Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT02106793
Status:
COMPLETED
Last Update Posted:
2018-05-23
First Post:
2014-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mitomicin C for Prevention Postoperative Endoscopic Sinus Surgery Synechia and QOL in Chronic Rhinosinusitis
Sponsor:
Mahidol University
Organization:
Study Overview
Official Title:
Comparing Effect of Mitomicin C Versus Placebo for Prevention of Postoperative Endoscopic Sinus Surgery Synechia and Impact on Quality of Life in Thai Patients With Chronic Rhinosinusitis
Status:
COMPLETED
Status Verified Date:
2018-05
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:
Primary objective
* To compare the incidence of postoperative nasal synerchia between Mitomicin C and placebo in patients at 6 months after endoscopic sinus surgery
* To validate the Thai version of disease-specific quality of life tool SNOT-22
Secondary objectives
* To compare the clinical signs and symptoms of CRS in patients who receive Mitomicin C with those who receive placebo
* To compare the disease-specific quality of life in patients who receive Mitomicin C with those who receive placebo
* To compare the side effects of Mitomicin C versus placebo
* To compare the incidence of postoperative nasal synerchia between Mitomicin C and placebo in patients at 6 months after endoscopic sinus surgery
* To validate the Thai version of disease-specific quality of life tool SNOT-22
Secondary objectives
* To compare the clinical signs and symptoms of CRS in patients who receive Mitomicin C with those who receive placebo
* To compare the disease-specific quality of life in patients who receive Mitomicin C with those who receive placebo
* To compare the side effects of Mitomicin C versus placebo
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: