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CompletedNCT03489837Updated Nov 20, 2018

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

A Phase 3 interventional study of Levotuss in Evaluate the Efficacy and Safety of Levotuss CR Tab. in Comparison With Levotuss Syrup in Patients With Cough Due to Acute or Chronic Bronchitis, sponsored by Hyundai Pharm. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-20.

Sponsored by Hyundai Pharm · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Jan 2017, registered Mar 2018).
Phase
Phase 3
Study type
Interventional
Enrollment
272
Allocation
Randomized
Ages
19 Years to 75 Years
Sex
All
01

Study 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

02

Conditions studied

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

Browse trials for

03

In context

Bronchitis, Chronic

209 studies on the registry are indexed under Bronchitis, Chronic; 14 are open to participants now.

This study's enrollment of 272 is above the median of 101 across 154 interventional studies indexed under Bronchitis, Chronic.

Browse Bronchitis, Chronic studies →

Lead sponsor

Hyundai Pharm is the lead sponsor of 7 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients receiving a concomitant therapy
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
272 participants (actual)

Study arms

  • Experimental
    Levotuss CR tab

    oral taken

    Drug: Levotuss

  • Active comparator
    Levotuss syrup

    oral taken

    Drug: Levotuss

Interventions

06

What researchers measure

Primary outcomes

  1. Cough severity check

    Time frame: 6 hours

07

Study locations

1 site
  • Included Seoul national hospital,10sites
    Seoul, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2017 to primary completion in Oct 2018, 21 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 30, 2018
First posted
Apr 6, 2018
StartActual
Jan 2017
Primary completionActual
Oct 2018
CompletionActual
Oct 2018
Last update
Nov 20, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03489837
Lead sponsor
Hyundai Pharm
Responsible party
Sponsor
First posted
Apr 6, 2018
Start date
Jan 2017
Primary completion
Oct 2018
Completion
Oct 2018
Last update
Nov 20, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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