ThermoProfen is a transdermal ketoprofen patch that is integrated with a long-lasting CHADD (Controlled Heat-Assisted Drug Delivery) unit for the treatment of chronic pain associated with osteoarthritis. This study will evaluate ThermoProfen for the treatment of mild to moderate pain associated with osteoarthritis of the knee in adults.
The primary objective of the study is to compare the efficacy of ThermoProfen™ against two other experimental treatments. The treatment may be ThermoProfen (Matrix Transdermal Ketoprofen Patch) or a patch that may or may not include ketoprofen and that may or may not provide heat.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
679
Transdermal patch applied to the knee for 12 hours daily.
Transdermal patch applied to the knee for 12 hours daily.
Transdermal knee applied to the knee for 12 hours daily.
The primary outcome measure is the change from baseline in the Visual Analog Scale score for the average pain during the previous 24 hours.
Time frame: 12 weeks
Change from baseline in Visual Analog Scale score for worst pain during the previous 24 hours, amount of rescue medication used to treat the target joint per day, and the patient global impression of change in the Likert Scale
Time frame: 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Peoria, Arizona, United States
Unnamed facility
Anaheim, California, United States
Unnamed facility
Buena Park, California, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
Westlake Village, California, United States
Unnamed facility
Hamden, Connecticut, United States
Unnamed facility
Milford, Connecticut, United States
Unnamed facility
Clearwater, Florida, United States
Unnamed facility
Jupiter, Florida, United States
Unnamed facility
Pembroke Pines, Florida, United States
...and 26 more locations