Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Trials to Assess the Efficacy and Safety of HLIM

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE January 10, 2019
First Posted Date  ICMJE February 1, 2019
Last Update Posted Date February 8, 2019
Actual Study Start Date  ICMJE November 29, 2018
Estimated Primary Completion Date May 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2019)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03827590 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trials to Assess the Efficacy and Safety of HLIM
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Upper Respiratory Tract Infection
  • Acute Bronchitis
Intervention  ICMJE
  • Drug: Test
    three times a day for five days
    Other Name: HLIM+SA160021 Placebo+SA160022 Placebo
  • Drug: Active Comparator Control 1
    three times a day for five days
    Other Name: HLIM Placebo+SA160021+SA160022 Placebo
  • Drug: Active Comparator Control 2
    three times a day for five days
    Other Name: HLIM Placebo+SA160021 Placebo+SA160022
  • Drug: Placebo
    three times a day for five days
    Other Name: HLIM Placebo+SA160021 Placebo+SA160022 Placebo
Study Arms  ICMJE
  • Experimental: HLIM
    HLIM+SA160021 Placebo+SA160022 Placebo
    Intervention: Drug: Test
  • Active Comparator: SA160021
    HLIM Placebo+SA160021+SA160022 Placebo
    Intervention: Drug: Active Comparator Control 1
  • Active Comparator: SA160022
    HLIM Placebo+SA160021 Placebo+SA160022
    Intervention: Drug: Active Comparator Control 2
  • Placebo Comparator: Placebo
    HLIM Placebo+SA160021 Placebo+SA160022 Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 31, 2019)
487
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2019
Estimated Primary Completion Date May 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03827590
Other Study ID Numbers  ICMJE HLIM(SA16002)
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party SamA Pharmaceutical Co., Ltd
Study Sponsor  ICMJE SamA Pharmaceutical Co., Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account SamA Pharmaceutical Co., Ltd
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP