Glenohumeral OsteoarthritisNCT07520708
Performance and Safety of HyalganBio® Intra-Articular Injections as Add-On to Physical Exercise for Symptomatic Glenohumeral Osteoarthritis
A study testing Hyaluronic acid plus Physical Exercise Program (PEP) in people with Glenohumeral Osteoarthritis, run by Fidia Farmaceutici s.p.a. at 6 sites in Italy.
Trial summary
This investigation evaluates performance and safety of three intra-articular injections of HyalganBio®, combined with a Physical Exercise Program (PEP) in subjects with glenohumeral osteoarthritis. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Glenohumeral Osteoarthritis
- What is being tested?
- Hyaluronic acid plus Physical Exercise Program (PEP)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 6 sitesItaly
- Study dates
- 12 Jul 2024to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged ≥ 45 years and ≤ 85 years.
- Samilson Prieto Grade 1 to 3 of glenohumeral joint confirmed by a X-ray performed in the 6 months before the screening visit (or at the screening if not available in the past 6 months).
- Patient suffering from glenohumeral arthrosis with chronic shoulder pain. Chronic shoulder pain is defined as follows:
- Patient who has persistent pain for a period of at least 6 months, but not exceeding 5 years; or
- Pain perceived by the patient with a frequency of at least 50% of the days in the month preceding the screening visit.
- Presence of pain on movement, in the target shoulder, measured by VAS with a score > 40 mm.
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- VAS for pain in the contralateral shoulder of at least 10 mm less than the target joint.
- Willingness to discontinue oral and topical analgesics including NSAIDs if taken before study inclusion except for assumption of rescue medication (paracetamol) at a maximum dose of 6 tablets of 500 mg a day.
- Patient willing to sign and able to understand the Informed Consent form.
- If female of childbearing potential, must have a negative pregnancy test at screening and agree to use a reliable method of contraception throughout the investigation*.
- 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 hormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence.
Who cannot join
- Presence, at clinical evaluation, of adhesive capsulitis.
- Presence of rotator cuff injury (Massive Rotator Cuff Tears).
- Signs, evident on X-ray of the shoulder, of recent fractures, intense loss of bone density and/or severe deformity.
- Diagnosis of major calcium pyrophosphate dihydrate crystal deposition (CPPD) or shoulder chondrocalcinosis disease.
- Presence of pathology of the cervical vertebrae (capable of altering the clinical evaluation) which, in the three months preceding the screening visit, was symptomatic and required active treatment.
- Presence of any active musculoskeletal disease capable of altering the diagnosis/assessment of the shoulder with pain or presence of pain of any neurological aetiology and acute shoulder infection.
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- Presence of major surgery in arthroscopy in the shoulder under investigation in the 6 months prior to the screening and/or need to plan it.
- Patient undergoing local radiotherapy for breast cancer.
- Patient with rheumatic polymyalgia.
- Patient with diabetes (Type 1 and Type 2 insulin-dependent).
- Active skin cancer (except basal cell carcinoma) or history of skin cancer in the past two years.
- Presence of infection and/or skin pathologies in the injection area.
- Presence of severe gastrointestinal, renal, hepatic, pulmonary, cardiovascular, neurological, immunological or other pathologies that can interfere with the results of the investigation or inability of the patient to comply with the requirements of the investigation.
- Known allergy or suspected allergic reaction to hyaluronate.
- Pharmaceutical products taken orally and containing glucosamine and/or chondroitin sulfate and/or diacerin (eg. Chondrosulf, Structum 500, Dona, Viatril, Fisiodar, Artrodar etc.) in the month prior to the screening visit, unless the dosage was stable for the two months prior to the screening visit.
- Intra-articular corticosteroid injections into the shoulder under investigation in the three months prior to the screening visit.
- Taking oral corticosteroids in the month prior to the screening visit (only inhaled corticosteroids are allowed and chronic oral therapies with daily intake below 7,5 mg).
- Subjects with a history of chronic or recurrent use of NSAIDs/analgesics/narcotics because of diseases different from GH OA.
