Clinical trial NCT06134115: LIKEST Study: Lipocet® in Adults With Primary Knee Osteoarthritis Grade 3-4
Official title: Randomized Double-blinded Multi-center Study of Efficacy and Safety of Lipocet® in Patients With Primary Knee Osteoarthritis Grade 3 - 4
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Knee Osteoarthritis Grade 3 - 4
Keywords: Osteoarthritis
Lipocet
Lead sponsor: Pharmanutra S.p.a.
Sponsor class: INDUSTRY
Collaborators: name: NEA Clinical S.r.l.
First posted: 2023-11-18
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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.

Eligibility criteria: Inclusion Criteria:

1. Signed Patient Information Sheet and Informed Consent Form
2. Patients with primary osteoarthritis classified according to ACR/EULAR criteria
3. Men or women aged ≥ 40 and ≤80 years
4. 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
   * 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
5. Patients who are candidates for knee replacements can be included (this criterion is not mandatory)
6. Patients who mark the pain ≥ 4 cm on a VAS
7. Patients who are willing or able to follow doctor's instructions
8. Patients not participating in other clinical trials within 30 days before the screening
9. Patients who have received sufficient explanation for this clinical trial and agreed to participate

Exclusion Criteria:

1. BMI \> 32
2. Systemic inflammatory diseases (e.g. fibromyalgia, etc.)
3. Progressive serious medical conditions (such as cancer, AIDS or end-stage renal disease)
4. Patients with major infections in the observation period
5. 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)
6. Liver dysfunction (serum alanine or aspartate transaminase concentrations more than 1.5 times the upper limit of normal

Primary outcomes:
measure: Change From Baseline in Pain on the Visual Analogue Scale (VAS scale) on day 60
timeFrame: From Baseline to Day 60
measure: Change From Baseline in Knee Range Of Motion (ROM) on day 60
timeFrame: From Baseline to Day 60
measure: Change From Baseline in WOMAC Total score (Western Ontario and MCMaster Osteoarthritis Index Questionnaire) on day 60
timeFrame: From Baseline to Day 60
Secondary outcomes:
measure: The number and % of patients with treatment-emergent adverse events
timeFrame: From Baseline to Day 60
Other outcomes:
Locations:
city: Tbilisi
country: Georgia
facility: LLC "Altra Vita"
city: Tbilisi
country: Georgia
facility: JSC "Evex Hospitals" (Caraps Medline)
city: Tbilisi
country: Georgia
facility: LLC "Unica"
Study officials:
affiliation: Pharmanutra S.p.a.
name: Maria Sole Rossato
role: STUDY_DIRECTOR
References: