Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
IDEA AG
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.
Age
46–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Study of Safety and Efficacy of Diractin® for the Treatment of Osteoarthritis (OA) of the Knee
