Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2026-04-15 @ 6:43 AM
Study NCT ID:
NCT02151734
Status:
COMPLETED
Last Update Posted:
2014-05-30
First Post:
2014-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of KALOMIN™ Tab. in Patients With Acute Bronchitis
Sponsor:
Korea United Pharm. Inc.
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2014-05
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:
This is a multi-center, double-dummy, double-blind, randomized, active-controlled, parallel group phase 3 clinical trial to evaluate the efficacy and safety of KALOMIN™ Tab. in patients with acute bronchitis.
The aim of this clinical trial is to demonstrate that KALOMIN™ Tab. is clinically non-inferior to Umckamin syrup, as assessed by BSS(Bronchitis Severity Score), in the treatment of acute bronchitis after 7 days.
The aim of this clinical trial is to demonstrate that KALOMIN™ Tab. is clinically non-inferior to Umckamin syrup, as assessed by BSS(Bronchitis Severity Score), in the treatment of acute bronchitis after 7 days.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: