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Clinical Trials to Assess the Efficacy and Safety of HLIM

Primary Purpose

Acute Upper Respiratory Tract Infection, Acute Bronchitis

Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Test
Active Comparator Control 1
Active Comparator Control 2
Placebo
Sponsored by
SamA Pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Upper Respiratory Tract Infection

Eligibility Criteria

2 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Korea University Guro HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

HLIM

SA160021

SA160022

Placebo

Arm Description

HLIM+SA160021 Placebo+SA160022 Placebo

HLIM Placebo+SA160021+SA160022 Placebo

HLIM Placebo+SA160021 Placebo+SA160022

HLIM Placebo+SA160021 Placebo+SA160022 Placebo

Outcomes

Primary Outcome Measures

Changes in BSS(Bronchitis Severity Score)-cough domain of active comparator control 2 versus placebo
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
0(absent) ~ 4(very severe), Total Score: 0~20

Secondary Outcome Measures

Full Information

First Posted
January 10, 2019
Last Updated
February 7, 2019
Sponsor
SamA Pharmaceutical Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03827590
Brief Title
Clinical Trials to Assess the Efficacy and Safety of HLIM
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 29, 2018 (Actual)
Primary Completion Date
May 30, 2019 (Anticipated)
Study Completion Date
October 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SamA Pharmaceutical Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Upper Respiratory Tract Infection, Acute Bronchitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
487 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HLIM
Arm Type
Experimental
Arm Description
HLIM+SA160021 Placebo+SA160022 Placebo
Arm Title
SA160021
Arm Type
Active Comparator
Arm Description
HLIM Placebo+SA160021+SA160022 Placebo
Arm Title
SA160022
Arm Type
Active Comparator
Arm Description
HLIM Placebo+SA160021 Placebo+SA160022
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
HLIM Placebo+SA160021 Placebo+SA160022 Placebo
Intervention Type
Drug
Intervention Name(s)
Test
Other Intervention Name(s)
HLIM+SA160021 Placebo+SA160022 Placebo
Intervention Description
three times a day for five days
Intervention Type
Drug
Intervention Name(s)
Active Comparator Control 1
Other Intervention Name(s)
HLIM Placebo+SA160021+SA160022 Placebo
Intervention Description
three times a day for five days
Intervention Type
Drug
Intervention Name(s)
Active Comparator Control 2
Other Intervention Name(s)
HLIM Placebo+SA160021 Placebo+SA160022
Intervention Description
three times a day for five days
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
HLIM Placebo+SA160021 Placebo+SA160022 Placebo
Intervention Description
three times a day for five days
Primary Outcome Measure Information:
Title
Changes in BSS(Bronchitis Severity Score)-cough domain of active comparator control 2 versus placebo
Description
0(absent) ~ 4(very severe), Total Score: 0~20
Time Frame
5 days
Title
Changes in BSS(Bronchitis Severity Score) total score of each active comparator control group compared to the test group
Description
0(absent) ~ 4(very severe), Total Score: 0~20
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Korea University Guro Hospital
City
Seoul
State/Province
Guro-gu
ZIP/Postal Code
08308
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaejung Shim, M.D., Ph.D
Phone
+82-2-2626-1114
Email
jaejshim@kumc.or.kr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Clinical Trials to Assess the Efficacy and Safety of HLIM

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