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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.

This study has been terminated.
(Corporate decision)
Sponsor:
Information provided by (Responsible Party):
ZARS Pharma Inc.
ClinicalTrials.gov Identifier:
NCT00532038
First received: September 18, 2007
Last updated: March 14, 2012
Last verified: March 2012

September 18, 2007
March 14, 2012
September 2007
November 2008   (final data collection date for primary outcome measure)
To evaluate the safety of long-term administration of ThermoProfen™ [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]
To evaluate the safety of long-term administration of ThermoProfen™ [ Time Frame: up to 12 months ]
Complete list of historical versions of study NCT00532038 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.
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

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.

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.

Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Osteoarthritis
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
179
November 2008
November 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00532038
ZMK-304
No
ZARS Pharma Inc.
ZARS Pharma Inc.
Not Provided
Study Director: Medical Monitor ZARS Pharma
ZARS Pharma Inc.
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP