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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-10-31

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.

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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.

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Test Product

2.2 g FLEXISEQ® twice daily

Group Type EXPERIMENTAL

FLEXISEQ®

Intervention Type DEVICE

applicable gel

Placebo

2.2 g placebo twice daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DEVICE

applicable gel

Interventions

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FLEXISEQ®

applicable gel

Intervention Type DEVICE

Placebo

applicable gel

Intervention Type DEVICE

Eligibility Criteria

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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

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)
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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No