Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00135525
Status:
COMPLETED
Last Update Posted:
2011-01-31
First Post:
2005-08-24
Brief Title:
Study Of Generalized Anxiety Disorder
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Clinical Evaluation of BRL29060 A in Generalized Anxiety Disorder
Status:
COMPLETED
Status Verified Date:
2011-01
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:
This study is designed to evaluate the efficacy and safety in Generalized Anxiety Disorder patients
Detailed Description:
This study was a multi-center randomized placebo-controlled double-blinded placebo run-in will be single-blinded group comparison study
Paroxetine 20mgday achieved via the starting dose of 10 mgday for the first week once daily or placebo was orally administered once daily for 8 weeks fixed dose was adopted in the Treatment phase in patients with GAD
For subjects who were classed as non-responders at Week 8 paroxetine at 30 to 40mgday once daily or placebo once daily was orally administered with flexible titration regimen for 4 weeks fixed dose was adopted in the Treatment phase The subjects underwent a taper phase in case they received Paroxetine 40mgday paroxetine 30mgday or placebo at treatment completion or study withdrawal A follow-up examination was conducted after 1 to 5 weeks from the last dose of the investigational product
The overall study duration requiring subject participation was 10 to 20 weeks
Paroxetine 20mgday achieved via the starting dose of 10 mgday for the first week once daily or placebo was orally administered once daily for 8 weeks fixed dose was adopted in the Treatment phase in patients with GAD
For subjects who were classed as non-responders at Week 8 paroxetine at 30 to 40mgday once daily or placebo once daily was orally administered with flexible titration regimen for 4 weeks fixed dose was adopted in the Treatment phase The subjects underwent a taper phase in case they received Paroxetine 40mgday paroxetine 30mgday or placebo at treatment completion or study withdrawal A follow-up examination was conducted after 1 to 5 weeks from the last dose of the investigational product
The overall study duration requiring subject participation was 10 to 20 weeks
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