- Previous use of HA in the shoulder under investigation in the 6 months prior to the screening visit.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Italy6 sites
IRCCS Ospedale Galeazzi
Milan, Italy
Ospedale Cardarelli
Naples, Italy
Ospedale Concordia
Roma, Italy
Policlinico Universitario Campus Biomedico
Roma, Italy
Ospedale Le Molinette
Torino, Italy
Ospedale Le Molinette
Torino
About this study
Official title: A Post-market, Randomized, Controlled, Clinical Investigation to Assess the Performance and Safety of HyalganBio® Intra-articular Injections, as add-on Physical Exercise Program, in the Symptomatic Relief of Glenohumeral Osteoarthritis
This investigation evaluates performance and safety of three intra-articular injections of HyalganBio®, combined with a Physical Exercise Program (PEP) in subjects with glenohumeral osteoarthritis. The main goal is to see whether patients improve shoulder function six months after the first injection, compared with patients who only follow the exercise program. Improvement is measured using the Constant-Murley Score (CMS).
Participants first attend a screening visit and, if they meet all criteria, they are enrolled. Within 14 days, they are randomly assigned to one of two groups: group 1 receives three weekly HyalganBio® injections and performs the PEP three times a week for 60 days, recording adherence in a diary; group 2: performs the same PEP schedule and also records adherence in a diary.
Follow-up visits take place at 2, 4, and 6 months after the first injection, with additional telephone check-ins at 1 and 3 months.
Read the detailed description
This post-market, multicenter, randomized, controlled, open-label clinical investigation aims to evaluate the performance and safety of three intra-articular (IA) injections of HyalganBio® combined with a Physical Exercise Program (PEP) in patients with symptomatic glenohumeral osteoarthritis.
The primary objective is to assess the overall functional clinical improvement at 6 months after the first injection (V1), as measured by the Constant-Murley Score (CMS), comparing HyalganBio® + PEP versus PEP alone.
Eligible subjects are screened at Visit 0 (V0) after signing informed consent. If all inclusion and exclusion criteria are met, enrollment occurs and V0 may coincide with the baseline visit (V1). At V1, within 14 days from screening, participants are randomized 1:1. Group 1 receives three weekly IA injections of HyalganBio® (at V1, V2, V3) and is trained to perform a PEP three times per week for 60 days, recording adherence in a patient diary. Group 2 (control) is trained to perform the same PEP schedule and also reports adherence in a diary. Follow-up visits are planned at 2, 4, and 6 months after V1, with telephone contacts at 1 and 3 months.
- Conditions
- Glenohumeral Osteoarthritis
- Being tested
- Hyaluronic acid plus Physical Exercise Program (PEP)
- Keywords
- Glenohumeral Osteoarthritis, hyaluronic acid, physical Exercise Program (PEP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acid plus Physical Exercise Program (PEP)Device
3 weekly intrarticular injections of HyalganBio® in a concentration of HA 2% (20 mg/2 mL) and PEP.
| Study group | Role | What they receive |
|---|---|---|
| HyalganBio® plus Physical Exercise Program (PEP) | Experimental | 3 weekly intrarticular injections of HyalganBio® hyaluronic acid 20 mg/2 mL, supplied as a pre-filled syringe plus Physical exercise program (PEP) for 3 days a week for a period of 60 days. Receives: Device: Hyaluronic acid plus Physical Exercise Program (PEP) |
| Physical Exercise Program (PEP) | No intervention | Physical exercise program (PEP) for 3 days a week for a period of 60 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance of three intra-articular (IA) injections of HyalganBio® plus Physical Exercise Program (PEP), in terms of overall clinical functional assessment on movement.
The primary outcome of the investigation is the change of the total Constant Murley Score (CMS), a 100-point clinical scoring system. Total score evaluates four main components: A- Pain, B- Activities of daily living, C- Range of movement, D- Power each contributing a specific portion of the total score. Pain accounts for 15 points, daily activities for 20, range of motion for 40 and Power for 25.
Measured: 6 months from baseline.
Secondary outcomes (8)
Clinical functional assessment on movement.
Clinical functional assessment on movement measured by means of the CMS subscores C (range of movement) accounts for 40 points. A higher score reflects better function.
Measured: 2, 4 and 6 months from baseline.
Clinical functional assessment on movement.
