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COMPLETED Phase 3

Efficacy of ThermoProfen in Patients With Mild to Moderate Pain Associated With Osteoarthritis of the Knee

NCT00488267 · View on ClinicalTrials.gov ↗

Study 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 ThermoProfen for the treatment of mild to moderate pain associated with osteoarthritis of the knee in adults.

Conditions Studied

Interventions

  • DRUG ThermoProfen™ (Matrix Transdermal Ketoprofen/CHADD™ System)
  • DRUG Placebo Matrix/CHADD Patch
  • DRUG Ketoprofen matrix/placebo CHADD Patch

Study Locations (20)

Florida

  • — Clearwater
  • — Jupiter
  • — Pembroke Pines
  • — South Miami
  • — Tampa

California

  • — Anaheim
  • — Buena Park
  • — San Diego
  • — Westlake Village

Connecticut

  • — Hamden
  • — Milford

Maryland

  • — Baltimore
  • — Wheaton

Arizona

  • — Peoria

Idaho

  • — Boise

Illinois

  • — Springfield

Indiana

  • — Evansville

Trial Details

FieldValue
Enrollment Target 679 participants
Start Date 2007-06
Est. Completion 2008-09
Phase Phase 3

Sponsor

ZARS Pharma

6 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00488267

The ClinicalTrials.gov registry entry for NCT00488267 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 679 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ZARS Pharma, which has 6 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Osteoarthritis appearing as the primary indexed condition, and to 3 interventions — of which ThermoProfen™ (Matrix Transdermal Ketoprofen/CHADD™ System) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00488267 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, California, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00488267 about?

NCT00488267 is a clinical study titled "Efficacy of ThermoProfen in Patients With 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 ThermoProfen for the treatment of mild to moderate pain associated with...

What is the current status of trial NCT00488267?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 679 participants. The study started on 2007-06. Estimated completion is 2008-09.

What conditions does trial NCT00488267 study?

This clinical trial studies the following conditions: Osteoarthritis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00488267?

The interventions under investigation include: ThermoProfen™ (Matrix Transdermal Ketoprofen/CHADD™ System) (DRUG), Placebo Matrix/CHADD Patch (DRUG), Ketoprofen matrix/placebo CHADD Patch (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00488267?

This trial is sponsored by ZARS Pharma, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00488267 being conducted?

This trial has 20 study locations across Arizona, California, Connecticut, Florida, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial