Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00351104
Status:
COMPLETED
Last Update Posted:
2020-02-19
First Post:
2006-06-30
Brief Title:
Efficacy and Safety of Ketoprofen Topical Patch 20 in the Treatment of Pain Associated With Ankle Sprain or Strain
Sponsor:
APR Applied Pharma Research sa
Organization:
APR Applied Pharma Research sa
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Parallel Group Phase III Study of the Efficacy Tolerability and Safety of Ketoprofen Topical Patch 20 KTP in the Treatment of Pain Associated With Grade 1 or Grade 2 Ankle Sprain or Strain
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 ankle sprain or strain
Detailed Description:
This randomized double-blind placebo-controlled parallel group study will be conducted in patients with Grade 1 or Grade 2 ankle sprains or strains Eligible patients will be randomized in a 11 ratio to receive double-blind treatment with either the KTP or a matching placebo patch to be applied once daily for 14 days Patients will return to the clinic for assessments on Day 3 Day 7 and Day 14 a follow-up assessment will be conducted by telephone on Day 28 At each visit through Day 14 patients will rate their average pain intensity during daily activities and while at rest using an 11-point scale and will rate their functional disability Patients will also complete an electronic diary in which pain intensity and pain relief ratings will be recorded three times daily Ratings of the quality of sleep will be recorded in the diary each morning and the use of study treatment and rescue medication will be recorded in the diary each day Ibuprofen will be provided as 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