Ignite Creation Date:
2025-12-24 @ 9:31 PM
Ignite Modification Date:
2025-12-29 @ 4:07 AM
Study NCT ID:
NCT00433732
Status:
COMPLETED
Last Update Posted:
2007-02-12
First Post:
2007-02-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Safety and Efficacy of Trexima in the Acute Treatment of Migraine Headaches
Sponsor:
POZEN
Organization:
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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: