Phase III Study to Evaluate the Efficacy and Safety of HO... | NCT03489837

Studies
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

NCT03489837

Sponsor

Hyundai Pharm

Status

Completed

Last Update Posted

Nov 20, 2018Actual

Enrollment

272Actual

Phase

Phase 3

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

Levotuss

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Nov 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2017Actual

Primary Completion Date

Oct 2018Actual

Completion Date

Oct 2018Actual

First Submitted Date

Mar 30, 2018

First Submission Date that Met QC Criteria

Mar 30, 2018

First Posted Date

Apr 6, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 19, 2018

Last Update Posted Date

Nov 20, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

272Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Levotuss CR tab	Experimental	oral taken	Drug: Levotuss
Levotuss syrup	Active Comparator	oral taken	Drug: Levotuss

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Levotuss	Drug	oral taken	Levotuss CR tab Levotuss syrup

Measure	Description	Time Frame
Cough severity check		6 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

moderate, severe, very severe non-productive cough patients

Exclusion Criteria:

Patients receiving a concomitant therapy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Included Seoul national hospital,10sites		Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D029481	Bronchitis, Chronic

Ancestor Terms

ID	Term
D001991	Bronchitis
D012141	Respiratory Tract Infections
D007239	Infections
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D029424	Pulmonary Disease, Chronic Obstructive
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms