Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00442221
Status:
COMPLETED
Last Update Posted:
2007-03-01
First Post:
2007-02-28
Brief Title:
The Safety Of Combo Formulation In The Treatment Of Multiple Episodes Of Acute Migraine Over 12 Months
Sponsor:
POZEN
Organization:
POZEN
Study Overview
Official Title:
An Open-Label Repeat Dose Study Of The Safety Of Combo Formulation In The Treatment Of Multiple Episodes Of Acute Migraine Over 12 Months
Status:
COMPLETED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to assess the safety of a single-tablet dose of Combo Formulation for the treatment of moderate to severe migraines
Detailed Description:
The objective of this study is to assess the safety of a single-tablet dose of Combo Formulation for the treatment of moderate to severe migraines with an optional second dose at least 2 hours following the first dose if needed Combo Formulation will be administered on average at least twice per month for 12 months
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