Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT01172405
Status:
UNKNOWN
Last Update Posted:
2010-07-29
First Post:
2010-07-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study to Compare Ibuprofen + Caffeine With Ibuprofen Alone in the Treatment of Headache
Sponsor:
Mantecorp Industria Quimica e Farmaceutica Ltd.
Organization:
Study Overview
Official Title:
A Clinical Multicenter, Phase III, Randomized, Double-blind, Prospective and Comparative Trial to Evaluate the Efficacy and Safety of the Combination of Ibuprofen + Caffeine in the Treatment of Headache Attacks, Compared to Ibuprofen Alone.
Status:
UNKNOWN
Status Verified Date:
2010-07
Last Known Status:
NOT_YET_RECRUITING
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:
Based on established therapeutic effect of ibuprofen in the treatment of headache attacks, and the action of caffeine in promoting better results when combined with treatments of first choice in the treatment of headache, this study is designed to:
* evaluate the efficacy of therapy with ibuprofen + caffeine in headache patients compared to ibuprofen alone;
* evaluate the tolerability of the association ibuprofen + caffeine compared to ibuprofen alone.
The hypothesis is that the association is superior to treatment with ibuprofen alone in terms of efficacy, while maintaining good tolerability.
* evaluate the efficacy of therapy with ibuprofen + caffeine in headache patients compared to ibuprofen alone;
* evaluate the tolerability of the association ibuprofen + caffeine compared to ibuprofen alone.
The hypothesis is that the association is superior to treatment with ibuprofen alone in terms of efficacy, while maintaining good tolerability.
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?: