Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT01726920
Status:
WITHDRAWN
Last Update Posted:
2016-03-16
First Post:
2012-11-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of a Fixed-dose Combination of Naratriptan and Naproxen in Acute Treatment of Migraine.
Sponsor:
Ache Laboratorios Farmaceuticos S.A.
Organization:
Study Overview
Official Title:
A Phase III, Multicenter, National, Open, Randomized, Parallel and Comparative Study to Evaluate the Efficacy and Safety of a Fixed-dose Combination of Naratriptan 2,5 mg + Naproxen 500 mg for the Acute Treatment of Migraine.
Status:
WITHDRAWN
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to budget limitations, the company decided to withdraw this study.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Copérnico
Brief Summary:
The purpose of this study is to determine whether a fixed-dose combination of naratriptan 2,5 mg + naproxen 500 mg is effective and safe compared each monotherapy for the acute treatment of migraine.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: