Osteoarthritis of KneePhase 4NCT05936762
Clinical Efficacy and Safety of NEOIAL HC for Intra-articular Use in the Treatment of Severe Knee Osteoarthritis
A Phase 4 study testing Neoial HC in people with Osteoarthritis of Knee, run by Nextrasearch S.r.l.s. at 1 site in Italy.
Trial summary
Osteoarthritis (OA) is one of the most frequent causes of pain and disability in adults. According to the Osteoarthritis Research Society International (OARSI), at least 40% of people over the age of 65 suffer from symptomatic osteoarthritis of the hip or knee. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis of Knee
- What is being tested?
- Neoial HC
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 31 Aug 2021to 9 Aug 2022
- Phase
- Phase 4
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age
- Knee OA
- VAS > 3
- Kellegren radiographic stage 3-4
Who cannot join
- presence of joint effusion,
- VAS score <3 according to the American College of Rheumatology Criteria
- neoplasms,
- haematological diseases,
- specific rheumatological pathologies,
- bleeding disorders, local infections,
Show all 10Show fewer
- refusal or non-compliance of the patient,
- candidacy for knee joint replacement or any intra-articular injection during the previous year,
- addiction to opioid drugs,
- recent heart attack or stroke.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Efficacy and Safety of NEOIAL HC (Hyaluronic Acid + Collagen) for Intra-articular Use in the Treatment of Severe Knee Osteoarthritis
Osteoarthritis (OA) is one of the most frequent causes of pain and disability in adults. According to the Osteoarthritis Research Society International (OARSI), at least 40% of people over the age of 65 suffer from symptomatic osteoarthritis of the hip or knee. Knee osteoarthritis (OA) is the eleventh leading cause of years lived with disability according to the World Health Organization.
The guidelines show that treatment with intra-articular injections of hyaluronic acid (HA) leads to a slow, prolonged pain relief (up to six months after the first injection); On the other hand, there is little evidence in the literature about the intra-articular use of isolated collagen or in combination with hyaluronic acid in the treatment of knee osteoarthritis.
The present study showed a clinically good safety profile and provided preliminary evidence of the efficacy of NEOIAL HC for the treatment of symptomatic knee OA
- Conditions
- Osteoarthritis of Knee
- Being tested
- Neoial HC
- Keywords
- Osteoarthritis, knee, hyaluronic, collagen, neoial, gonarthrosis
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoial HCDevice
Patients with severe knee osteoarthritis were enrolled in the clinical study and treated with 3 injections of 40 mg NEOIAL HC (HA sodium salt at 2% with two molecular weights 20% with pm at 400 kD and 80% between 1200 and 1500 kD t + collagen) at a distance of 1 week from each other, followed by a fourth infiltration of the same product at a distance of 1 month from the third.Patients were followed up with baseline clinical evaluation, reporting of adverse events after each single infiltration and subsequently at the end of treatment, 3, 6 months follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Neoial | Experimental | Treatment with the MD Receives: Device: Neoial HC |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS score
The primary objective in the study was to evaluate the mean changes from baseline at Month 3 in VAS Pain Subscale Score
Measured: 6 months
Secondary outcomes (3)
Knee Injury and Osteoarthritis Outcome Score (KOOS)
The KOOS is self-administered and assesses 5 domains: pain, symptoms, activities of daily living (ADL), sport and recreation function, and knee-related quality of life. This scale is used to evaluate knee function in terms of activities of daily living (ADL).
Measured: 6 months
Lequesne
measure the severity for osteoarthritis for the knee (ISK). This can be used to assess the effectiveness of therapeutic interventions
Measured: 6 months
Western Ontario McMaster Universities (WOMAC®) VA3.1
self-administered, patient-centered health status questionnaires allowing a thorough evaluation of pain, stiffness, and knee function (24 questions through three subscales)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start31 Aug 2021
- Primary completion9 Aug 2022
- Study completion9 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Of the 36 screened patients, 15 had to be included and treated patients (15 as planned per-protocol). Of these, 14 patients completed the study and attended the visit at Month 6 . Since all patients were treated , the Full Analysis Set (FAS, all randomized and treated patients) was identical to the Safety Set (all treated patients). The mean age at enrollment was 71±7 years (range 54-80;median 73), and 12 of patients were women (85.7%) and 2 male (14.3%) . The mean BMI were26.6±3.4 (range 21-30;median 28.5) . Overall patients had knee OA with a Kellgren-Lawrence grade II and III (50/50).
