Clareo Health | A Phase 3 Study to Evaluate the Long-Term Safety of ThermoProfen™ in Patients With Mild to Moderate Pain Associated With Osteoarthritis of the Knee.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
ZARS Pharma Inc.
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.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patient completed a previous efficacy study of ThermoProfen.
You may not be if
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.
