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.

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00532038
• Other study ID #: ZMK-304
• Status: Terminated
• Phase: Phase 3
• First received: September 18, 2007
• Last updated: March 14, 2012
• Start date: September 2007
• Est. completion date: November 2008

Study information

• Verified date: March 2012
• Source: ZARS Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 179
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ZARS Pharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety of long-term administration of ThermoProfen™		up to 12 months	Yes