Osteoarthritis, KneeNCT06528600
Comparative Study of Two Hyaluronic Acid Formulation in the Management of Knee Osteoarthritis
A study testing Hymovis ONE and Monovisc in people with Osteoarthritis, Knee, run by Fidia Farmaceutici s.p.a. at 19 sites in Italy.
Trial summary
The objective of this randomized, double-blind, active-controlled, non-inferiority study is to compare the effectiveness and safety of a single injection of Hymovis ONE®, a sodium hyaluronate formulation, to Monovisc™, another sodium hyaluronate formulation, for the treatment of pain from osteoarthritis (OA) of the… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Hymovis ONE and Monovisc
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 19 sitesItaly
- Study dates
- 16 Sep 2020to 15 Jun 2024
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female and male subjects ≥ 40 and ≤ 75 years of age
- Body mass index (BMI) ≥20 and <35 kg/m2
- Tegner score ≥3
- Subjects with primary knee OA of the medial or lateral femorotibial compartment with symptoms at screening and for at least 3 months prior to screening according to American College of Rheumatology (ACR) criteria and who have not responded to conservative non-pharmacologic treatment or simple analgesic regimens
- Subjects with Kellgren-Lawrence (K-L) radiological grade 2 or 3 in the target knee
- Subjects with at least one X-Ray image of the target knee taken at screening or within 6 months prior to the screening.
Show all 14Show fewer
- Subjects with OA pain intensity meeting the criteria below:
- Subjects demonstrating at both the screening (V0) and the baseline (V1) visit, pain intensity in the target knee of 2 - 3 and in the contralateral knee 0 as measured by the WOMAC LK3.1 A1 Pain subscale (walking on a flat surface)
- Willingness to discontinue oral and topical analgesics including NSAIDs and accept "rescue" paracetamol as the only medicine for joint pain prior to the injection and throughout the study. "Rescue" medication will be discontinued 24 hours before any study visit
- Subjects able to understand and willing and able to comply with study procedures
- Subjects able to provide informed consent
- If female of childbearing potential, must have a negative pregnancy test at screening and agree to use a reliable form of contraception throughout the study*.
- Note: To be considered of non-childbearing potential, females must be surgically sterile or postmenopausal for at least 1 year.
- Highly effective birth control methods include: combined hormonal contraception containing estrogen 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 ormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence.
Who cannot join
- Inability to perform a 50-foot walk test
- Subjects with secondary (post-traumatic) knee OA of the target joint
- Subjects with K-L radiological grade 1 or 4 in the target knee
- Subjects with known X-ray findings of acute fractures, severe loss of bone density, avascular necrosis, and /or severe bone or joint deformity in the target knee
- Clinically apparent tense effusion of the target knee on examination (determined by either a positive bulge sign or ballottement of the patella (patellar tap))
- Subjects with osteonecrosis of either knee
Show all 42Show fewer
- Subjects with a history of knee joint replacement or arthroplasty of the target knee
- Subjects with a history of arthroscopy of the target knee in the past 6 months
- Subjects with a history of osteotomy or surgery of the target or contralateral knee and any other weight-bearing joint that would have interfered with knee assessment
- Subjects with acute, recurrent synovitis, or any inflammatory conditions in the target knee
- Subjects with any significant injury to the target knee in the last 6 months (as per Investigator judgment)
- Subjects with any musculoskeletal condition affecting the target knee that would impair the proper assessment of the
- Investigational Medical Device (IMD) performance in the target knee as assessed by the Investigator such as:
- severe varus/valgus deformity (>15°)
- predominantly patellofemoral pain syndrome
- Subjects with health condition associated with pain which may interfere with study variables evaluation
- Subjects with a known history or present evidence of conditions which may affect the target knee assessments, like rheumatic disease, lupus arthropathy, infective or metabolic joint diseases; recurrent clinical chondrocalcinosis; crystal arthropathies; osteoarticular pathologies differing from arthrosis; acromegaly; haemochromatosis; Wilson's disease; primary osteochondromatosis; heritable disorders; collagen gene mutations
