Safety and Efficacy of Two Dosages of Diractin® in Osteoarthritis (OA)

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 50 mg and 100 mg ketoprofen in Diractin®.

Detailed Description
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The study will investigate safety and efficacy of 2 dosages of Diractin®at relieving the signs and symptoms of knee OA, including the primary endpoint of patient assessment of pain.

Official Title
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Multicenter, Randomized, Double-blind, Placebo- and Active-controlled Study of Safety and Efficacy of Two Dosages 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: ketoprofen in Diractin®
* Drug: Placebo
* Drug: celecoxib


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, celecoxib, sulfonamides and ingredients used in pharmaceutical products including galactose Peripheral arterial disease and/or cerebrovascular disease History of stroke or myocardial infarction Congestive Heart failure NYHA Class II-IV History of pancreatitis or peptic ulcers; Inflammatory GI disease (e.g. M. Crohn, colitis ulcerosa) Serum creatinine levels > 2.5 milligrams/deciliter (mg/dL) ALT or AST levels ≥ 5 times the ULN 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>* 50 mg (b.i.d.)<br>|
| Experimental: 2<br> | Drug: ketoprofen in Diractin®<br>* 100 mg (b.i.d.)<br>|
| Active Comparator: 3<br> | Drug: celecoxib<br>* 100 mg (b.i.d.)<br>|
| Placebo Comparator: 4<br> | Drug: Placebo<br>* 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 |