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.

ZARS Pharma

Status and phase

Terminated

Phase 3

Conditions

Osteoarthritis

Treatments

Drug: ThermoProfen™ (Matrix Transdermal Ketoprofen/CHADD™ System)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00532038

ZMK-304

Details and patient eligibility

About

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.

Full 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.

Enrollment

179 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.