Status:
COMPLETED
Study of Safety and Efficacy of Diractin® for the Treatment of Osteoarthritis (OA) of the Knee
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 100 mg ketoprofen in Diractin®.
Detailed Description
The study will investigate safety and efficacy of Diractin® at relieving 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 and to ingredients of the IMP
- Preexisting asthma or bronchospasm after taking aspirin or other NSAIDs
- 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 :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
555 Patients enrolled
Trial Details
Trial ID
NCT00722852
Start Date
June 1 2008
End Date
April 1 2009
Last Update
October 5 2009
Active Locations (37)
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1
Hope Research Institute
Phoenix, Arizona, United States, 85016
2
Premiere Pharmaceutical Research
Tempe, Arizona, United States, 85282
3
Genova Clinical Research
Tucson, Arizona, United States, 85741
4
Family Practice Lynn Institute of the Ozarks
Little Rock, Arkansas, United States, 72205