Primary Knee Osteoarthritis Grade 3 - 4NCT06134115
LIKEST Study: Lipocet® in Adults With Primary Knee Osteoarthritis Grade 3-4
A study testing Lipocet® (food supplement) in people with Primary Knee Osteoarthritis Grade 3 - 4, run by Pharmanutra S.p.a. at 3 sites in Georgia.
Trial summary
The purpose of this study is to assess the safety, tolerability and efficacy of Lipocet® (food supplement) in patients with primary knee osteoarthritis grade 3 - 4 Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Primary Knee Osteoarthritis Grade 3 - 4
- What is being tested?
- Lipocet® (food supplement)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 3 sitesGeorgia
- Study dates
- 19 Aug 2022to 18 May 2023
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Patient Information Sheet and Informed Consent Form
- Patients with primary osteoarthritis classified according to ACR/EULAR criteria
- Men or women aged ≥ 40 and ≤80 years
- A disease severity grade 3 or 4 according to the Kellgren-Lawrence classification:
- grade 0 (none): definite absence of x-ray changes of osteoarthritis
- grade 1 (doubtful): doubtful joint space narrowing and possible osteophytic lipping
Show all 14Show fewer
- grade 2 (minimal): definite osteophytes and possible joint space narrowing
- grade 3 (moderate): moderate multiple osteophytes, definite narrowing of joint space and some sclerosis and possible deformity of bone ends
- grade 4 (severe): large osteophytes, marked narrowing of joint space, severe sclerosis and definite deformity of bone ends
- Patients who are candidates for knee replacements can be included (this criterion is not mandatory)
- Patients who mark the pain ≥ 4 cm on a VAS
- Patients who are willing or able to follow doctor's instructions
- Patients not participating in other clinical trials within 30 days before the screening
- Patients who have received sufficient explanation for this clinical trial and agreed to participate
Who cannot join
- BMI > 32
- Systemic inflammatory diseases (e.g. fibromyalgia, etc.)
- Progressive serious medical conditions (such as cancer, AIDS or end-stage renal disease)
- Patients with major infections in the observation period
- Renal diseases (serum creatinine concentration more than 1.2 times the upper limit of the normal range according to the central laboratory definition reference values)
- Liver dysfunction (serum alanine or aspartate transaminase concentrations more than 1.5 times the upper limit of normal
Trial locations and contacts
3 sites in 1 country.
Georgia3 sites
LLC "Altra Vita"
Tbilisi, 0160
JSC "Evex Hospitals" (Caraps Medline)
Tbilisi
LLC "Unica"
Tbilisi
About this study
Official title: Randomized Double-blinded Multi-center Study of Efficacy and Safety of Lipocet® in Patients With Primary Knee Osteoarthritis Grade 3 - 4
The purpose of this study is to assess the safety, tolerability and efficacy of Lipocet® (food supplement) in patients with primary knee osteoarthritis grade 3 - 4
Read the detailed description
After being informed about the study, all patients giving written informed consent will undergo no more than a 1-week screening period to determine eligibility for study entry. Patients that meet inclusion criteria and do not have exclusion criteria will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to Lipocet ® (once a day, 10 ml corresponding to 1500 mg of Cetylated fatty acids) or placebo (once a day, 10 ml) during 60 days of treatment.
- Conditions
- Primary Knee Osteoarthritis Grade 3 - 4
- Being tested
- Lipocet® (food supplement), Lipocet Placebo
- Keywords
- Osteoarthritis, Lipocet
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipocet® (food supplement)Dietary supplement
1 sachet, 10 ml corresponding to 1500 mg of Cetylated fatty acids
Lipocet PlaceboDietary supplement
Lipocet Placebo matching to Lipocet
| Study group | Role | What they receive |
|---|---|---|
| Treatment group (Lipocet®) | Experimental | Participants received Lipocet® (food supplement) 1 sachet orally once a day for 60 days Receives: Dietary Supplement: Lipocet® (food supplement) |
| Control group (Placebo) | Placebo comparator | Participants received Placebo 1 sachet orally once a day for 60 days Receives: Dietary Supplement: Lipocet Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Pain on the Visual Analogue Scale (VAS scale) on day 60
Visual analogue scale (VAS) is a validated questionnaire assessing pain intensity during 60 days of treatment. Possible scores range from 0 cm (no pain) to 10 cm (Pain as bad as it could be). Change = (Day 60 - Baseline Score).
Measured: From Baseline to Day 60
Change From Baseline in Knee Range Of Motion (ROM) on day 60
Flexion, Extension, External rotation, Internal rotation were measured in degrees. Change = (Day 60 - Baseline Result).
Measured: From Baseline to Day 60
Change From Baseline in WOMAC Total score (Western Ontario and MCMaster Osteoarthritis Index Questionnaire) on day 60
WOMAC is a validated questionnaire assessing functionality during 60 days of treatment. Possible scores result from 0 to 96 score. Change = (Day 60 - Baseline Score). The WOMAC consists of three subscales: pain (five questions), stiffness (two questions), and physical function (17 questions). The subscale scores can vary, with pain ranging from 0 to 20 points; stiffness, 0 to 8 points; and physical function, 0 to 68 points. Higher scores represent worse pain, stiffness, and functional limitations.
