Status:
COMPLETED
Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "AG NPP709 Syrup"
Lead Sponsor:
Ahn-Gook Pharmaceuticals Co.,Ltd
Collaborating Sponsors:
Kyunghee University Medical Center
Inha University Hospital
Conditions:
Acute Upper Respiratory Tract Infections
Bronchitis
Eligibility:
All Genders
24-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess therapeutic confirmation of AG NPP709 syrup to evaluate the safety and efficacy in patients with acute upper respiratory tract infection and chronic inflammatory...
Eligibility Criteria
Inclusion
- Parent s or patient who decided to participate in this clinical trial at his (her) own will and agreed in written letter of consent
- Patient ages between 24months and 75years
- Patient with a clinical diagnosis of acute upper respiratory tract infection or chronic inflammatory bronchitis should has any combination of at least two of following symptoms including sputum: cough, sputum, dyspnea and chest pain when breathing
- Females of child-bearing age should have nagative pregnancy test or have sufficient contraceptive protection
Exclusion
- Patient whose the following severe respiratory disease: pneumonia, uncontrolled asthma, pancreatic fibrosis viral influenza, tuberculosis
- Patient whose the following disease: malignant tumors, severe central nervous system disorders, medication needed severe metabolic disorders
- Patient whose fructose intolerance
- Patient who has hypersensitivity anamnesis of Prospan syrup
- Patient whose heart function is abnormal: cardiac insufficiency, including the case of showing abnormal EKG test value that is clinically significant
- Patient whose liver or kidney function is serious abnormal: including the cases of ALT, AST, bilirubin and blood creatinine value exceeding three times of their upper limit, severe liver disorders, chronic kidney disease
- Patient who has uncontrolled diabetes or uncontrolled hypertensions
- Patient who has experience to have participated in other clinical trial within two months before starting the trial
- Pregnant women, lactating women
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
236 Patients enrolled
Trial Details
Trial ID
NCT01151202
Start Date
February 1 2010
End Date
June 1 2010
Last Update
October 5 2010
Active Locations (6)
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1
Inha University Hospital, Department of Pediatrics
Incheon, South Korea
2
Ewha Womens University Medical Center Mokdong Hospital, Department of Allergology
Seoul, South Korea
3
Hanyang University Medical Center, Department of Respiratory Medicine
Seoul, South Korea
4
Konkuk University Medical Center, Department of Respiratory Medicine
Seoul, South Korea