Status:
COMPLETED
Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of AG1321001 in Chronic Cougher
Lead Sponsor:
Ahn-Gook Pharmaceuticals Co.,Ltd
Conditions:
Cough
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
This study is for therapeutic confirmation of AG1321001 to evaluate the safety and efficacy as an anti-tussive agent in cough patients.
Eligibility Criteria
Inclusion
- Adult between the ages of 18 and 70.
- Patient who has cough symptom caused by following diseases: chronic bronchitis, bronchiectasis, gastroesophageal reflux disease, postnasal drip syndrome caused by rhinitis, sinusitis, rhinopharyngitis, rhinolaryngitis.
- Patient requiring internal treatment due to cough symptom, who has coughing more than 3 weeks.
- patient who will continue to cough more than 1 week.(by physician's judgment)
- Patient who decided to participate in this clinical trial at his(her) own will and agreed in written letter of consent.
- Patient who is trustworthy, ready for cooperation and observing the restrictions during the trial period.
Exclusion
- Patient who is accompanied by the seriously abnormal symptom in respiratory system, such as Acute infectious Pulmonary Disease, Tuberculosis.
- Patient who has clinical history of sensitivity to Xanthine drug.
- Patient who has Peptic Ulcer or Asthma (Except Cicatrix)
- 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 experience to have participated in other clinical trial within two months before starting the trial.
- Pregnant woman, lactating woman.
- patient who has convulsion or alcoholism.
- patient who take medicines which can not use combination with AG1321001.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
396 Patients enrolled
Trial Details
Trial ID
NCT00380315
Start Date
March 1 2006
End Date
June 1 2007
Last Update
July 2 2009
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 82