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

Launched by PRO BONO BIO · Oct 30, 2015

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Signed and dated informed consent prior to any study-mandated procedure
• • 2. Willing and able to comply with study requirements
• • 3. Outpatients with an age ≥ 50 (starting from the day after the 50th birthday)
• • 4. Patient for whom their knee pain is the worst pain in the body and is able to identify the predominantly painful (target) knee
• • 5. 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
• • 6. NSAID contraindicated or clinically intolerant
• • 7. 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
• • 8. If female and able to conceive, patient has a negative urine pregnancy test at screening
• Exclusion Criteria:
• • General exclusion criteria
• • 1. Planned treatment or treatment with another investigational drug within 30 days prior to randomisation
• • 2. Patients who are inmates of psychiatric wards, prisons, or other state institutions
• • 3. Investigator or any other team member involved directly or indirectly in the conduct of the clinical study
• • 4. Pregnancy or lactation
• • 5. Any planned or expected hospitalisation within the study period
• • 6. Patients not able to perform the WOMAC test (physically handicapped or immobile patient, e.g. wheel-chair bound)
• • 7. 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
• • 8. Skin lesions or dermatological diseases in the treatment area
• • 9. Extreme obesity (BMI \> 35)
• • 10. Uncontrolled hypertension
• • 11. Requiring dialysis
• • 12. Hepatocellular insufficiency preventing use of paracetamol
• • 13. Alcohol abuse
• • 14. Intolerance to paracetamol
• • 15. Malignancy within the past 2 years
• • 16. Morbus Meulengracht/Gilbert Syndrome
• • 17. Neurological or psychiatric disorders compromising pain rating by the patient, such as but not limited to depressive disorders, schizophrenia or epilepsy
• • 18. Any other pain condition requiring acute or chronic use of pain medication that cannot be discontinued at screening
• • 19. Inflammatory arthritis including rheumatoid arthritis, psoriatic arthritis, gout, pseudo gout, systemic lupus erythematodes, ankylosing spondylitis, mixed connective tissue disease
• • 20. Symptomatic hip OA ipsilateral to the target knee
• • 21. Severe (axial misalignment \> 10°), uncorrected genu vara and genu valga
• • 22. Arthroscopy of the target knee within 6 months prior or during the study