Phase III Clinical Trials to Assess the Efficacy and Safety of HLIM for Symptomatic Relief of Cough and Sputum in Patients With Acute Upper Respiratory Tract Infection or Acute Bronchitis
Overview
- Phase
- Phase 3
- Intervention
- Test
- Conditions
- Acute Upper Respiratory Tract Infection
- Sponsor
- SamA Pharmaceutical Co., Ltd
- Enrollment
- 487
- Locations
- 1
- Primary Endpoint
- Changes in BSS(Bronchitis Severity Score)-cough domain of active comparator control 2 versus placebo
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to assess the efficacy and safety of HLIM
Detailed Description
A randomized, double-blind, active-controlled, multicenter phase 3 clinical trial.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age between 2 and 75
- •Weight more than 11.5 kg
Exclusion Criteria
- •Has a history of hypersensitivity to IP ingredients
- •Hypertension or Diabetes
- •Smoking more than 20 pack-years
Arms & Interventions
HLIM
HLIM+SA160021 Placebo+SA160022 Placebo
Intervention: Test
SA160021
HLIM Placebo+SA160021+SA160022 Placebo
Intervention: Active Comparator Control 1
SA160022
HLIM Placebo+SA160021 Placebo+SA160022
Intervention: Active Comparator Control 2
Placebo
HLIM Placebo+SA160021 Placebo+SA160022 Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Changes in BSS(Bronchitis Severity Score)-cough domain of active comparator control 2 versus placebo
Time Frame: 5 days
0(absent) \~ 4(very severe), Total Score: 0\~20
Changes in BSS(Bronchitis Severity Score) total score of each active comparator control group compared to the test group
Time Frame: 5 days
0(absent) \~ 4(very severe), Total Score: 0\~20