Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-01 @ 4:19 AM
Study NCT ID:
NCT00488267
Status:
COMPLETED
Last Update Posted:
2012-05-30
First Post:
2007-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of ThermoProfen in Patients With Mild to Moderate Pain Associated With Osteoarthritis of the Knee
Sponsor:
ZARS Pharma Inc.
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, 12-Week Study to Evaluate the Efficacy of ThermoProfen™ in the Treatment of Patients With Mild to Moderate Pain Associated With Osteoarthritis of the Knee (ZMK-301)
Status:
COMPLETED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ThermoProfen for the treatment of mild to moderate pain associated with osteoarthritis of the knee in adults.
Detailed Description:
The primary objective of the study is to compare the efficacy of ThermoProfen™ against two other experimental treatments.
The treatment may be ThermoProfen (Matrix Transdermal Ketoprofen Patch) or a patch that may or may not include ketoprofen and that may or may not provide heat.
The treatment may be ThermoProfen (Matrix Transdermal Ketoprofen Patch) or a patch that may or may not include ketoprofen and that may or may not provide heat.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: