee from baseline to 2 months will be the primary efficacy endpoint.
Measured: 2 months
Secondary outcomes (8)
Pain reduction from baseline
Pain intensity will be measured by means of the WOMAC Pain VAS scale (Scale A) (1-100 mm). The mean change in WOMAC Pain VAS score in the target knee
Measured: 1,2, 6 and 12 months
Reduction of Stiffness, physical function and overall WOMAC in the target knee from baseline
Stiffness, physical function and overall WOMAC improvement, as change of WOMAC scores (Scale B, C, Total WOMAC) (1-100 mm) in the target knee
Measured: 1,2, 6 and 12 months
Treatment response from baseline
Change in WOMAC Pain, Physical Function and Stiffness subscale in the target knee of 0-30%, 31-50%, 51-70%, 71-90%, >90% or worsening from baseline
Measured: 1, 2, 6 and 12 months
EQ-5D-5L score changes from baseline
EQ-5D is a general, preference-weighted health status instrument that asks patient questions about their overall health status and Health-Related Quality of Life (HRQoL). EQ-5D measures health status using the following 5 dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. EQ-5D has 3L and 5L versions, and 5L could increase the reliability and sensitivity (discriminatory power) while feasibility and potentially reducing ceiling effects, compared with 3L. EQ-5D-5L includes 5 levels of severity in each of five dimensions: no problem, slight problems, moderate problems, severe problems, and extreme problems.
Measured: 2, 6, 12 months
Improvement of physical function from baseline
Improvement of physical function such as strength, balance, and agility as differences of Time Up to Go (TUG) test performance from baseline to 1, 2, 6 and 12 months. The TUG is a transition test that assesses strength, agility and dynamic balance during multiple activities including sit-to-stand, walking short distances and changing direction whilst walking. The TUG measures (in seconds) the time taken to stand up from a standard armchair (approximate seat height of 46 cm, arm height of 65 cm), walk a distance of 3m, turn around, walk back to the chair and sit down.
Measured: 2, 6, 12 months
Rescue medication (paracetamol) daily consumption from baseline
The consumption of daily rescue medication (paracetamol) in the overall study period required for pain relief will be evaluated using a patient diary. The number and percentage of patients who will take at least one dose of rescue medication, as well as the total amount of rescue medication taken over the study, will be analyzed.
Measured: 12 months
Number of subjects that switched to HYALUBRIX 60® Group due to PEP failure
The study provides for subjects randomized to the PEP alone study group to cross over to HYALUBRIX 60® if improvement has not been achieved by the 2-month follow up visit.
Measured: 2 months
Number of Adverse Events related to the treatment
Safety of HYALUBRIX 60® will be evaluated in terms of incidence of treatment-emergent adverse events (TEAEs) over the study period.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start16 Jun 2022
- Primary completionDec 2024 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- post-market, monocentre, randomized, controlled clinical investigation
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fidia Farmaceutici s.p.a.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Valter Santilli, Principal investigator, UOC Medicina Fisica e Riabilitativa SMC09, AOU Policlinico Umberto I, Rome, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113783
- Sponsor's protocol ID
- EQB7-20-02
- Status last verified
- Oct 2023
- First submitted
- 30 Oct 2023
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-market, Randomized, Controlled Clinical Investigation to Assess the Efficacy of HYALUBRIX 60® Intra-articular Injection in the Symptomatic Relief of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06113783
- Acronym / sponsor ID
- EQB7-20-02
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fidia Farmaceutici s.p.a.Industry (pharma, biotech, devices)
- Study start
- 16 Jun 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 2 Nov 2023 (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.
The purpose of this study is to evaluate the effect of one single intra-articular (IA) injection of HYALUBRIX 60® plus physical exercise program (PEP) in terms of pain reduction, compared to PEP alone, in patients with knee osteoarthritis (OA).
Detailed description
Knee Osteoarthritis (OA) is one of the primary causes of pain and disability worldwide, associated with functional restrictions, morphological changes in the subchondral bone, articular cartilage degeneration and damage to the surrounding soft tissue. [Heiden TL, 2009; Di Cesare PE, 2009, Fernandes L, 2013].
In the degradation of articular cartilage, functional limitation and pain, underlies the quantitative and qualitative alteration of hyaluronic acid (HA), the main component of synovial fluid and cartilage, in a pathophysiological process influenced by a wide variety of risk factors [Balazs, E.A, 1993]. In OA patients, HA is depolymerized and eliminated faster than in healthy subjects, due to chronic inflammation [Legré-Boyer, V., 2015]. HA concentration is significantly decreased in patients with end-stage knee OA [Bagga, H et al, 2006].
HA used intra-articularly in the treatment of OA is known to increase viscosity of the synovial fluid, facilitate gliding via layer formation on the cartilage and protect soft tissue from trauma by acting as a shock absorbent [Legré-Boyer et al., 2015; Cooper et al., 2017; Bowman et al., 2018]. HA also soothes the pain and exerts an immunomodulatory effect on inflammatory cells [Pelletier, J.P, 1993]. HA has a delayed onset of action in comparison with IA corticosteroids, but a longer-lasting benefit [Bannuru, R.R., 2009].