- Subjects with gout or calcium pyrophosphate (pseudogout) diseases of the target knee with flare-ups within 6 months prior to screening
- Subjects with fibromyalgia, pes anserine bursitis, lumbar radiculopathy and/or neurogenic or vascular claudication
- Subject with significant anterior knee pain due to the diagnosed isolated patellar-femoral syndrome or chondromalacia in the target knee
- Subjects with symptomatic OA of the hips, spine or ankle that interferes with the evaluation of the target knee
- Subjects with venous or lymphatic stasis in the relevant limb
- Subjects with a history of the following treatments:
- IA corticosteroids in any joints in the past 3 months
- Systemic (both oral and parenteral) and topical corticosteroids at the target knee in the past 30 and 90 days, respectively
- Topical anti-inflammatory agents and analgesics applied at the target knee in the past 48 hours
- Viscosupplementation with hyaluronic acid or joint-lavage in the target knee in the past 6 months
- Physical therapy started in the past 3 months in the target knee. Subjects having started a physical therapy from more than 3 months can take part in the study
- Change in the dosage of symptomatic slow-acting supplements for OA such as glucosamine, chondroitin sulfate, diacerhein, or other supplements such as avocado or soya extracts, etc. in the last month
- Chronic or recurrent use of narcotic analgesics
- Subjects with a history of chronic or recurrent use of NSAIDs/analgesics/narcotics because of diseases different from OA of the target knee
- Subjects treated with agents which alter the perception of pain such as hypnotics, muscle relaxants, anxiolytics if the intake has started less than 8 days before screening
- Subjects with a history of recurrent severe allergic or immune-mediated reactions or other immune disorders
- Subjects with vascular insufficiency of lower limbs or peripheral neuropathy severe enough to interfere
- Subjects with active liver disease
- Subjects with any clinically significant laboratory values which, based on investigator judgment and subject clinical history, may affect study evaluation
- Subjects who currently use heparin or anti-vitamin K (e. g. crystalline warfarin) anticoagulant therapy
- Subjects with infections, wounds, bruising, disease or trauma in the area of the injection site or joint
- Subjects with suspected or known history of hypersensitivity to paracetamol, lidocaine, hyaluronic acid or to hyaluronate preparations or gram-positive bacterial proteins
- Subjects with any surgical procedures scheduled in the next 6 months
- Subjects who have participated in a clinical study or investigation in the last 3 months
- Pregnant or lactating women, and women of childbearing potential unwilling to use adequate contraception and conduct a pregnancy test at screening.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Italy19 sites
Ospedale S. Maria Borgo Val di Taro - AUSL Parma U.O. Ortopedia e Traumatologia
Borgo Val di Taro, PR, 43043
Fondazione Poliambulanza , Istituto Ospedaliero UO di Ortopedia e Traumatologia
Brescia, BS, 25124
A.O.R.N. S. Anna e S. Sebastiano U.O.C. Ortopedia e Traumatologia
Caserta, CE, 81100
Azienda ULSS 2 Marca Trevigiana - Ospedale di Conegliano U.O.C. Ortopedia e Traumatologia
Conegliano, TV, 31015
A.O. Ospedale Santa Croce e Carle S.C. Ortopedia e Traumatologia
Cuneo, CN, 12100
ASST Valcamonica U.O.C. Ortopedia
Esine, BS, 25040
U.O. Ortopedia e Traumatologia Casa di Cura
Maddaloni, CE, 81024
A.O. Ospedale Cardarelli I Ortopedia
Naples, 80131
AOU Federico II Napoli UOC Ortopedia e Traumatologia
Naples, 80131
P.O. Ospedale del Mare ASL 1 Napoli U.O.C. Ortopedia
Naples, 80131
A.O.U. " Maggiore della Carità" S.C. di Ortopedia e Traumatologia
Novara, 28100
Azienda Ospedaliero-Universitaria di Parma U.O. Clinica Ortopedica
Parma, PR, 43126
Fondazione IRCCS Policlinico San Matteo Pavia U.O.C. Ortopedia e Traumatologia
Pavia, PV, 27100
Policlinico universitario Campus Biomedico
Roma, RO, 00128
Ospedale San Giovanni Calibita Fatebenefratelli - Isola Tiberina U.O.C. di Ortopedia e Traumatologia
Roma, RO, 00186
Ospedale Santo Spirito in Sassia - ASL Roma 1 Ortopedia e Traumatologia
Roma, RO, 00193
A.O. Città della Salute e della Scienza - Presidio CTO (Centro Traumatologico Ortopedico) S.C. Ortopedia e Traumatologia 1 U
Torino, TO, 10126
AOU Città della Salute e della Scienza di Torino -Ospedale Molinette S.C. Medicina Fisica e Riabilitazione U Dip. Ortopedia Traumatologia e Riabilitazione
Torino, TO, 10126
