Knee OsteoarthristisCETI-KNEENCT07745387
Effect of a Topical Cetylated Fatty Acid Cream on Pain Relief in Patients With Knee Osteoarthritis
A study testing Cetilar® Cream in people with Knee Osteoarthristis, run by Pharmanutra S.p.a. at 4 sites in Georgia.
Trial summary
This multicenter, randomized, double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of Cetilar® cream in adults with osteoarthritis-related knee pain. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Knee Osteoarthristis
- What is being tested?
- Cetilar® Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 4 sitesGeorgia
- Study dates
- 24 Jun 2024to 20 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated written informed consent.
- Male or female participants aged 40 to 75 years.
- Diagnosis of idiopathic knee osteoarthritis according to American College of Rheumatology (ACR) criteria.
- Compliance of the disease course with the following criteria:
- symptoms for at least 6 months prior to screening
- index knee pain for at least 15 days of the preceding month (periarticular knee pain due to OA and not due to other conditions such as bursitis, tendinitis, etc.);
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- walking arthritis pain required the periodic use of acetaminophen or NSAIDs (topical or oral products) on demand.
- Presence of X-ray (taken no more than 3 months before baseline) showing evidence of osteoarthritis with Kellgren-Lawrence grade 2-3 in the index knee.
- The average walking pain intensity during previous 24 hours in the index knee should be ≥40 mm on VAS (100 mm) at screening and prior to planned start of treatment.
- In case the patient uses helper (cane) during the walking, he/she should have been using it routinely during at least previous 6 months. The same helper should be used during the study.
- Patients who can use cream for 28-32 consecutive days (through the trial).
- Women of childbearing potential must agree to use an acceptable barrier method of contraception during study participation.
Who cannot join
- Intolerance or allergic reactions to any component of the study therapy. Severe hypersensitivity reactions to any drugs in past medical history.
- Usage of NSAIDs within 3 days or steroids within 7 days prior to planned start of treatment. In case when drug elimination exceeds defined period, it should be cancelled for the period of at least 5 half-lives.
- Usage of intra-articular hyaluronic acid injections for period less than 3 months prior to the planned start of treatment.
- Usage of DMOADs (disease-modifying osteoarthritis drugs) for period less than 3 months prior to the planned start of treatment.
- Open skin lesions or dermatological conditions at the site of cream application.
- Data on another etiology of the index knee joint lesion: gout, chondrocalcinosis, septic arthritis, infectious arthritis, Paget disease, aseptic osteonecrosis, seronegative spondyloarthropathies (psoriatic arthritis, ankylosing spondyloarthritis), metabolic (ochronosis, hemochromatosis) or autoimmune diseases (rheumatoid arthritis, systemic lupus erythematosus).
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- Surgery or major trauma of the index knee within the previous 12 months.
- Presence of pain that could interfere with the assessment of knee pain (e.g. pain in any other part of the target lower extremity, pain radiating to the knee).
- BMI≥35 kg/m2.
- History of clinically relevant concomitant pathology at exacerbation or decompensation stage, specifically: verified heart failure (III-IV NYHA functional class), thrombosis, hemophilia and other coagulation disorders, decompensated diabetes mellitus type 2, uncontrollable seizures or any other pathology which, according to the investigator's opinion, prevents from the subject enrollment for safety reasons or may affect the study result.
- Liver damage (e.g. acute hepatitis, active chronic hepatitis, cirrhosis, hepatic encephalopathy) or hepatic enzyme levels (AST and/or ALT) >2 UNL (upper normal level).
- History of expressed renal failure (creatinine clearance < 30 mL/min) or blood creatinine and/or urea level > 1,5 UNL (upper normal level).
- Uncontrollable hypertension: systolic blood pressure > 180 mm Hg and/or diastolic blood pressure > 110 mm Hg.
- Pregnant or breast-feeding women.
- Necessity to take any drugs and/or dietary supplements from the list of treatments prohibited by the protocol (see Section 7.6) during the period of the study.
- Consumption of more than 5 portions of alcoholic drinks per week or alcohol addiction, drug addiction or drug abuse in the past. One portion of an alcoholic drink means 360 ml of beer, 120 ml of wine or 30 ml of a strong alcoholic drink.
