Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00255983
Status:
TERMINATED
Last Update Posted:
2008-06-03
First Post:
2005-11-16
Brief Title:
A Trial to Evaluate the Efficacy and Safety of Faropenem Medoxomil In the Treatment of Chronic Bronchitis
Sponsor:
Replidyne
Organization:
Replidyne
Study Overview
Official Title:
Prospective Randomized Double-Blind Trial to Evaluate the Efficacy and Safety of Faropenem Medoxomil 600 mg PO BID for 5 Days Versus Placebo In the Treatment of Acute Exacerbation of Chronic Bronchitis
Status:
TERMINATED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
financial reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Identifying the role of antibiotics in the treatment of subjects with a microbiologically documented acute exacerbation of chronic bronchitis AECB is the purpose of this clinical trial The trial has been designed to evaluate the efficacy and safety of faropenem medoxomil versus placebo in the treatment of subjects with microbiologically documented AECB
Detailed Description:
This is a multi-center multi-national prospective randomized double-blind placebo-controlled study to evaluate the efficacy and safetytolerability of faropenem medoxomil versus placebo in the treatment of subjects with a primary diagnosis of AECB All subjects will have a pre-therapy sputum specimen obtained for culture and susceptibility testing
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