Osteoarthritis
Conditions
Keywords
Osteoarthritis, Pain
Brief summary
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 the safety of long-term administration of ThermoProfen™ for the pain associated with osteoarthritis of the knee in adults. The study will be conducted in patients with pain associated with osteoarthritis and who have completed a previous efficacy study of ThermoProfen.
Detailed description
The objective of the study is to evaluate the safety of long-term administration of ThermoProfen for the pain associated with osteoarthritis of the knee in adults.
Interventions
Patients will apply ThermoProfen daily for approximately 12 hours for up to 12 months for treatment of the pain associated with osteoarthritis of the knee.
Sponsors
ZARS Pharma Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patient completed a previous efficacy study of ThermoProfen.
Exclusion criteria
* Patient has a known allergy to nonsteroidal anti-inflammatory drugs (NSAIDs) (including aspirin). * Patient has a suspected hypersensitivity, allergy, or other contraindication to any compound present in the study medication or has a known sensitivity to adhesive components similar to those used in ThermoProfen (such as that found in adhesive bandages, e.g. Band-Aid®). * Patient has asthma that has been induced or made worse by the use of aspirin or any other NSAID. * Patient has a relevant history of serious gastrointestinal disease. * Patient has a defect, injury, or dermatologic disease or condition on the skin area where the study patch will be applied that may interfere with tolerability or post-application evaluations. * Patient has neurological or psychiatric disease sufficient to compromise data collection or integrity. * Patient is taking warfarin, heparin, or low molecular weight heparin. * Patient, if female, is pregnant or breastfeeding or is of childbearing potential and not practicing adequate birth control.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety of long-term administration of ThermoProfen™ | up to 12 months |
Countries
United States
Outcome results
None listed