drugset / Trial / NCT02151734

Safety and Efficacy of KALOMIN™ Tab. in Patients With Acute Bronchitis

NCT02151734

Phase 3 Completed 242 enrolled Korea United Pharm. Inc.
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2013-08
Primary completion
2013-12
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject KALOMIN™ Tab. Unknown
Comparator Pelargonium sidoides extract Unknown

Indications