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

Phase 3

Completed

• Conditions: Evaluate the Efficacy and Safety of Levotuss CR Tab. in Comparison With Levotuss Syrup in Patients With Cough Due to Acute or Chronic Bronchitis
• Interventions: Drug: Levotuss

• Registration Number: NCT03489837
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2018-03-30
• Study First Submitted QC: 2018-03-30
• Study First Posted: 2018-04-06
• Primary Completion: 2018-10
• Study Completion: 2018-10
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-19
• Last Update Posted: 2018-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 272

Inclusion Criteria

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

Exclusion Criteria

• Patients receiving a concomitant therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levotuss syrup	Levotuss	oral taken
Levotuss CR tab	Levotuss	oral taken

Primary Outcome Measures

Name	Time	Method
Cough severity check	6 hours

Trial Locations

Locations (1)

Included Seoul national hospital,10sites; 🇰🇷 Seoul, Korea, Republic of