Study of FLEXISEQ® for Treatment of Osteoarthritis of the Knee in NSAID-compromised Patients

Study Overview
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Brief Summary
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Primary Objective To substantiate the efficacy of 2.2 g FLEXISEQ® for the treatment of pain related to osteoarthritis (OA) of the knee in patients contraindicated for or with clinical intolerance to NSAIDs. Secondary Objectives To substantiate the efficacy of 2.2 g FLEXISEQ® for the treatment of stiffness and improvement of joint function in patients contraindicated for or with clinical intolerance to NSAIDs and with OA of the knee. To substantiate safety and tolerability of 2.2 g FLEXISEQ® in patients contraindicated for or with clinical intolerance to NSAIDs and with OA of the knee.

Detailed Description
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This post marketing clinical follow-up, randomised, double-blind study comparing the efficacy and tolerability of topical FLEXISEQ® with placebo for the treatment of osteoarthritis of the knee in patients contraindicated for or with clinical intolerance to NSAIDs and with OA of the knee will have a total individual treatment period of 12 weeks.

Official Title
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A Randomised, Double-blind, Placebo Controlled Study of Topical FLEXISEQ® for the Treatment of Osteoarthritis of the Knee in Patients Contraindicated for or With Clinical Intolerance to NSAIDs

Conditions
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Osteoarthritis

Intervention / Treatment
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* Device: FLEXISEQ®
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed and dated informed consent prior to any study-mandated procedure Willing and able to comply with study requirements Outpatients with an age ≥ 50 (starting from the day after the 50th birthday) Patient for whom their knee pain is the worst pain in the body and is able to identify the predominantly painful (target) knee Patient has a primary diagnosis of Functional Class I-III OA of the target knee and patient meets American College of Rheumatology (ACR) clinical classification criteria for osteoarthritis of the knee NSAID contraindicated or clinically intolerant Females able to conceive (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate If female and able to conceive, patient has a negative urine pregnancy test at screening Exclusion Criteria: General exclusion criteria Planned treatment or treatment with another investigational drug within 30 days prior to randomisation Patients who are inmates of psychiatric wards, prisons, or other state institutions Investigator or any other team member involved directly or indirectly in the conduct of the clinical study Pregnancy or lactation Any planned or expected hospitalisation within the study period Patients not able to perform the WOMAC test (physically handicapped or immobile patient, e.g. wheel-chair bound) Any health condition which, in the investigator's opinion means the patient is likely to be unable to complete the 12 week study Medical history related exclusion criteria Skin lesions or dermatological diseases in the treatment area Extreme obesity (BMI > 35) Uncontrolled hypertension Requiring dialysis Hepatocellular insufficiency preventing use of paracetamol Alcohol abuse Intolerance to paracetamol Malignancy within the past 2 years Morbus Meulengracht/Gilbert Syndrome Neurological or psychiatric disorders compromising pain rating by the patient, such as but not limited to depressive disorders, schizophrenia or epilepsy Any other pain condition requiring acute or chronic use of pain medication that cannot be discontinued at screening Inflammatory arthritis including rheumatoid arthritis, psoriatic arthritis, gout, pseudo gout, systemic lupus erythematodes, ankylosing spondylitis, mixed connective tissue disease Symptomatic hip OA ipsilateral to the target knee Severe (axial misalignment > 10°), uncorrected genu vara and genu valga Arthroscopy of the target knee within 6 months prior or during the study

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Product<br>2.2 g FLEXISEQ® twice daily | Device: FLEXISEQ®<br>* applicable gel<br>|
| Placebo Comparator: Placebo<br>2.2 g placebo twice daily | Device: Placebo<br>* applicable gel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC pain score | Change from baseline to final visit of the average of the WOMAC pain subscale scores | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Global Assessment of Change (PGIC) | PGIC-Score at final visit | 3 months | 
| WOMAC function score | Change from baseline to final visit of the average of the WOMAC function subscale scores | 3 months | 
| WOMAC stiffness score | Change from baseline to final visit of the average of the WOMAC stiffness subscale scores | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Pain, NSAID, Sequessome