Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00425620
Status:
COMPLETED
Last Update Posted:
2007-11-30
First Post:
2007-01-19
Brief Title:
Amphotericin B Suspension in Refractory Chronic Sinusitis
Sponsor:
Accentia Biopharmaceuticals
Organization:
Accentia Biopharmaceuticals
Study Overview
Official Title:
A Prospective Randomized Double-Blind Placebo-Controlled Multicenter Parallel-Group Study of Intranasal Amphotericin B Suspension in Patients With Refractory Postsurgical Chronic Sinusitis CS
Status:
COMPLETED
Status Verified Date:
2007-11
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:
The primary objective of the study is to evaluate the safety and efficacy of Amphotericin B suspension versus placebo in the complete resolution of key chronic sinusitis symptoms during 16 weeks of treatment in patients with refractory postsurgical CS
Detailed Description:
None
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