- The patient's supposed low treatment compliance or inability to fulfill the procedures and observe the restrictions prescribed by the study protocol (e.g. due to mental disorders).
- Active cancer in medical history.
- Hepatitis B, hepatitis C or HIV in medical history.
- Participation in any other clinical study during 4 weeks or 5 half-life periods (in case of the study of an experimental drug) (depending on which is longer) before the randomization.
- Subjects qualified by law as legally incapable or under custody.
- Employees of the study site, personnel of Sponsor's company or involved clinical research organization (CRO), investigator or his close family members.
- Any reasons that may (in the investigator's opinion) prevent the patient from following the protocol.
Trial locations and contacts
4 sites in 1 country.
Georgia4 sites
LLC "Altra Vita"
Tbilisi
LLC Institute of Clinical Cardiology
Tbilisi
LLC The First Medical Center
Tbilisi
LLC Unica
Tbilisi
About this study
Official title: Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Topical Cetylated Fatty Acid (CFA) Cream in Patients With Knee Osteoarthritis Pain
This multicenter, randomized, double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of Cetilar® cream in adults with osteoarthritis-related knee pain. The study will assess the effects of treatment on knee pain, physical function, use of rescue medication, quality of life, and safety outcomes.
Read the detailed description
Osteoarthritis of the knee is a common cause of pain, stiffness, and functional limitation. This multicenter, randomized, double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of Cetilar® cream, a topical formulation based on cetylated fatty acids, in patients with knee osteoarthritis pain. Approximately 156 participants will be randomized to receive Cetilar® cream or placebo cream applied twice daily for 30 days. Efficacy will be assessed through measures of pain intensity, physical function, patient-reported outcomes, and rescue medication use. Safety and tolerability will be evaluated through adverse event monitoring, clinical assessments, vital signs, and laboratory evaluations.
- Conditions
- Knee Osteoarthristis
- Being tested
- Cetilar® Cream, Placebo cream
- Keywords
- Knee Osteoarthritis, Knee Pain, Cetilar, Cetylated Fatty Acids, CFA
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cetilar® CreamOther
Topical cream containing cetylated fatty acids. The cream will be applied to the affected knee twice daily for 30 days.
Placebo creamOther
Matching placebo cream applied to the affected knee twice daily for 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Cetilar® Cream | Experimental | Participants will receive Cetilar® cream containing cetylated fatty acids, applied topically to the affected knee twice daily (every 12±1 hours) for 30 days. Receives: Other: Cetilar® Cream |
| Placebo Cream | Placebo comparator | Participants will receive matching placebo cream applied topically to the affected knee twice daily (every 12±1 hours) for 30 days. Receives: Other: Placebo cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Walking Arthritis Pain Intensity Score (VAS)
Difference in mean change from baseline in walking arthritis pain intensity measured using a 100-mm Visual Analogue Scale (VAS).
Measured: day 30
Secondary outcomes (7)
Change From Baseline in Walking Arthritis Pain Intensity Score (VAS)
Difference in mean change from baseline in walking arthritis pain intensity measured using a 100-mm Visual Analogue Scale (VAS).
Measured: day 14
Change From Baseline in Spontaneous Arthritis Pain Intensity Score (VAS)
Difference in mean change from baseline in spontaneous arthritis pain intensity measured using a 100-mm Visual Analogue Scale (VAS).
Measured: Days 14 and 30
Change From Baseline in WOMAC Stiffness Score
Difference in mean change from baseline in the WOMAC stiffness subscale score.
Measured: Days 14 and 30
Change From Baseline in WOMAC Physical Function Score
Difference in mean change from baseline in the WOMAC physical function subscale score.
Measured: Days 14 and 30
Change From Baseline in Lysholm Knee Scoring Scale (LKSS)
Difference in mean change from baseline in Lysholm Knee Scoring Scale score.
Measured: Days 14 and 30
Use of Rescue Medication
Use of acetaminophen rescue medication, including proportion of participants requiring rescue medication, total number of days of use, and total number of tablets taken.
Measured: Days 14 and 30
Patient Global Impression of Improvement (PGI-I)
Patient assessment of treatment efficacy using the 5-point Patient Global Impression of Improvement scale.
