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Phase III Study to Evaluate the Efficacy and Safety of HOB-048 CR Tab. in Comparison With HOB-048 Syrup in Patients With Cough Due to Acute or Chronic Bronchitis

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ClinicalTrials.gov Identifier: NCT03489837
Recruitment Status : Recruiting
First Posted : April 6, 2018
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Hyundai Pharm

Brief Summary:
A randomized, double-blind, multicenter, active-controlled phase III study to evaluate the efficacy and safety of Levotuss CR tab. in comparison with Levotuss syrup in patients with cough due to acute or chronic bronchitis

Condition or disease Intervention/treatment Phase
Evaluate the Efficacy and Safety of Levotuss CR Tab. in Comparison With Levotuss Syrup in Patients With Cough Due to Acute or Chronic Bronchitis Drug: Levotuss Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 272 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Multicenter, Active-controlled Phase III Study to Evaluate the Efficacy and Safety of Levotuss CR Tab. in Comparison With Levotuss Syrup in Patients With Cough Due to Acute or Chronic Bronchitis
Actual Study Start Date : January 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Levotuss CR tab
oral taken
Drug: Levotuss
oral taken

Active Comparator: Levotuss syrup
oral taken
Drug: Levotuss
oral taken




Primary Outcome Measures :
  1. Cough severity check [ Time Frame: 6 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • moderate, severe, very severe non-productive cough patients

Exclusion Criteria:

  • Patients receiving a concomitant therapy

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): NCT03489837


Locations
Korea, Republic of
Included Seoul national hospital,10sites Recruiting
Seoul, Korea, Republic of
Contact: Yujung NA Lee       20160026@hdpharm.co.kr   
Sponsors and Collaborators
Hyundai Pharm

Responsible Party: Hyundai Pharm
ClinicalTrials.gov Identifier: NCT03489837     History of Changes
Other Study ID Numbers: HOB-048
First Posted: April 6, 2018    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Cough
Bronchitis
Acute Disease
Bronchitis, Chronic
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Bronchial Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Dipropizine
Antitussive Agents
Respiratory System Agents