An Open-Label, Long-Term Safety Study to Evaluate the Safety of ThermoProfen™ for the Treatment of Mild to Moderate Pain Associated With Osteoarthritis of the Knee
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- ZARS Pharma Inc.
- Enrollment
- 179
- Locations
- 20
- Primary Endpoint
- To evaluate the safety of long-term administration of ThermoProfen™
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
To evaluate the safety of long-term administration of ThermoProfen™
Time Frame: up to 12 months
Secondary Outcomes
No secondary outcomes reported