Presidio Sanitario Ospedale Cottolengo Ortopedia
Torino, TO, 10126
About this study
Official title: A Randomized, Double-Blind, Active Controlled, Multi-Center, Non- Inferiority Study of One-injection of Hymovis ONE (32 mg/4ml) Against Currently Approved 1-injection Regimen of Monovisc in Symptomatic Relief of Osteoarthritis of the Knee
The objective of this randomized, double-blind, active-controlled, non-inferiority study is to compare the effectiveness and safety of a single injection of Hymovis ONE®, a sodium hyaluronate formulation, to Monovisc™, another sodium hyaluronate formulation, for the treatment of pain from osteoarthritis (OA) of the knee in patients who have not responded to non-pharmacological therapies or analgesic regimens. This study consists of a 2-week period for screening, one baseline treatment visit, and a 26- week evaluation phase. Subjects will be randomized to receive a single intra-articular (IA) injection of either Hymovis ONE® or Monovisc™ into the knee using an 18-20 gauge needle.
Read the detailed description
This is a multi-center, randomized, double-blind, active comparator-controlled, non-inferiority study to assess the efficacy and safety of a single injection of Hymovis ONE® for the relief of pain in subjects with OA of the knee by establishing its non-inferiority to Monovisc™.
The entire study will last approximately 19 months. Patients will participate in the study for approximately 28 weeks (from screening to the last visit).
The study is designed to compare the effectiveness and safety of a single injection of Hymovis ONE® to a single injection of Monovisc™. Both products are high molecular weight HA preparations, specifically sodium hyaluronate from bacterial fermentation, supplied sterile as a single dose of 4 ml in a 5 ml syringe.
Subjects will undergo an evaluation consisting of a thorough discussion of medical history, demographics, followed by a physical examination and vital signs (blood pressure and heart rate) measurement.
The evaluation of their activity level through the Tegner activity level scale, a graduated list of ADLs, recreation, and competitive sports will be performed. The patient is asked to select the level of participation that best describes their current level of activity through an Investigator's interview. The Tegner activity level scale is filled in by Investigator.
In this study, one single IA injection of Hymovis ONE® or Monovisc™ will be performed at the investigational site, under the tight supervision of an experienced treating specialist. Therefore, there are no expected risks of misuse in the administration of the investigational products according to treatment schedule defined in the study protocol. Furthermore, the use of only one IA injection should further contribute to limit the risk of adverse effects. Therefore, it is expected that benefits from participation in this study will outweigh the potential risks.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Hymovis ONE, Monovisc
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hymovis ONEDevice
Single injection of Hymovis ONE®, a sodium hyaluronate formulation, for the treatment of pain from osteoarthritis (OA) of the knee in patients who have not responded to non-pharmacological therapies or analgesic regimens
MonoviscDevice
Single injection of Monovisc™ a sodium hyaluronate formulation, for the treatment of pain from osteoarthritis (OA) of the knee in patients who have not responded to non-pharmacological therapies or analgesic regimens
| Study group | Role | What they receive |
|---|---|---|
| Hymovis One | Experimental | Treatment with 4 mL of Hymovis ONE® in the Intra-articular space Receives: Device: Hymovis ONE |
| Monovisc | Active comparator | Treatment with 4 mL of Monovisc™ in the Intra-articular space Receives: Device: Monovisc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief compared to baseline
Change From Baseline (CFB) in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) LK3.1 A1 Pain subscale (walking on a flat surface) score
Measured: week 12
Secondary outcomes (9)
Patient respons to treatment
"Patient Success" is defined by OMERACT-OARSI criteria:
(1) improvement in pain or physical function ≥50% and an absolute change ≥20; or (2) improvement of ≥20% with an absolute change of≥ 10 in at least two of the following three categories: pain, physical function, and patient's global assessment
Measured: Week 12 and 26
Pain relief compared to baseline
Change from Baseline (CFB) in the Pain subscale in WOMAC LK3.1
Measured: Week 26
Joint Stiffness compared to baseline
