NCT07680101Not yet recruiting
Intra-Articular Adelmidrol 2%/Hyaluronic Acid 1% With or Without m/umPEA, in Knee Pain Due to Joint Degeneration.
Efficacy of Intra-articular Treatment With Adelmidrol 2% / Hyaluronic Acid 1%, With or Without m/umPEA, in Knee Pain Due to Joint Degeneration: a Bicentric, Prospective, Randomized Study.
Source: ClinicalTrials.gov · Last updated 2 Jul 2026
Brief summary (registry, in English)
Degenerative knee joint diseases are characterized by chronic pain, inflammation, and functional impairment. In these conditions, mast cell density in the synovial membrane is increased, resulting in an excessive release of biological mediators involved in key mechanisms of neuroinflammation and in hyaluronic acid depolymerisation. Adelmidrol acts as a preventive antioxidant due to its radical scavenging activity, thus protecting hyaluronic acid from oxidative degradation and reducing mast cell degranulation. Furthermore, a reduction in endogenous Palmitoylethanolamide (PEA) levels also contributes to joint neuroinflammation and disease progression; therefore, its exogenous supplementation may represent a valuable supportive strategy. The objective of this clinical investigation is to compare the efficacy of intra-articular adelmidrol/hyaluronic acid treatment alone versus the same intra-articular treatment combined with oral micronized /ultramicronized PEA in patients with knee joint degeneration due to osteoarthritis or rheumatoid arthritis.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 25 Jun 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Universita di Verona
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT07680101
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 1 Jun 2026 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Intra-articular knee injections within 3 months prior to enrollment
- Knee surgery within 6 months prior to enrollment
- Systemic treatment with chondroprotectors within 1 month prior to enrollment
- Systemic corticosteroid treatment within 1 month prior to enrollment
- Chronic Non-Steroidal Anti-Inflammatory Drugs (NSAID) therapy
Other illness
- Severe progressive systemic diseases
- Known hypersensitivity to study treatments
Other
- Contraindications to intra-articular knee injections
- Pregnancy or breastfeeding
Who the study is looking for
- Age ≥ 40 years
- Male or female
- Diagnosis of unilateral or bilateral knee joint degeneration due to osteoarthritis or rheumatoid arthritis, Kellgren-Lawrence grade II-III
- Duration of knee pain ≥ 6 months
- Baseline WOMAC score ≥ 20
- Drug therapy stabilized for at least 3 months in the case of patients with rheumatoid arthritis
- Naïve to palmitoylethanolamide treatment
- Signed informed consent
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Azienda Ospedaliera Universitaria Integrata Verona Coordinator of this site? Confirm its status | Verona | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.