NCT03489837

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
272

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 6, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

November 20, 2018

Status Verified

November 1, 2018

Enrollment Period

1.7 years

First QC Date

March 30, 2018

Last Update Submit

November 19, 2018

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

Outcome Measures

Primary Outcomes (1)

  • Cough severity check

    6 hours

Study Arms (2)

Levotuss CR tab

EXPERIMENTAL

oral taken

Drug: Levotuss

Levotuss syrup

ACTIVE COMPARATOR

oral taken

Drug: Levotuss

Interventions

LevotussDRUG

oral taken

Levotuss CR tabLevotuss syrup

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients receiving a concomitant therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Included Seoul national hospital,10sites

Seoul, South Korea

Location

MeSH Terms

Conditions

Bronchitis, Chronic

Interventions

dipropizine

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesPulmonary Disease, Chronic ObstructiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2018

First Posted

April 6, 2018

Study Start

January 1, 2017

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

November 20, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will share

Locations

KR(1)