Active — Not RecruitingNot Applicable

Performance and Safety of HyalganBio® Intra-Articular Injections as Add-On to Physical Exercise for Symptomatic Glenohumeral Osteoarthritis

Italy72 participantsStarted 2024-07-12

Plain-language 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. 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.

Who can participate

Age range45 Years – 85 Years

SexALL

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Inclusion criteria

✓. 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.
✓. 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\*.

Exclusion criteria

What they're measuring

Performance of three intra-articular (IA) injections of HyalganBio® plus Physical Exercise Program (PEP), in terms of overall clinical functional assessment on movement.

Timeframe: 6 months from baseline.

Trial details

NCT IDNCT07520708

SponsorFidia Farmaceutici s.p.a.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10

View on ClinicalTrials.gov More Glenohumeral Osteoarthritis trials