Study of Safety and Efficacy of Diractin® for the Treatment of Osteoarthritis (OA) of the Knee

Study Overview
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Brief Summary
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The purpose of this study is to provide replicated evidence of safety and efficacy of 100 mg ketoprofen in Diractin®.

Detailed Description
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The study will investigate safety and efficacy of Diractin® at relieving signs and symptoms of knee OA, including the primary endpoint of patient assessment of pain.

Official Title
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Multicentre, Randomized, Double-blind, Placebo-controlled Study of Safety and Efficacy of Epicutaneously Applied Diractin® (Ketoprofen in Transfersome® Gel) for the Treatment of Osteoarthritis of the Knee

Conditions
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Osteoarthritis of the Knee

Intervention / Treatment
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* Drug: ketoprofen in Diractin®
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent signed and dated Age > 45 years Class I-III OA of the knee and subject meets American College of Rheumatology (ACR) clinical classification criteria for osteoarthritis of the knee Exclusion Criteria: Skin lesions or dermatological diseases in the treatment area Directly or indirectly involved in the conduct and administration of this study Received any investigational medicinal product within 30 days prior to Screening Visit or participation in any previous clinical study with Diractin® Pregnancy or lactation Residents of psychiatric wards, prisons or other state institutions Malignancy within the past 2 years Depressive disorders requiring treatment with tricyclics, treatment with other antidepressants must be stable for 3 months prior to screening and throughout the study Epilepsy Schizophrenia Neuropathic pain and any other pain condition requiring chronic use of pain medication Known hypersensitivity or allergy (including photoallergy) to NSAID´s including ketoprofen and to ingredients of the IMP Preexisting asthma or bronchospasm after taking aspirin or other NSAIDs Unable to discontinue analgesic therapy including opioids, NSAID´s, tramadol, muscle relaxants, gabapentin, pregabalin, duloxetine, venlafaxine, capsaicine or other drugs approved or used for the treatment of pain for the duration of the study

Ages Eligible for Study
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Minimum Age: 46 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: ketoprofen in Diractin®<br>* 100 mg (b.i.d.)<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* 100 mg (b.i.d.)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain subscale of the WOMAC |  | week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient global assessment of response to therapy |  | week 12 | 
| function subscale of the WOMAC |  | week 12 |