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Clinical Trials to Assess the Efficacy and Safety of HLIM

Sponsor
SamA Pharmaceutical Co., Ltd (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03827590
Collaborator
(none)
487
Enrollment
1
Location
4
Arms
11
Anticipated Duration (Months)
44.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Nov 29, 2018
Anticipated Primary Completion Date :
May 30, 2019
Anticipated Study Completion Date :
Oct 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: HLIM

HLIM+SA160021 Placebo+SA160022 Placebo

Drug: Test
three times a day for five days
Other Names:
  • 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 Names:
  • 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 Names:
  • HLIM Placebo+SA160021 Placebo+SA160022

    		•
    Placebo Comparator: Placebo

    HLIM Placebo+SA160021 Placebo+SA160022 Placebo

    Drug: Placebo
    three times a day for five days
    Other Names:
  • HLIM Placebo+SA160021 Placebo+SA160022 Placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Changes in BSS(Bronchitis Severity Score)-cough domain of active comparator control 2 versus placebo [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 [5 days]

      0(absent) ~ 4(very severe), Total Score: 0~20

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Korea University Guro Hospital Seoul Guro-gu Korea, Republic of 08308

    Sponsors and Collaborators

    • SamA Pharmaceutical Co., Ltd

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    SamA Pharmaceutical Co., Ltd
    ClinicalTrials.gov Identifier:
    NCT03827590
    Other Study ID Numbers:
    • HLIM(SA16002)
    First Posted:
    Feb 1, 2019
    Last Update Posted:
    Feb 8, 2019
    Last Verified:
    Feb 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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:
    Infections
    Respiratory Tract Infections
    Bronchitis

    Study Results

    No Results Posted as of Feb 8, 2019