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Clinical Trials to Assess the Efficacy and Safety of HLIM

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ClinicalTrials.gov Identifier: NCT03827590
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
SamA Pharmaceutical Co., Ltd

Brief Summary:
The purpose of this study is to assess the efficacy and safety of HLIM

Condition or disease Intervention/treatment Phase
Acute Upper Respiratory Tract Infection Acute Bronchitis Drug: Test Drug: Active Comparator Control 1 Drug: Active Comparator Control 2 Drug: Placebo Phase 3

Detailed Description:
A randomized, double-blind, active-controlled, multicenter phase 3 clinical trial.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 487 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : November 29, 2018
Estimated Primary Completion Date : May 30, 2019
Estimated Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acute Bronchitis

Arm Intervention/treatment
Experimental: HLIM
HLIM+SA160021 Placebo+SA160022 Placebo
Drug: Test
three times a day for five days
Other Name: HLIM+SA160021 Placebo+SA160022 Placebo

Active Comparator: SA160021
HLIM Placebo+SA160021+SA160022 Placebo
Drug: Active Comparator Control 1
three times a day for five days
Other Name: HLIM Placebo+SA160021+SA160022 Placebo

Active Comparator: SA160022
HLIM Placebo+SA160021 Placebo+SA160022
Drug: Active Comparator Control 2
three times a day for five days
Other Name: HLIM Placebo+SA160021 Placebo+SA160022

Placebo Comparator: Placebo
HLIM Placebo+SA160021 Placebo+SA160022 Placebo
Drug: Placebo
three times a day for five days
Other Name: HLIM Placebo+SA160021 Placebo+SA160022 Placebo




Primary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   2 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03827590


Locations
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Korea, Republic of
Korea University Guro Hospital Recruiting
Seoul, Guro-gu, Korea, Republic of, 08308
Contact: Jaejung Shim, M.D., Ph.D    +82-2-2626-1114    jaejshim@kumc.or.kr   
Sponsors and Collaborators
SamA Pharmaceutical Co., Ltd

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Responsible Party: SamA Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT03827590     History of Changes
Other Study ID Numbers: HLIM(SA16002)
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

Additional relevant MeSH terms:
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Infection
Respiratory Tract Infections
Bronchitis
Acute Disease
Respiratory Tract Diseases
Bronchial Diseases
Lung Diseases, Obstructive
Lung Diseases
Disease Attributes
Pathologic Processes