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

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IDEA AG
• Treatments: Celecoxib; Ketoprofen

Criteria

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