Measured: Days 14 and 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start24 Jun 2024
- Primary completion20 Nov 2024
- Study completion20 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthristisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmanutra S.p.a.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745387
- Sponsor's protocol ID
- CETI-KNEE
- Acronym
- CETI-KNEE
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Topical Cetylated Fatty Acid (CFA) Cream in Patients With Knee Osteoarthritis Pain
- ClinicalTrials.gov ID
- NCT07745387
- Acronym / sponsor ID
- CETI-KNEE / CETI-KNEE
- Conditions
- Knee Osteoarthristis
- Keywords
- Knee Osteoarthritis, Knee Pain, Cetilar, Cetylated Fatty Acids, CFA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Pharmanutra S.p.a.Industry (pharma, biotech, devices)
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- 20 Nov 2024 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 4 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicenter, randomized, double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of Cetilar® cream in adults with osteoarthritis-related knee pain. The study will assess the effects of treatment on knee pain, physical function, use of rescue medication, quality of life, and safety outcomes.
Detailed description
Osteoarthritis of the knee is a common cause of pain, stiffness, and functional limitation. This multicenter, randomized, double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of Cetilar® cream, a topical formulation based on cetylated fatty acids, in patients with knee osteoarthritis pain. Approximately 156 participants will be randomized to receive Cetilar® cream or placebo cream applied twice daily for 30 days. Efficacy will be assessed through measures of pain intensity, physical function, patient-reported outcomes, and rescue medication use. Safety and tolerability will be evaluated through adverse event monitoring, clinical assessments, vital signs, and laboratory evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cetilar® Cream | Experimental | Other: Cetilar® CreamParticipants will receive Cetilar® cream containing cetylated fatty acids, applied topically to the affected knee twice daily (every 12±1 hours) for 30 days. |
| Placebo Cream | Placebo comparator | Other: Placebo creamParticipants will receive matching placebo cream applied topically to the affected knee twice daily (every 12±1 hours) for 30 days. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Signed and dated written informed consent.
- Male or female participants aged 40 to 75 years.
- Diagnosis of idiopathic knee osteoarthritis according to American College of Rheumatology (ACR) criteria.
- Compliance of the disease course with the following criteria:
- Presence of X-ray (taken no more than 3 months before baseline) showing evidence of osteoarthritis with Kellgren-Lawrence grade 2-3 in the index knee.
Key exclusion criteria (23 listed)
- Intolerance or allergic reactions to any component of the study therapy. Severe hypersensitivity reactions to any drugs in past medical history.
- Usage of NSAIDs within 3 days or steroids within 7 days prior to planned start of treatment. In case when drug elimination exceeds defined period, it should be cancelled for the period of at least 5 half-lives.
- Usage of intra-articular hyaluronic acid injections for period less than 3 months prior to the planned start of treatment.
- Usage of DMOADs (disease-modifying osteoarthritis drugs) for period less than 3 months prior to the planned start of treatment.
- Open skin lesions or dermatological conditions at the site of cream application.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cetilar® CreamTopical cream containing cetylated fatty acids. The cream will be applied to the affected knee twice daily for 30 days. | Other | Cetilar® Cream |
| Placebo creamMatching placebo cream applied to the affected knee twice daily for 30 days. | Other | Placebo Cream |
Primary outcome
Change from Baseline in Walking Arthritis Pain Intensity Score (VAS)
Time frame: day 30
Difference in mean change from baseline in walking arthritis pain intensity measured using a 100-mm Visual Analogue Scale (VAS).
7 secondary outcomes
Change From Baseline in Walking Arthritis Pain Intensity Score (VAS)
Time frame: day 14
Change From Baseline in Spontaneous Arthritis Pain Intensity Score (VAS)
Time frame: Days 14 and 30
Change From Baseline in WOMAC Stiffness Score
Time frame: Days 14 and 30
Change From Baseline in WOMAC Physical Function Score
Time frame: Days 14 and 30
Change From Baseline in Lysholm Knee Scoring Scale (LKSS)
Time frame: Days 14 and 30
Use of Rescue Medication
Time frame: Days 14 and 30
Patient Global Impression of Improvement (PGI-I)
Time frame: Days 14 and 30
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cetilar® Cream in people with Knee Osteoarthristis, run by Pharmanutra S.p.a. at 4 sites in Georgia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Walking Arthritis Pain Intensity Score (VAS) (time frame: day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.