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

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

Study Overview

• Status: Completed
• Conditions: Primary Knee Osteoarthritis Grade 3 - 4
• Intervention / Treatment: Dietary supplement: Lipocet® (food supplement); Dietary supplement: Lipocet Placebo

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Georgia
  • Tbilisi, Georgia, 0160
    • LLC "Altra Vita"
  • Tbilisi, Georgia
    • JSC "Evex Hospitals" (Caraps Medline)
  • Tbilisi, Georgia
    • LLC "Unica"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pharmanutra S.p.a.
• Collaborators: NEA Clinical S.r.l.
• Investigators: Study Director: Maria Sole Rossato, Pharmanutra S.p.a.

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2022
• Primary Completion (Actual): March 6, 2023
• Study Completion (Actual): May 18, 2023

Study Registration Dates

• First Submitted: October 18, 2023
• First Submitted That Met QC Criteria: November 10, 2023
• First Posted (Estimated): November 16, 2023

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 10, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Osteoarthritis; Lipocet
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: LIP 02/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No