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

Not Applicable

• Conditions: Osteoarthritis
• Interventions: Device: FLEXISEQ®; Device: Placebo

• Registration Number: NCT02594176
• Lead Sponsor: Pro Bono Bio

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-20
• Study First Submitted QC: 2015-10-30
• Study First Posted: 2015-11-01
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-02
• Last Update Posted: 2016-02-03
• Primary Completion: 2016-03
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test Product	FLEXISEQ®	2.2 g FLEXISEQ® twice daily
Placebo	Placebo	2.2 g placebo twice daily

Primary Outcome Measures

Name	Time	Method
WOMAC pain score	3 months	Change from baseline to final visit of the average of the WOMAC pain subscale scores

Secondary Outcome Measures

Name	Time	Method
Patient Global Assessment of Change (PGIC)	3 months	PGIC-Score at final visit
WOMAC function score	3 months	Change from baseline to final visit of the average of the WOMAC function subscale scores
WOMAC stiffness score	3 months	Change from baseline to final visit of the average of the WOMAC stiffness subscale scores

Trial Locations

Locations (1)

IMR-Site #1-30; 🇩🇪 Gräfelfing, Bavaria, Germany