Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00365586
Status:
COMPLETED
Last Update Posted:
2020-02-19
First Post:
2006-08-16
Brief Title:
Ketoprofen Topical Patch 20 in the Treatment of Pain Associated With Osteoarthritis Flare of the Knee
Sponsor:
APR Applied Pharma Research sa
Organization:
APR Applied Pharma Research sa
Study Overview
Official Title:
A Phase III Study of the Efficacy Tolerability and Safety of the Ketoprofen Topical Patch 20 KTP in the Treatment of Pain Associated With Osteoarthritis Flare of the Knee Including a Randomized Double-Blind Placebo-Controlled Parallel Group Phase Followed by an Open-Label Treatment Phase
Status:
COMPLETED
Status Verified Date:
2020-02
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 this study is to evaluate the effect of a ketoprofen topical patch on the pain associated with Osteoarthritis Flare of the Knee
Detailed Description:
This randomized double-blind placebo-controlled parallel group study will be conducted with patients who have experienced a flare of osteoarthritis of the knee At screening patients whose pain is currently controlled by an analgesic will agree after giving Informed Consent to discontinue that analgesic Eligible patients will be randomized 11 ratio to receive double-blind treatment with either the ketoprofen topical patch or a matching placebo patch to be applied once daily for 28 days Patients will return to the clinic on Days 7 14 21 and 28 At Day 28 patients may choose to open a 2 month open-label period
Patients will rate their pain using the Knee Injury and Osteoarthritis Outcome Score KOOS which contains the WOMAC pain subscale Patients will also complete an electronic diary in which pain intensity pain relief and quality of sleep ratings will be captured In addition rescue medication consumption data will be collected Ibuprofen will be provided as prn rescue medication
Patients will rate their pain using the Knee Injury and Osteoarthritis Outcome Score KOOS which contains the WOMAC pain subscale Patients will also complete an electronic diary in which pain intensity pain relief and quality of sleep ratings will be captured In addition rescue medication consumption data will be collected Ibuprofen will be provided as prn rescue medication
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