Clinical trial NCT00532038: 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.
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: Osteoarthritis
Pain
Lead sponsor: ZARS Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2007-09-19
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate the safety of long-term administration of ThermoProfen™
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
state: California
city: San Diego
country: United States
state: California
city: Westlake Village
country: United States
state: California
city: Clearwater
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Springfield
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: Overland Park
country: United States
state: Kansas
city: Baltimore
country: United States
state: Maryland
city: Wheaton
country: United States
state: Maryland
city: Kansas City
country: United States
state: Missouri
city: Mercerville
country: United States
state: New Jersey
city: Raleigh
country: United States
state: North Carolina
city: Lake Oswego
country: United States
state: Oregon
city: Duncansville
country: United States
state: Pennsylvania
city: Erie
country: United States
state: Pennsylvania
city: Anderson
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: ZARS Pharma
name: Medical Monitor
role: STUDY_DIRECTOR
References: