Primary Knee Osteoarthritis Grade 3 - 4
Conditions
Keywords
Osteoarthritis, Lipocet
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.
Interventions
DIETARY_SUPPLEMENTLipocet® (food supplement)
1 sachet, 10 ml corresponding to 1500 mg of Cetylated fatty acids
DIETARY_SUPPLEMENTLipocet Placebo
Lipocet Placebo matching to Lipocet
Sponsors
NEA Clinical S.r.l.
Pharmanutra S.p.a.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Georgia
Outcome results
None listed