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

History of Changes

Tracking Information

First Received Date ^ICMJE

September 18, 2007

Last Updated Date

March 14, 2012

Start Date ^ICMJE

September 2007

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To evaluate the safety of long-term administration of ThermoProfen™ [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

To evaluate the safety of long-term administration of ThermoProfen™ [ Time Frame: up to 12 months ]

Change History

Complete list of historical versions of study NCT00532038 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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 ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Osteoarthritis

Intervention ^ICMJE

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.

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

179

Completion Date

November 2008

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00532038

Other Study ID Numbers ^ICMJE

ZMK-304

Has Data Monitoring Committee

Responsible Party

ZARS Pharma Inc.

Study Sponsor ^ICMJE

ZARS Pharma Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Monitor

ZARS Pharma

Information Provided By

ZARS Pharma Inc.

Verification Date

March 2012

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

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