Ignite Creation Date:
2024-05-06 @ 12:28 AM
Last Modification Date:
2024-10-26 @ 10:50 AM
Study NCT ID:
NCT01587508
Status:
WITHDRAWN
Last Update Posted:
2016-05-03
First Post:
2012-04-24
Brief Title:
Study Comparing A New Drug Containing The Combination Meloxicam And Cyclobenzaprine In The Treatment Of Acute Lumbago
Sponsor:
Eurofarma Laboratorios SA
Organization:
Eurofarma Laboratorios SA
Study Overview
Official Title:
A Phase III Randomized Single-Blind Superiority Study Comparing The Efficacy And Tolerability Of A New Drug Containing The Combination Meloxicam And Cyclobenzaprine And The Same Components Alone In The Treatment Of Acute Lumbago
Status:
WITHDRAWN
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The comparator product was withdrawn from the brazilian market not being possible to conduct the design regarding initially planned
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the efficacy end tolerability of a new drug containing the combination meloxicam and cyclobenzaprine 7510mg and the same components alone in the treatment of acute lumbago
Detailed Description:
To assess the efficacy and tolerability of a new drug containing the combination meloxicam and cyclobenzaprine in the treatment of acute lumbago compared to the same components alone
Some eligibility criteria
Have a normal X-ray of the lumbar spine for the age Have a baseline score in the VAS higher than or equal to 40 mm
Some eligibility criteria
Have a normal X-ray of the lumbar spine for the age Have a baseline score in the VAS higher than or equal to 40 mm
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