Clinical trial NCT01151202: Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "AG NPP709 Syrup"
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Upper Respiratory Tract Infections
Bronchitis
Keywords: acute upper respiratory tract infection, chronic inflamatory bronchitis
Lead sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
Collaborators: name: Kyunghee University Medical Center
name: Inha University Hospital
name: Ewha Womans University
name: Hanyang University
name: Konkuk University Medical Center
First posted: 2010-06-28
Enrollment: 236
Sex: ALL
Minimum age (years): 24
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 bronchitis.


Eligibility criteria: Inclusion Criteria:

1. Parent s or patient who decided to participate in this clinical trial at his (her) own will and agreed in written letter of consent
2. Patient ages between 24months and 75years
3. 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
4. Females of child-bearing age should have nagative pregnancy test or have sufficient contraceptive protection

Exclusion Criteria:

1. Patient whose the following severe respiratory disease: pneumonia, uncontrolled asthma, pancreatic fibrosis viral influenza, tuberculosis
2. Patient whose the following disease: malignant tumors, severe central nervous system disorders, medication needed severe metabolic disorders
3. Patient whose fructose intolerance
4. Patient who has hypersensitivity anamnesis of Prospan syrup
5. Patient whose heart function is abnormal: cardiac insufficiency, including the case of showing abnormal EKG test value that is clinically significant
6. 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
7. Patient who has uncontrolled diabetes or uncontrolled hypertensions
8. Patient who has experience to have participated in other clinical trial within two months before starting the trial
9. Pregnant women, lactating women

Primary outcomes:
measure: improvement by global assessment
timeFrame: 5 days
Secondary outcomes:
measure: determine safety by unwanted reaction, clinical laboratory test and physical examination
timeFrame: 5 days
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital, Department of Pediatrics
city: Seoul
country: Korea, Republic of
facility: Ewha Womens University Medical Center Mokdong Hospital, Department of Allergology
city: Seoul
country: Korea, Republic of
facility: Hanyang University Medical Center, Department of Respiratory Medicine
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center, Department of Respiratory Medicine
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University International Medical Service, Department of Pediatrics
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Medical Center, Department of Pediatrics,
Study officials:
affiliation: Kyung Hee University Medical Center, Department of Pediatrics,
name: Young-ho Na, PhD, MD
role: STUDY_DIRECTOR
References: