Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00108810
Status:
COMPLETED
Last Update Posted:
2012-06-05
First Post:
2005-04-18
Brief Title:
Transdermal Ketoprofen to Treat Mild to Moderate Osteoarthritis OA Pain of the Knee
Sponsor:
ZARS Pharma Inc
Organization:
ZARS Pharma Inc
Study Overview
Official Title:
Randomized Double-Blind Parallel Placebo Controlled 4 Week Proof-of-Concept Study to Evaluate the Safety and Efficacy of Transdermal Ketoprofen When Administered With Controlled Heat in Patients With Mild to Moderate OA Pain of the Knee
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:
The purpose of the study is to evaluate the safety and effectiveness of the investigational ketoprofen patch with a controlled heating patch compared to placebo inactive substance for the treatment of pain caused by osteoarthritis
Detailed Description:
Proof-of-concept study multicenter randomized double-blind parallel-group placebo-controlled study designed to evaluate the safety and efficacy of a transdermal ketoprofen patch with CHADD heat versus a placebo patch with dummy heat in patients with mild to moderate pain associated with osteoarthritis of the knee After screening patients discontinue all analgesic medication except 325 mg aspirin daily for cardioprotective purposes Patients selected a target knee right or left and all efficacy evaluations were completed with respect to this target knee After discontinuing analgesics for at least 48 hours and when the average pain intensity over the previous 24 hours for the target knee was 40 mm using a 100 mm visual analog scale VAS patients were randomized in a 11 fashion to receive treatment with either the transdermal ketoprofen patch with CHADD heat or the placebo patch with dummy heat Patients treated the target knee each night for 12 hours 1 hour for 4 weeks Patients returned to the study site every 7 days 1 day for study evaluations Throughout the study patients were allowed to take up to 2000 mg acetaminophen per day as rescue medication however rescue medication was not allowed within the 48 hours prior to efficacy evaluations
Study Oversight
Has Oversight DMC:
None
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?:
None