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

• Patient global assessment of response to therapy [ Time Frame: week 12 ] [ Designated as safety issue: No ]
• function subscale of the WOMAC [ Time Frame: week 12 ] [ Designated as safety issue: No ]

The purpose of this study is to provide replicated evidence of safety and efficacy of 50 mg and 100 mg ketoprofen in Diractin®.

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.

• Drug: ketoprofen in Diractin®
  50 mg (b.i.d.)
• Drug: ketoprofen in Diractin®
  100 mg (b.i.d.)
• Drug: Placebo
  b.i.d.
• Drug: celecoxib
  100 mg (b.i.d.)

• Experimental: 1
  Intervention: Drug: ketoprofen in Diractin®
• Experimental: 2
  Intervention: Drug: ketoprofen in Diractin®
• Active Comparator: 3
  Intervention: Drug: celecoxib
• Placebo Comparator: 4
  Intervention: Drug: Placebo

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