Status:
COMPLETED
Safety and Efficacy of Two Dosages of Diractin® in Osteoarthritis (OA)
Lead Sponsor:
IDEA AG
Conditions:
Osteoarthritis of the Knee
Eligibility:
All Genders
46+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
1399 Patients enrolled
Trial Details
Trial ID
NCT00716547
Start Date
May 1 2008
End Date
May 1 2009
Last Update
October 16 2009
Active Locations (4)
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1
IDEA Investigational Site
Prague, Czechia, 128 50
2
Klaus-Miehlke-Klinik
Wiesbaden, Germany, 65191
3
NZOZ Nasz Lekarz
Torun, Poland, 87-100
4
Chapel Allerton Hospital
Leeds, United Kingdom, LS7 4SA