Clinical functional assessment on movement measured by means of the CMS total score. Total Constant Murley Score (CMS), a 100-point clinical scoring system. Total score evaluates four main components: A- Pain, B- Activities of daily living, C- Range of movement, D- Power each contributing a specific portion of the total score. Pain accounts for 15 points, daily activities for 20, range of motion for 40 and Power for 25.
Measured: 2 and 4 months from baseline.
Pain reduction
Pain reduction in the target shoulder with a 0-100 mm Visual Analogue Scale (VAS), 0 mm=absence of pain; 100 mm = intollerable pain.
Measured: 2, 4 and 6 months from baseline.
Changes of physical function
Changes of physical function in the target shoulder, evaluated by Disability of the Arm, Shoulder and Hand (DASH). The questionnaire is a 30-item questionnaire that looks at the ability of a patient to perform certain upper extremity activities. Each item is scored on a five-points scale (one to five). The overall DASH score, is summed (possible values: 30-150). The higher is the score the greater is the patient's experience of disability/symptoms.
Measured: 2, 4 and 6 months compared to baseline.
Changes of patient's quality of life.
Changes of patient's quality of life, evaluated by administration of the EuroQol 5-Dimension Questionnaire, (EQ-5D-5L).The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each dimension having 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems.
Measured: 2, 4 and 6 months compared to baseline (V1).
Rescue medication consumption
Rescue medication consumption for shoulder pain reported by the patient in a Patient's Diary. The number and percentage of patients who will take at least one dose of rescue medication up to 6 months from baseline (V1) will be analyzed.
Measured: From baseline to the end of the study at 6 months.
Changes of Clinical Observer Global Assessment (COGA)
Changes of COGA evaluated directly by the Investigator with a 0-100 mm VAS, in the target shoulder. 0= not at all and 100= extremely.
Measured: 2, 4 and 6 months compared to baseline
Number of Participants with treatment-emergent adverse events.
Safety of HyalganBio® will be evaluated in terms of incidence of treatment-emergent adverse events (TEAEs).
Measured: From baseline to the end of the study at 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start12 Jul 2024
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glenohumeral 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 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
- NCT07520708
- Sponsor's protocol ID
- EQP5-23-02
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. 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 Performance and Safety of HyalganBio® Intra-articular Injections, as add-on Physical Exercise Program, in the Symptomatic Relief of Glenohumeral Osteoarthritis
- ClinicalTrials.gov ID
- NCT07520708
- Acronym / sponsor ID
- EQP5-23-02
- Conditions
- Glenohumeral Osteoarthritis
- Keywords
- Glenohumeral Osteoarthritis, hyaluronic acid, physical Exercise Program (PEP)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Fidia Farmaceutici s.p.a.Industry (pharma, biotech, devices)
- Study start
- 12 Jul 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 9 Apr 2026 (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.
This investigation evaluates performance and safety of three intra-articular injections of HyalganBio®, combined with a Physical Exercise Program (PEP) in subjects with glenohumeral osteoarthritis. The main goal is to see whether patients improve shoulder function six months after the first injection, compared with patients who only follow the exercise program. Improvement is measured using the Constant-Murley Score (CMS).
Participants first attend a screening visit and, if they meet all criteria, they are enrolled. Within 14 days, they are randomly assigned to one of two groups: group 1 receives three weekly HyalganBio® injections and performs the PEP three times a week for 60 days, recording adherence in a diary; group 2: performs the same PEP schedule and also records adherence in a diary.
Follow-up visits take place at 2, 4, and 6 months after the first injection, with additional telephone check-ins at 1 and 3 months.
Detailed description
This post-market, multicenter, randomized, controlled, open-label clinical investigation aims to evaluate the performance and safety of three intra-articular (IA) injections of HyalganBio® combined with a Physical Exercise Program (PEP) in patients with symptomatic glenohumeral osteoarthritis.
The primary objective is to assess the overall functional clinical improvement at 6 months after the first injection (V1), as measured by the Constant-Murley Score (CMS), comparing HyalganBio® + PEP versus PEP alone.
