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

This study has been completed.
Sponsor:
Collaborators:
Kyunghee University Medical Center
Inha University Hospital
Ewha Womans University
Hanyang University
Konkuk University Medical Center
Information provided by:
Ahn-Gook Pharmaceuticals Co.,Ltd
ClinicalTrials.gov Identifier:
NCT01151202
First received: June 23, 2010
Last updated: October 3, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention Phase
Acute Upper Respiratory Tract Infections
Bronchitis
Drug: AG NPP709syrup
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Further study details as provided by Ahn-Gook Pharmaceuticals Co.,Ltd:

Primary Outcome Measures:
  • improvement by global assessment [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    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:
  • determine safety by unwanted reaction, clinical laboratory test and physical examination [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]

Enrollment: 236
Study Start Date: February 2010
Study Completion Date: June 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   24 Months to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01151202

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

No publications provided

Responsible Party: Jung Hoon, Han, Ahn-Gook Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT01151202     History of Changes
Other Study ID Numbers: AG NPP_P3
Study First Received: June 23, 2010
Last Updated: October 3, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Ahn-Gook Pharmaceuticals Co.,Ltd:
acute upper respiratory tract infection, chronic inflamatory bronchitis

Additional relevant MeSH terms:
Bronchitis
Acute Disease
Respiratory Tract Infections
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Disease Attributes
Pathologic Processes
Infection

ClinicalTrials.gov processed this record on July 29, 2014