Status:
COMPLETED
Clinical Trial to Evaluate the Safety and Efficacy of "Theobromine Capsule" as an Antitussive in Acute Cougher
Lead Sponsor:
Ahn-Gook Pharmaceuticals Co.,Ltd
Conditions:
Acute Bronchitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The aim of this clinical trial is to evaluate the antitussive effect of "Theobromine capsule 300mg" in patients with acute bronchitis.
Detailed Description
This study is double blinded, randomized, parallel designed, phase III clinical trial to evaluate the efficacy and safety of "Theobromine capsule 300mg" versus "Levodropropizine syrup" in patients wit...
Eligibility Criteria
Inclusion
- Patient who decided to participate in this clinical trial at his(her) own will and agreed in written letter of consent.
- Adult aged over 18
- Patient who has cough symptom caused by acute bronchitis
- Patient who go to see the doctor for severe cough at his(her) own will
- DCS score at screening vist sould be over 3.
- For fertile woman, HCG test at screening visit shloud be negative.
- patient who will continue to cough more than 1 week.(by physician's judgment)
Exclusion
- Patient who is accompanied by the seriously abnormal symptom in respiratory system, such as Acute infectious Pulmonary Disease, Tuberculosis, asthma.
- Chronic bronchitis including bronchial obstruction
- Patient who has clinical history of sensitivity to Xanthine drug.
- Patient who has Peptic Ulcer
- Patient whose liver or kidney function is seriously abnormal: Including the cases of sGOT, sGPT, bilirubin and blood creatinine value exceeding twice of their upper normal limit.
- Patient whose heart function is abnormal: including the case of showing abnormal EKG test value that is clinically significant.
- patient who has convulsion or alcoholism.
- Patient who has experience to have participated in other clinical trial within two months before starting the trial.
- Pregnant woman, lactating woman.
- Patient who thought to be cured within 3 days without any medicine.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
332 Patients enrolled
Trial Details
Trial ID
NCT01416480
Start Date
May 1 2010
End Date
May 1 2011
Last Update
August 15 2011
Active Locations (1)
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1
Hallym University Medical Center
Anyang-si, Gyeonggi-do, South Korea, 431-070