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

Primary Purpose

Acute Upper Respiratory Tract Infections, Bronchitis

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
AG NPP709syrup
Sponsored by
Ahn-Gook Pharmaceuticals Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Upper Respiratory Tract Infections focused on measuring acute upper respiratory tract infection, chronic inflamatory bronchitis

Eligibility Criteria

24 Months - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AG NPP709 syrup

Ivy leaf extract syrup

Arm Description

AG NPP709 contains Ivy leaf extract and coptis rhizoma extract

Outcomes

Primary Outcome Measures

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".

Secondary Outcome Measures

determine safety by unwanted reaction, clinical laboratory test and physical examination

Full Information

First Posted
June 23, 2010
Last Updated
October 3, 2010
Sponsor
Ahn-Gook Pharmaceuticals Co.,Ltd
Collaborators
Kyunghee University Medical Center, Inha University Hospital, Ewha Womans University, Hanyang University, Konkuk University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01151202
Brief Title
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

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ahn-Gook Pharmaceuticals Co.,Ltd
Collaborators
Kyunghee University Medical Center, Inha University Hospital, Ewha Womans University, Hanyang University, Konkuk University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Upper Respiratory Tract Infections, Bronchitis
Keywords
acute upper respiratory tract infection, chronic inflamatory bronchitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
236 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AG NPP709 syrup
Arm Type
Experimental
Arm Description
AG NPP709 contains Ivy leaf extract and coptis rhizoma extract
Arm Title
Ivy leaf extract syrup
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
AG NPP709syrup
Primary Outcome Measure Information:
Title
improvement by global assessment
Description
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".
Time Frame
5 days
Secondary Outcome Measure Information:
Title
determine safety by unwanted reaction, clinical laboratory test and physical examination
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young-ho Na, PhD, MD
Organizational Affiliation
Kyung Hee University Medical Center, Department of Pediatrics,
Official's Role
Study Director
Facility Information:
Facility Name
Inha University Hospital, Department of Pediatrics
City
Incheon
Country
Korea, Republic of
Facility Name
Ewha Womens University Medical Center Mokdong Hospital, Department of Allergology
City
Seoul
Country
Korea, Republic of
Facility Name
Hanyang University Medical Center, Department of Respiratory Medicine
City
Seoul
Country
Korea, Republic of
Facility Name
Konkuk University Medical Center, Department of Respiratory Medicine
City
Seoul
Country
Korea, Republic of
Facility Name
Kyung Hee University International Medical Service, Department of Pediatrics
City
Seoul
Country
Korea, Republic of
Facility Name
Kyung Hee University Medical Center, Department of Pediatrics,
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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