Clinical Trials to Assess the Efficacy and Safety of HLIM

February 7, 2019 updated by: SamA Pharmaceutical Co., Ltd

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

487

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Guro-gu
      • Seoul, Guro-gu, Korea, Republic of, 08308
        • Recruiting
        • Korea University Guro Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 75 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 days
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
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SamA Pharmaceutical Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 29, 2018

Primary Completion (ANTICIPATED)

May 30, 2019

Study Completion (ANTICIPATED)

October 31, 2019

Study Registration Dates

First Submitted

January 10, 2019

First Submitted That Met QC Criteria

January 31, 2019

First Posted (ACTUAL)

February 1, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2019

Last Update Submitted That Met QC Criteria

February 7, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HLIM(SA16002)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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