LIKEST Study: Lipocet® in Adults With Primary Knee Osteoarthritis Grade 3-4
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Pain on the Visual Analogue Scale (VAS scale) on day 60 [From Baseline to 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).
- Change From Baseline in Knee Range Of Motion (ROM) on day 60 [From Baseline to Day 60]
Flexion, Extension, External rotation, Internal rotation were measured in degrees. Change = (Day 60 - Baseline Result).
- Change From Baseline in WOMAC Total score (Western Ontario and MCMaster Osteoarthritis Index Questionnaire) on day 60 [From Baseline to 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.
Secondary Outcome Measures
- The number and % of patients with treatment-emergent adverse events [From Baseline to Day 60]
Incidence and severity of adverse events (AEs) that occurred during the treatment
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Signed Patient Information Sheet and Informed Consent Form
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Patients with primary osteoarthritis classified according to ACR/EULAR criteria
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Men or women aged ≥ 40 and ≤80 years
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A disease severity grade 3 or 4 according to the Kellgren-Lawrence classification:
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grade 0 (none): definite absence of x-ray changes of osteoarthritis
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grade 1 (doubtful): doubtful joint space narrowing and possible osteophytic lipping
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grade 2 (minimal): definite osteophytes and possible joint space narrowing
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grade 3 (moderate): moderate multiple osteophytes, definite narrowing of joint space and some sclerosis and possible deformity of bone ends
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grade 4 (severe): large osteophytes, marked narrowing of joint space, severe sclerosis and definite deformity of bone ends
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Patients who are candidates for knee replacements can be included (this criterion is not mandatory)
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Patients who mark the pain ≥ 4 cm on a VAS
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Patients who are willing or able to follow doctor's instructions
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Patients not participating in other clinical trials within 30 days before the screening
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Patients who have received sufficient explanation for this clinical trial and agreed to participate
Exclusion Criteria:
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BMI > 32
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Systemic inflammatory diseases (e.g. fibromyalgia, etc.)
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Progressive serious medical conditions (such as cancer, AIDS or end-stage renal disease)
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Patients with major infections in the observation period
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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)
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Liver dysfunction (serum alanine or aspartate transaminase concentrations more than 1.5 times the upper limit of normal
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | LLC "Altra Vita" | Tbilisi | Georgia | 0160 | |
| 2 | JSC "Evex Hospitals" (Caraps Medline) | Tbilisi | Georgia | ||
| 3 | LLC "Unica" | Tbilisi | Georgia |
Sponsors and Collaborators
- Pharmanutra S.p.a.
- NEA Clinical S.r.l.
Investigators
- Study Director: Maria Sole Rossato, Pharmanutra S.p.a.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LIP 02/22