NCT Number: NCT01151202
Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "AG NPP709 Syrup"
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 bronchitis.
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Conditions
Age range
24 month–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Inha University Hospital, Department of Pediatrics, Incheon, South Korea
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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 criteria
- 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
Treatment and study plan
Primary outcomes
-
improvement by global assessment
Time frame: 5 days
At closing visit, researcher assess clinical efficacy using the following five criteria (4: cure, 3: significant improvement, 2: improvement, 1: some improvement, 0: non-improvement or worsening of symptoms). Upper the Grade 3 outcomes are defined as "clinical success".
Secondary outcomes
-
determine safety by unwanted reaction, clinical laboratory test and physical examination
Time frame: 5 days
Sponsors and collaborators
Lead sponsor
Ahn-Gook Pharmaceuticals Co.,Ltd
Industry
Collaborators
- Ewha Womans University
- Hanyang University
- Inha University Hospital
- Konkuk University Medical Center
- Kyunghee University Medical Center
Registry information
Official study title
Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "AG NPP709 Syrup" in Acute Upper Respiratory Tract Infection and Chronic Inflammatory Bronchitis Patients: Double Blinded, Randomized, Active Drug Comparative, Parallel Designed, Multi-centered, Phase III Study
Important dates
- Study start
- 2010
- Primary completion
- 2010
- Study completion
- 2010
- First posted
- Jun 28, 2010
- Registry last updated
- Oct 5, 2010
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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