Evaluate the Efficacy and Safety of Levotuss CR Tab. in Comparison With Levotuss Syrup in Patients With Cough Due to Acute or Chronic Bronchitis Clinical Trial
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
| NCT number | NCT03489837 |
| Other study ID # | HOB-048 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | |
| Last updated | |
| Start date | January 2017 |
| Est. completion date | October 2018 |
| Verified date | November 2018 |
| Source | Hyundai Pharm |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 272 |
| Est. completion date | October 2018 |
| Est. primary completion date | October 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 19 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - moderate, severe, very severe non-productive cough patients Exclusion Criteria: - Patients receiving a concomitant therapy |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Included Seoul national hospital,10sites | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Hyundai Pharm |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cough severity check | 6 hours |