Change from Baseline (CFB) in the WOMAC LK3.1 Stiffness
Measured: Week 26
Joint Function compared to baseline
Change from Baseline (CFB) in the WOMAC LK3.1 Function
Measured: Week 26
Patient quality of life
Evaluation through SF-12 questionnaire
Measured: Weeks 4,12 and 26
Patient Global Assessment (PGA)
Evaluation of disease severity measured by patient using a 0-100 Visual Analogue Scale (VAS) as a Change From Baseline
Measured: Weeks 4,12 and 26
Clinical Observer Global Assessment (COGA)
Evaluation of disease severity measured by clinician using a 0-100 Visual Analogue Scale (VAS) as a Change From Baseline
Measured: Weeks 4,12 and 26
Rescue paracetamol use
evaluation of paracetamol consumption during the study duration through a patient diary
Measured: up to 26 weeks
Safety of the treatment. Number of patient with treatment related adverse events
Safety evaluation by tracking the number of adverse events correlated to treatment at each visit
Measured: up to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start16 Sep 2020
- Primary completion15 Mar 2024
- Study completion15 Jun 2024
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-center, randomized (1:1 allocation Hymovis ONE®: Monovisc™), double-blind, active comparator-controlled, non-inferiority study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fidia Farmaceutici s.p.a.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528600
- Sponsor's protocol ID
- EQE9-18-01
- Status last verified
- Jul 2024
- First submitted
- 8 May 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ruosi C, Longo UG, Giordan N, Saracino L, Minetto MA, Busso C, Migliaccio N, Melchior C, Guardoli A, Vaienti E, Scita G, Atzori F, Chitoni G, Orabona N, Benazzo F. Single-injection hyaluronic acid treatment demonstrates non-inferiority in the relief of symptomatic knee osteoarthritis: A randomized double-blind, multi-center controlled study. Osteoarthr Cartil Open. 2026 Feb 5;8(2):100752. doi: 10.1016/j.ocarto.2026.100752. eCollection 2026 Jun.
PubMed 41756523
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Active Controlled, Multi-Center, Non- Inferiority Study of One-injection of Hymovis ONE (32 mg/4ml) Against Currently Approved 1-injection Regimen of Monovisc in Symptomatic Relief of Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT06528600
- Acronym / sponsor ID
- EQE9-18-01
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Fidia Farmaceutici s.p.a.Industry (pharma, biotech, devices)
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 30 Jul 2024 (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 objective of this randomized, double-blind, active-controlled, non-inferiority study is to compare the effectiveness and safety of a single injection of Hymovis ONE®, a sodium hyaluronate formulation, to Monovisc™, another sodium hyaluronate formulation, for the treatment of pain from osteoarthritis (OA) of the knee in patients who have not responded to non-pharmacological therapies or analgesic regimens. This study consists of a 2-week period for screening, one baseline treatment visit, and a 26- week evaluation phase. Subjects will be randomized to receive a single intra-articular (IA) injection of either Hymovis ONE® or Monovisc™ into the knee using an 18-20 gauge needle.
Detailed description
This is a multi-center, randomized, double-blind, active comparator-controlled, non-inferiority study to assess the efficacy and safety of a single injection of Hymovis ONE® for the relief of pain in subjects with OA of the knee by establishing its non-inferiority to Monovisc™.
The entire study will last approximately 19 months. Patients will participate in the study for approximately 28 weeks (from screening to the last visit).
The study is designed to compare the effectiveness and safety of a single injection of Hymovis ONE® to a single injection of Monovisc™. Both products are high molecular weight HA preparations, specifically sodium hyaluronate from bacterial fermentation, supplied sterile as a single dose of 4 ml in a 5 ml syringe.
Subjects will undergo an evaluation consisting of a thorough discussion of medical history, demographics, followed by a physical examination and vital signs (blood pressure and heart rate) measurement.
The evaluation of their activity level through the Tegner activity level scale, a graduated list of ADLs, recreation, and competitive sports will be performed. The patient is asked to select the level of participation that best describes their current level of activity through an Investigator's interview. The Tegner activity level scale is filled in by Investigator.
