LIKEST Study: Lipocet® in Adults With Primary Knee Osteoarthritis Grade 3-4

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Double-blinded Multi-center Study of Efficacy and Safety of Lipocet® in Patients With Primary Knee Osteoarthritis Grade 3 - 4

Conditions
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Primary Knee Osteoarthritis Grade 3 - 4

Intervention / Treatment
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* Dietary Supplement: Lipocet® (food supplement)
* Dietary Supplement: Lipocet Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group (Lipocet®)<br>Participants received Lipocet® (food supplement) 1 sachet orally once a day for 60 days | Dietary Supplement: Lipocet® (food supplement)<br>* 1 sachet, 10 ml corresponding to 1500 mg of Cetylated fatty acids<br>|
| Placebo Comparator: Control group (Placebo)<br>Participants received Placebo 1 sachet orally once a day for 60 days | Dietary Supplement: Lipocet Placebo<br>* Lipocet Placebo matching to Lipocet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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. | From Baseline to Day 60 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number and % of patients with treatment-emergent adverse events | Incidence and severity of adverse events (AEs) that occurred during the treatment | From Baseline to Day 60 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Lipocet