HYALUBRIX 60® is a CE-marked medical device of class III consisting in a 1.5% solution of non-modified HA (60mg/4ml) obtained from bacterial fermentation with high molecular weight. HYALUBRIX 60® exhibits a behavior very similar to the synovial fluid that it replaces. In particular, it confers proper rheological properties, trans-synovial fluid buffering, and permeability to metabolites and macromolecules.
This post-market, monocentre, randomized, controlled clinical investigation is designed to enrol a relatively young, active population of subjects with knee OA and to compare responses to treatment with one IA HYALUBRIX 60® injection plus physical exercise program (PEP), versus a PEP alone. Because PEP or exercise programs may be considered the first line standard of care in OA knee pain, particularly in younger, active patients [Nelson AE et al. 2014], the hypothesis of the study is that HYALUBRIX 60® combined to PEP, provides greater relief of pain associated with knee OA in the enrolled study subjects than with use of PEP alone. The primary endpoint pain relief is measured after 2 months, but observation will last up to 12 months and effects on both pain relief and physical function will be evaluated at 1, 2, 6, and 12 months after single injection (in the HYALUBRIX 60® treated arm), through WOMAC index.
Selection of dose was done on the basis of a previous randomised clinical trial (RCT) (Clementi et al, 2018) conducted on 50 patients, that showed no significant difference between the two groups (single injection and injection repeated after 3-4 weeks) for beneficial long-term pain relief and functional improvement in terms of VAS score, WOMAC score and Lequesne index at 1, 3, 6 and 12 months. A clinical improvement was observed as early as at 1 month in each treatment group and continued until 1 year with no difference in the development over time between the two treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- post-market, monocentre, randomized, controlled clinical investigation
| Arm | Type | Receives |
|---|---|---|
| Group 1- ACTIVE | Experimental | Device: HYALUBRIX 60Intra-articular injection at baseline of HYALUBRIX 60® plus PEP 3 times a week at home for the 12 months of observation; |
| Group 2-CONTROL | No intervention | –Physical Exercise Program alone 3 times a week at home for the 12 months of observation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Voluntarily given informed consent to investigation participation in writing encompassing consent to data recording and verification procedures;
- Male or female subjects aged ≥18 years and ≤70 years with active life-style;
- BMI ≤40 kg/m2;
- Patients affected by knee osteoarthritis, as defined by American College of Rheumatology (ACR) clinical and radiographic criteria for OA of the knee, and meeting the following conditions:
- Pain ≥50 mm on the WOMAC pain VAS A1 subscale (walking on a flat surface) in the target knee;
Key exclusion criteria (44 listed)
- Radiographic assessment confirming abnormal patellofemoral tracking or articulation or abnormal/excessive patellar subluxation in lateral view;
- Major injury to or disorder of the contralateral knee or other weight-bearing joint that would interfere with the study assessments;
- Secondary OA due to a prior or concomitant condition (e.g., septic arthritis, inflammatory joint disease, gout, articular fracture, major dysplasia, or congenital abnormality, hemochromatosis, etc.);
- Patients who have had arthroplasty at the target knee at any time;
- Surgery in the target knee within the previous 12 months prior to Screening or any planned surgery throughout the duration of the investigation;
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 |
|---|---|---|
| HYALUBRIX 60Also: HYALONE1.5% solution of non-modified HA (60mg/4ml) obtained from bacterial fermentation with high molecular weight. | Device | Group 1- ACTIVE |
Primary outcome
Pain reduction from baseline
Time frame: 2 months
Pain intensity will be measured by means of the WOMAC Pain VAS scale (Scale A) (1-100 mm). The mean change in WOMAC Pain VAS score in the target knee from baseline to 2 months will be the primary efficacy endpoint.
8 secondary outcomes
Pain reduction from baseline
Time frame: 1,2, 6 and 12 months
Reduction of Stiffness, physical function and overall WOMAC in the target knee from baseline
Time frame: 1,2, 6 and 12 months
Treatment response from baseline
Time frame: 1, 2, 6 and 12 months
EQ-5D-5L score changes from baseline
Time frame: 2, 6, 12 months
Improvement of physical function from baseline
Time frame: 2, 6, 12 months
Rescue medication (paracetamol) daily consumption from baseline
Time frame: 12 months
Number of subjects that switched to HYALUBRIX 60® Group due to PEP failure
Time frame: 2 months
Number of Adverse Events related to the treatment
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Valter Santilli principal investigator
UOC Medicina Fisica e Riabilitativa SMC09, AOU Policlinico Umberto I, Rome, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HYALUBRIX 60 in people with Knee Osteoarthritis, run by Fidia Farmaceutici s.p.a. at 1 site in Italy.
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 10 inclusion and 44 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 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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 Nicola Giordan (+390498232512, ngriordan@fidiapharma.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain reduction from baseline (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2024.