Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00347295
Status:
COMPLETED
Last Update Posted:
2017-12-28
First Post:
2006-06-30
Brief Title:
Randomised Double-blind Study to Investigate the Safety and Efficacy of Brotizolam in Insomnia Outpatients
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A Randomised Double-blinded Double-dummy Multi-center Paralleled Study to Investigate the Safety and Efficacy of Brotizolam Lendormin Compared With Estazolam in Insomnia Outpatients
Status:
COMPLETED
Status Verified Date:
2017-12
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 investigate the efficacy and safety of Brotizolam in the treatment of patients with insomnia in comparison with that of Estazolam
Detailed Description:
It is intended to recruit 240 insomnia outpatients in this study 120 patients receiving Brotizolam Estazolam placebo Test Group and 120 patients given Estazolam Brotizolam placebo Control Group
Study Hypothesis
Brotizolam can be safely used in insomnia patients in China And Brotizolam 025mg is non-inferior with Estazolam 1-2mg in treatment of insomnia patients in China
Comparisons
Estazolam 1-2mg
Study Hypothesis
Brotizolam can be safely used in insomnia patients in China And Brotizolam 025mg is non-inferior with Estazolam 1-2mg in treatment of insomnia patients in China
Comparisons
Estazolam 1-2mg
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