In this study, one single IA injection of Hymovis ONE® or Monovisc™ will be performed at the investigational site, under the tight supervision of an experienced treating specialist. Therefore, there are no expected risks of misuse in the administration of the investigational products according to treatment schedule defined in the study protocol. Furthermore, the use of only one IA injection should further contribute to limit the risk of adverse effects. Therefore, it is expected that benefits from participation in this study will outweigh the potential risks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Multi-center, randomized (1:1 allocation Hymovis ONE®: Monovisc™), double-blind, active comparator-controlled, non-inferiority study
| Arm | Type | Receives |
|---|---|---|
| Hymovis One | Experimental | Device: Hymovis ONETreatment with 4 mL of Hymovis ONE® in the Intra-articular space |
| Monovisc | Active comparator | Device: MonoviscTreatment with 4 mL of Monovisc™ in the Intra-articular space |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Female and male subjects ≥ 40 and ≤ 75 years of age
- Body mass index (BMI) ≥20 and <35 kg/m2
- Tegner score ≥3
- Subjects with primary knee OA of the medial or lateral femorotibial compartment with symptoms at screening and for at least 3 months prior to screening according to American College of Rheumatology (ACR) criteria and who have not responded to conservative non-pharmacologic treatment or simple analgesic regimens
- Subjects with Kellgren-Lawrence (K-L) radiological grade 2 or 3 in the target knee
Key exclusion criteria (42 listed)
- Inability to perform a 50-foot walk test
- Subjects with secondary (post-traumatic) knee OA of the target joint
- Subjects with K-L radiological grade 1 or 4 in the target knee
- Subjects with known X-ray findings of acute fractures, severe loss of bone density, avascular necrosis, and /or severe bone or joint deformity in the target knee
- Clinically apparent tense effusion of the target knee on examination (determined by either a positive bulge sign or ballottement of the patella (patellar tap))
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 |
|---|---|---|
| Hymovis ONESingle injection of Hymovis ONE®, a sodium hyaluronate formulation, for the treatment of pain from osteoarthritis (OA) of the knee in patients who have not responded to non-pharmacological therapies or analgesic regimens | Device | Hymovis One |
| MonoviscSingle injection of Monovisc™ a sodium hyaluronate formulation, for the treatment of pain from osteoarthritis (OA) of the knee in patients who have not responded to non-pharmacological therapies or analgesic regimens | Device | Monovisc |
Primary outcome
Pain relief compared to baseline
Time frame: week 12
Change From Baseline (CFB) in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) LK3.1 A1 Pain subscale (walking on a flat surface) score
9 secondary outcomes
Patient respons to treatment
Time frame: Week 12 and 26
Pain relief compared to baseline
Time frame: Week 26
Joint Stiffness compared to baseline
Time frame: Week 26
Joint Function compared to baseline
Time frame: Week 26
Patient quality of life
Time frame: Weeks 4,12 and 26
Patient Global Assessment (PGA)
Time frame: Weeks 4,12 and 26
Clinical Observer Global Assessment (COGA)
Time frame: Weeks 4,12 and 26
Rescue paracetamol use
Time frame: up to 26 weeks
Safety of the treatment. Number of patient with treatment related adverse events
Time frame: up to 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Derived from this study: PubMed 41756523Ruosi C, Longo UG, Giordan N, Saracino L, Minetto MA, Busso C, Migliaccio N, Melchior C, Guardoli A, Vaienti E, Scita G, Atzori F, Chitoni G, Orabona N, Benazzo F. Single-injection hyaluronic acid treatment demonstrates non-inferiority in the relief of symptomatic knee osteoarthritis: A randomized double-blind, multi-center controlled study. Osteoarthr Cartil Open. 2026 Feb 5;8(2):100752. doi: 10.1016/j.ocarto.2026.100752. eCollection 2026 Jun.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hymovis ONE and Monovisc in people with Osteoarthritis, Knee, run by Fidia Farmaceutici s.p.a. at 19 sites 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 14 inclusion and 42 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: finished, as of the sponsor's last update on 30 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 19 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain relief compared to baseline (time frame: week 12). 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 NCT06528600, 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 30 Jul 2024.