Status:
COMPLETED
LIKEST Study: Lipocet® in Adults With Primary Knee Osteoarthritis Grade 3-4
Lead Sponsor:
Pharmanutra S.p.a.
Collaborating Sponsors:
NEA Clinical S.r.l.
Conditions:
Primary Knee Osteoarthritis Grade 3 - 4
Eligibility:
All Genders
40-80 years
Phase:
NA
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 incl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 18 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06134115
Start Date
August 19 2022
End Date
May 18 2023
Last Update
November 18 2023
Active Locations (3)
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1
LLC "Altra Vita"
Tbilisi, Georgia, 0160
2
JSC "Evex Hospitals" (Caraps Medline)
Tbilisi, Georgia
3
LLC "Unica"
Tbilisi, Georgia