Measured: From Baseline to Day 60
Secondary outcomes (1)
The number and % of patients with treatment-emergent adverse events
Incidence and severity of adverse events (AEs) that occurred during the treatment
Measured: From Baseline to Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start19 Aug 2022
- Primary completion6 Mar 2023
- Study completion18 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Knee Osteoarthritis Grade 3 - 4Studies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmanutra S.p.a.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NEA Clinical S.r.l.
- Responsible party
- Sponsor
- Investigators
- Maria Sole Rossato, Study director, Pharmanutra S.p.a.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06134115
- Sponsor's protocol ID
- LIP 02/22
- Status last verified
- Nov 2023
- First submitted
- 18 Oct 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-blinded Multi-center Study of Efficacy and Safety of Lipocet® in Patients With Primary Knee Osteoarthritis Grade 3 - 4
- ClinicalTrials.gov ID
- NCT06134115
- Acronym / sponsor ID
- LIP 02/22
- Conditions
- Primary Knee Osteoarthritis Grade 3 - 4
- Keywords
- Osteoarthritis, Lipocet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pharmanutra S.p.a.Industry (pharma, biotech, devices)
- Collaborators
- NEA Clinical S.r.l.
- Study start
- 19 Aug 2022 (actual)
- Primary completion
- 6 Mar 2023 (actual)
- Study completion
- 18 May 2023 (actual)
- First posted
- 18 Nov 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.
The purpose of this study is to assess the safety, tolerability and efficacy of Lipocet® (food supplement) in patients with primary knee osteoarthritis grade 3 - 4
Detailed description
After being informed about the study, all patients giving written informed consent will undergo no more than a 1-week screening period to determine eligibility for study entry. Patients that meet inclusion criteria and do not have exclusion criteria will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to Lipocet ® (once a day, 10 ml corresponding to 1500 mg of Cetylated fatty acids) or placebo (once a day, 10 ml) during 60 days of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group (Lipocet®) | Experimental | Dietary Supplement: Lipocet® (food supplement)Participants received Lipocet® (food supplement) 1 sachet orally once a day for 60 days |
| Control group (Placebo) | Placebo comparator | Dietary Supplement: Lipocet PlaceboParticipants received Placebo 1 sachet orally once a day for 60 days |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Signed Patient Information Sheet and Informed Consent Form
- Patients with primary osteoarthritis classified according to ACR/EULAR criteria
- Men or women aged ≥ 40 and ≤80 years
- A disease severity grade 3 or 4 according to the Kellgren-Lawrence classification:
- Patients who are candidates for knee replacements can be included (this criterion is not mandatory)
Key exclusion criteria (6 listed)
- BMI > 32
- Systemic inflammatory diseases (e.g. fibromyalgia, etc.)
- Progressive serious medical conditions (such as cancer, AIDS or end-stage renal disease)
- Patients with major infections in the observation period
- Renal diseases (serum creatinine concentration more than 1.2 times the upper limit of the normal range according to the central laboratory definition reference values)
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 |
|---|---|---|
| Lipocet® (food supplement)1 sachet, 10 ml corresponding to 1500 mg of Cetylated fatty acids | Dietary supplement | Treatment group (Lipocet®) |
| Lipocet PlaceboLipocet Placebo matching to Lipocet | Dietary supplement | Control group (Placebo) |
Primary outcome
Change From Baseline in Pain on the Visual Analogue Scale (VAS scale) on day 60
Time frame: From Baseline to Day 60
Visual analogue scale (VAS) is a validated questionnaire assessing pain intensity during 60 days of treatment. Possible scores range from 0 cm (no pain) to 10 cm (Pain as bad as it could be). Change = (Day 60 - Baseline Score).
Change From Baseline in Knee Range Of Motion (ROM) on day 60
Time frame: From Baseline to Day 60
Flexion, Extension, External rotation, Internal rotation were measured in degrees. Change = (Day 60 - Baseline Result).
Change From Baseline in WOMAC Total score (Western Ontario and MCMaster Osteoarthritis Index Questionnaire) on day 60
Time frame: From Baseline to Day 60
WOMAC is a validated questionnaire assessing functionality during 60 days of treatment. Possible scores result from 0 to 96 score. Change = (Day 60 - Baseline Score). The WOMAC consists of three subscales: pain (five questions), stiffness (two questions), and physical function (17 questions). The subscale scores can vary, with pain ranging from 0 to 20 points; stiffness, 0 to 8 points; and physical function, 0 to 68 points. Higher scores represent worse pain, stiffness, and functional limitations.
1 secondary outcome
The number and % of patients with treatment-emergent adverse events
Time frame: From Baseline to Day 60
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 18 Nov 2023.
- Individual participant dataSharing planned: No
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.
Maria Sole Rossato study director
Pharmanutra S.p.a.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lipocet® (food supplement) in people with Primary Knee Osteoarthritis Grade 3 - 4, run by Pharmanutra S.p.a. at 3 sites in Georgia.
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 6 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 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Georgia. 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. Some participants in this study may receive a placebo. 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?
Change From Baseline in Pain on the Visual Analogue Scale (VAS scale) on day 60 (time frame: From Baseline to Day 60). The study lists 3 primary outcomes in all. 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 18 Nov 2023.