Ignite Creation Date:
2024-05-05 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00433732
Status:
COMPLETED
Last Update Posted:
2007-02-12
First Post:
2007-02-08
Brief Title:
To Evaluate the Safety and Efficacy of Trexima in the Acute Treatment of Migraine Headaches
Sponsor:
POZEN
Organization:
POZEN
Study Overview
Official Title:
A Double-Blind Multicenter Randomized Placebo-Controlled Single Dose Study to Evaluate the Safety and Efficacy Opf Trexima in the Acute Treatment of Migraine Headaches
Status:
COMPLETED
Status Verified Date:
2005-04
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:
To determine the efficacy of the Trexima versus placebo as assessed by pain relief and the incidences of photophobia phonophobia and nausea at 2 hours after treatment as the primary endpoints
Detailed Description:
The primary objective of this study is to determine the efficacy of the Trexima versus placebo as assessed by pain relief and the incidences of photophobia phonophobia and nausea at 2 hours after treatment as the primary endpoints Another objective of this study is to evaluate the efficacy of Trexima when compared to the individual components sumatriptan and naproxen sodium using sustained pain-free as the endpoint It is the intent that this study be sufficiently powered to detect differences that are clinically meaningful and statistically significant in order to meet both objectives
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