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

NCT ID: NCT06134115

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-19
• Study Completion Date: 2023-05-18

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.

Conditions

Primary Knee Osteoarthritis Grade 3 - 4

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment group (Lipocet®)

Participants received Lipocet® (food supplement) 1 sachet orally once a day for 60 days

Group Type: EXPERIMENTAL

Lipocet® (food supplement)

Intervention Type: DIETARY_SUPPLEMENT

1 sachet, 10 ml corresponding to 1500 mg of Cetylated fatty acids

Control group (Placebo)

Participants received Placebo 1 sachet orally once a day for 60 days

Group Type: PLACEBO_COMPARATOR

Lipocet Placebo

Intervention Type: DIETARY_SUPPLEMENT

Lipocet Placebo matching to Lipocet

Interventions

Lipocet® (food supplement)

1 sachet, 10 ml corresponding to 1500 mg of Cetylated fatty acids

Intervention Type: DIETARY_SUPPLEMENT

Lipocet Placebo

Lipocet Placebo matching to Lipocet

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NEA Clinical S.r.l.

UNKNOWN

Sponsor Role: collaborator

Pharmanutra S.p.a.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Sole Rossato

Role: STUDY_DIRECTOR

Pharmanutra S.p.a.

Locations

LLC "Altra Vita"

Tbilisi, , Georgia

JSC "Evex Hospitals" (Caraps Medline)

Tbilisi, , Georgia

LLC "Unica"

Tbilisi, , Georgia

Countries

Georgia

Other Identifiers

LIP 02/22

Identifier Type: -

Identifier Source: org_study_id