Safety and Efficacy of Two Dosages of Diractin® in Osteoarthritis (OA)
Phase 3
Completed
- Conditions
- Osteoarthritis of the Knee
- Interventions
- Registration Number
- NCT00716547
- Lead Sponsor
- IDEA AG
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1399
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 ketoprofen in Diractin® - 2 ketoprofen in Diractin® - 3 celecoxib - 4 Placebo -
- Primary Outcome Measures
Name Time Method pain subscale of the WOMAC week 12
- Secondary Outcome Measures
Name Time Method Patient global assessment of response to therapy week 12 function subscale of the WOMAC week 12
Trial Locations
- Locations (4)
Klaus-Miehlke-Klinik
🇩🇪Wiesbaden, Germany
IDEA Investigational Site
🇨🇿Prague 2, Czech Republic
NZOZ Nasz Lekarz
🇵🇱Torun, Poland
Chapel Allerton Hospital
🇬🇧Leeds, United Kingdom