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

Pro Bono Bio

Status: Unknown

Conditions: Osteoarthritis

Treatments: Device: Placebo; Device: FLEXISEQ®

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02594176

CL-064-IV-01 (IMR-062)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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600 participants in 2 patient groups, including a placebo group

Test Product

Experimental group

Description:

2.2 g FLEXISEQ® twice daily

Treatment:

Device: FLEXISEQ®

Placebo

Placebo Comparator group

Description:

2.2 g placebo twice daily

Treatment:

Device: Placebo