Eligible subjects are screened at Visit 0 (V0) after signing informed consent. If all inclusion and exclusion criteria are met, enrollment occurs and V0 may coincide with the baseline visit (V1). At V1, within 14 days from screening, participants are randomized 1:1. Group 1 receives three weekly IA injections of HyalganBio® (at V1, V2, V3) and is trained to perform a PEP three times per week for 60 days, recording adherence in a patient diary. Group 2 (control) is trained to perform the same PEP schedule and also reports adherence in a diary. Follow-up visits are planned at 2, 4, and 6 months after V1, with telephone contacts at 1 and 3 months.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HyalganBio® plus Physical Exercise Program (PEP) | Experimental | Device: Hyaluronic acid plus Physical Exercise Program (PEP)3 weekly intrarticular injections of HyalganBio® hyaluronic acid 20 mg/2 mL, supplied as a pre-filled syringe plus Physical exercise program (PEP) for 3 days a week for a period of 60 days. |
| Physical Exercise Program (PEP) | No intervention | –Physical exercise program (PEP) for 3 days a week for a period of 60 days. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female subjects aged ≥ 45 years and ≤ 85 years.
- Samilson Prieto Grade 1 to 3 of glenohumeral joint confirmed by a X-ray performed in the 6 months before the screening visit (or at the screening if not available in the past 6 months).
- Patient suffering from glenohumeral arthrosis with chronic shoulder pain. Chronic shoulder pain is defined as follows:
- Presence of pain on movement, in the target shoulder, measured by VAS with a score > 40 mm.
- VAS for pain in the contralateral shoulder of at least 10 mm less than the target joint.
Key exclusion criteria (19 listed)
- Presence, at clinical evaluation, of adhesive capsulitis.
- Presence of rotator cuff injury (Massive Rotator Cuff Tears).
- Signs, evident on X-ray of the shoulder, of recent fractures, intense loss of bone density and/or severe deformity.
- Diagnosis of major calcium pyrophosphate dihydrate crystal deposition (CPPD) or shoulder chondrocalcinosis disease.
- Presence of pathology of the cervical vertebrae (capable of altering the clinical evaluation) which, in the three months preceding the screening visit, was symptomatic and required active treatment.
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 |
|---|---|---|
| Hyaluronic acid plus Physical Exercise Program (PEP)3 weekly intrarticular injections of HyalganBio® in a concentration of HA 2% (20 mg/2 mL) and PEP. | Device | HyalganBio® plus Physical Exercise Program (PEP) |
Primary outcome
Performance of three intra-articular (IA) injections of HyalganBio® plus Physical Exercise Program (PEP), in terms of overall clinical functional assessment on movement.
Time frame: 6 months from baseline.
The primary outcome of the investigation is the change of the total Constant Murley Score (CMS), a 100-point clinical scoring system. Total score evaluates four main components: A- Pain, B- Activities of daily living, C- Range of movement, D- Power each contributing a specific portion of the total score. Pain accounts for 15 points, daily activities for 20, range of motion for 40 and Power for 25.
8 secondary outcomes
Clinical functional assessment on movement.
Time frame: 2, 4 and 6 months from baseline.
Clinical functional assessment on movement.
Time frame: 2 and 4 months from baseline.
Pain reduction
Time frame: 2, 4 and 6 months from baseline.
Changes of physical function
Time frame: 2, 4 and 6 months compared to baseline.
Changes of patient's quality of life.
Time frame: 2, 4 and 6 months compared to baseline (V1).
Rescue medication consumption
Time frame: From baseline to the end of the study at 6 months.
Changes of Clinical Observer Global Assessment (COGA)
Time frame: 2, 4 and 6 months compared to baseline
Number of Participants with treatment-emergent adverse events.
Time frame: From baseline to the end of the study at 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic acid plus Physical Exercise Program (PEP) in people with Glenohumeral Osteoarthritis, run by Fidia Farmaceutici s.p.a. at 6 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 12 inclusion and 19 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: under way, not looking for participants, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
This study is still under way. Results are not available in the source record yet.
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?
Performance of three intra-articular (IA) injections of HyalganBio® plus Physical Exercise Program (PEP), in terms of overall clinical functional assessment on movement. (time frame: 6 months from baseline.). 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 16 Apr 2026.