Evaluate the Efficacy and Safety of Levotuss CR Tab. in Comparison With Levotuss Syrup in Patients With Cough Due to Acute or Chronic BronchitisPhase 3NCT03489837
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 study testing Levotuss in people with Evaluate the Efficacy and Safety of Levotuss CR Tab. in Comparison With Levotuss Syrup in Patients With Cough Due to Acute or Chronic Bronchitis, run by Hyundai Pharm at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 19 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Evaluate the Efficacy and Safety of Levotuss CR Tab. in Comparison With Levotuss Syrup in Patients With Cough Due to Acute or Chronic Bronchitis
- What is being tested?
- Levotuss
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2017to Oct 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- moderate, severe, very severe non-productive cough patients
Who cannot join
- Patients receiving a concomitant therapy
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Levotuss
- Medical subject headings
- Bronchitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevotussDrug
oral taken
| Study group | Role | What they receive |
|---|---|---|
| Levotuss CR tab | Experimental | oral taken Receives: Drug: Levotuss |
| Levotuss syrup | Active comparator | oral taken Receives: Drug: Levotuss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cough severity check
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study startJan 2017
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluate the Efficacy and Safety of Levotuss CR Tab. in Comparison With Levotuss Syrup in Patients With Cough Due to Acute or Chronic BronchitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hyundai Pharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489837
- Sponsor's protocol ID
- HOB-048
- Status last verified
- Nov 2018
- First submitted
- 30 Mar 2018
- Last updated
- 20 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03489837
- Acronym / sponsor ID
- HOB-048
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Hyundai PharmIndustry (pharma, biotech, devices)
- Study start
- Jan 2017 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 6 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levotuss CR tab | Experimental | Drug: Levotussoral taken |
| Levotuss syrup | Active comparator | Drug: Levotussoral taken |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- moderate, severe, very severe non-productive cough patients
Key exclusion criteria (1 listed)
- Patients receiving a concomitant therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levotussoral taken | Drug | Levotuss CR tab, Levotuss syrup |
Primary outcome
Cough severity check
Time frame: 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levotuss in people with Evaluate the Efficacy and Safety of Levotuss CR Tab. in Comparison With Levotuss Syrup in Patients With Cough Due to Acute or Chronic Bronchitis, run by Hyundai Pharm at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cough severity check (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2018.