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nextrasearch S.r.l.s.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roberto Buda, Prof, Principal investigator, Ospedale Santa Annunziata di Chieti
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05936762
- Sponsor's protocol ID
- NeoialHC
- Status last verified
- Jun 2023
- First submitted
- 9 Jun 2023
- Last updated
- 10 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy and Safety of NEOIAL HC (Hyaluronic Acid + Collagen) for Intra-articular Use in the Treatment of Severe Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05936762
- Acronym / sponsor ID
- NeoialHC
- Conditions
- Osteoarthritis of Knee
- Keywords
- Osteoarthritis, knee, hyaluronic, collagen, neoial, gonarthrosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Nextrasearch S.r.l.s.University, hospital or other
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 9 Aug 2022 (actual)
- Study completion
- 9 Aug 2022 (actual)
- First posted
- 10 Jul 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.
Osteoarthritis (OA) is one of the most frequent causes of pain and disability in adults. According to the Osteoarthritis Research Society International (OARSI), at least 40% of people over the age of 65 suffer from symptomatic osteoarthritis of the hip or knee. Knee osteoarthritis (OA) is the eleventh leading cause of years lived with disability according to the World Health Organization.
The guidelines show that treatment with intra-articular injections of hyaluronic acid (HA) leads to a slow, prolonged pain relief (up to six months after the first injection); On the other hand, there is little evidence in the literature about the intra-articular use of isolated collagen or in combination with hyaluronic acid in the treatment of knee osteoarthritis.
The present study showed a clinically good safety profile and provided preliminary evidence of the efficacy of NEOIAL HC for the treatment of symptomatic knee OA
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Of the 36 screened patients, 15 had to be included and treated patients (15 as planned per-protocol). Of these, 14 patients completed the study and attended the visit at Month 6 . Since all patients were treated , the Full Analysis Set (FAS, all randomized and treated patients) was identical to the Safety Set (all treated patients). The mean age at enrollment was 71±7 years (range 54-80;median 73), and 12 of patients were women (85.7%) and 2 male (14.3%) . The mean BMI were26.6±3.4 (range 21-30;median 28.5) . Overall patients had knee OA with a Kellgren-Lawrence grade II and III (50/50).
| Arm | Type | Receives |
|---|---|---|
| Neoial | Experimental | Device: Neoial HCTreatment with the MD |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age
- Knee OA
- VAS > 3
- Kellegren radiographic stage 3-4
Key exclusion criteria (10 listed)
- presence of joint effusion,
- VAS score <3 according to the American College of Rheumatology Criteria
- neoplasms,
- haematological diseases,
- specific rheumatological pathologies,
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 |
|---|---|---|
| Neoial HCPatients with severe knee osteoarthritis were enrolled in the clinical study and treated with 3 injections of 40 mg NEOIAL HC (HA sodium salt at 2% with two molecular weights 20% with pm at 400 kD and 80% between 1200 and 1500 kD t + collagen) at a distance of 1 week from each other, followed by a fourth infiltration of the same product at a distance of 1 month from the third.Patients were followed up with baseline clinical evaluation, reporting of adverse events after each single infiltration and subsequently at the end of treatment, 3, 6 months follow-up. | Device | Neoial |
Primary outcome
VAS score
Time frame: 6 months
The primary objective in the study was to evaluate the mean changes from baseline at Month 3 in VAS Pain Subscale Score
3 secondary outcomes
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 6 months
Lequesne
Time frame: 6 months
Western Ontario McMaster Universities (WOMAC®) VA3.1
Time frame: 6 months
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 10 Jul 2023.
- Individual participant dataSharing planned: Yes
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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.
Roberto Buda, Prof principal investigator
Ospedale Santa Annunziata di Chieti
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Neoial HC in people with Osteoarthritis of Knee, run by Nextrasearch S.r.l.s. 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 4 inclusion and 10 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 10 Jul 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
VAS score (time frame: 6 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 10 Jul 2023.