Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "AG NPP709 Syrup"

Phase 3

Completed

• Conditions: Acute Upper Respiratory Tract Infections; Bronchitis
• Interventions: Drug: AG NPP709syrup

• Registration Number: NCT01151202
• Lead Sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2010-05
• Study Completion: 2010-06
• Study First Submitted: 2010-06-23
• Study First Submitted QC: 2010-06-24
• Study First Posted: 2010-06-28
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-03
• Last Update Posted: 2010-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 236

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AG NPP709 syrup	AG NPP709syrup	AG NPP709 contains Ivy leaf extract and coptis rhizoma extract
Ivy leaf extract syrup	AG NPP709syrup	-

Primary Outcome Measures

Name	Time	Method
improvement by global assessment	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 Outcome Measures

Name	Time	Method
determine safety by unwanted reaction, clinical laboratory test and physical examination	5 days

Trial Locations

Locations (6)

Hanyang University Medical Center, Department of Respiratory Medicine; 🇰🇷 Seoul, Korea, Republic of

Inha University Hospital, Department of Pediatrics; 🇰🇷 Incheon, Korea, Republic of

Kyung Hee University International Medical Service, Department of Pediatrics; 🇰🇷 Seoul, Korea, Republic of

Ewha Womens University Medical Center Mokdong Hospital, Department of Allergology; 🇰🇷 Seoul, Korea, Republic of

Kyung Hee University Medical Center, Department of Pediatrics,; 🇰🇷 Seoul, Korea, Republic of

Konkuk University Medical Center, Department of Respiratory Medicine; 🇰🇷 Seoul, Korea, Republic of