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

NCT06134115 | Completed

• 1 other identifier: LIP 02/22
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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

Conditions

Primary Knee Osteoarthritis Grade 3 - 4

Keywords

Osteoarthritis; Lipocet

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• The number and % of patients with treatment-emergent adverse events

  From Baseline to Day 60

Study Arms (2)

Treatment group (Lipocet®)

EXPERIMENTAL

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

Dietary Supplement: Lipocet® (food supplement)

Control group (Placebo)

PLACEBO COMPARATOR

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

Dietary Supplement: Lipocet Placebo

Interventions

Lipocet® (food supplement) DIETARY_SUPPLEMENT

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

Treatment group (Lipocet®)

Lipocet Placebo DIETARY_SUPPLEMENT

Lipocet Placebo matching to Lipocet

Control group (Placebo)

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pharmanutra S.p.a.: lead
• NEA Clinical S.r.l.: collaborator

Study Sites (3)

LLC "Altra Vita"

Tbilisi, 0160, Georgia

Location

JSC "Evex Hospitals" (Caraps Medline)

Tbilisi, Georgia

Location

LLC "Unica"

Tbilisi, Georgia

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Maria Sole Rossato

  Pharmanutra S.p.a.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: November 18, 2023
• Study Start: August 19, 2022
• Primary Completion: March 6, 2023
• Study Completion: May 18, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GE (3)