Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00434083
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 Migrane 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 of Trexima in the Acute Treatment of Migrane Headaches
Status:
COMPLETED
Status Verified Date:
2007-02
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:
to demonstrate the superiority of Trexima combination of sumatriptan as the succinate 85 mg and naproxen sodium 500 mg versus placebo in the acute treatment of migraine
to demonstrate the superiority of Trexima versus the individual components sumatriptan as the succinate 85 mg and naproxen sodium 500 mg and
to evaluate the safety of the Trexima
to demonstrate the superiority of Trexima versus the individual components sumatriptan as the succinate 85 mg and naproxen sodium 500 mg and
to evaluate the safety of the Trexima
Detailed Description:
None
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