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

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

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.

Study Overview

• Status: Completed
• Conditions: Bronchitis; Acute Upper Respiratory Tract Infections
• Intervention / Treatment: Drug: AG NPP709syrup

• Study Type: Interventional
• Enrollment (Actual): 236
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of
    • Inha University Hospital, Department of Pediatrics
  • Seoul, Korea, Republic of
    • Ewha Womens University Medical Center Mokdong Hospital, Department of Allergology
  • Seoul, Korea, Republic of
    • Hanyang University Medical Center, Department of Respiratory Medicine
  • Seoul, Korea, Republic of
    • Konkuk University Medical Center, Department of Respiratory Medicine
  • Seoul, Korea, Republic of
    • Kyung Hee University International Medical Service, Department of Pediatrics
  • Seoul, Korea, Republic of
    • Kyung Hee University Medical Center, Department of Pediatrics,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AG NPP709 syrup; AG NPP709 contains Ivy leaf extract and coptis rhizoma extract	Drug: AG NPP709syrup
Active Comparator: Ivy leaf extract syrup	Drug: AG NPP709syrup

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
improvement by global assessment	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".	5 days

Secondary Outcome Measures

Outcome Measure	Time Frame
determine safety by unwanted reaction, clinical laboratory test and physical examination	5 days

Collaborators and Investigators

• Sponsor: Ahn-Gook Pharmaceuticals Co.,Ltd
• Collaborators: Hanyang University; Ewha Womans University; Konkuk University Medical Center; Kyunghee University Medical Center; Inha University Hospital
• Investigators: Study Director: Young-ho Na, PhD, MD, Kyung Hee University Medical Center, Department of Pediatrics,

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: June 23, 2010
• First Submitted That Met QC Criteria: June 24, 2010
• First Posted (Estimate): June 28, 2010

Study Record Updates

• Last Update Posted (Estimate): October 5, 2010
• Last Update Submitted That Met QC Criteria: October 3, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: acute upper respiratory tract infection, chronic inflamatory bronchitis
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Infections; Respiratory Tract Infections; Bronchitis
• Other Study ID Numbers: AG NPP_P3