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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01151202
Recruitment Status : Completed
First Posted : June 28, 2010
Last Update Posted : October 5, 2010
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

Tracking Information
First Submitted Date  ICMJE June 23, 2010
First Posted Date  ICMJE June 28, 2010
Last Update Posted Date October 5, 2010
Study Start Date  ICMJE February 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 24, 2010)
improvement by global assessment [ Time Frame: 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".
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01151202 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2010)
determine safety by unwanted reaction, clinical laboratory test and physical examination [ Time Frame: 5 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "AG NPP709 Syrup"
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Upper Respiratory Tract Infections
  • Bronchitis
Intervention  ICMJE Drug: AG NPP709syrup
Study Arms  ICMJE
  • Experimental: AG NPP709 syrup
    AG NPP709 contains Ivy leaf extract and coptis rhizoma extract
    Intervention: Drug: AG NPP709syrup
  • Active Comparator: Ivy leaf extract syrup
    Intervention: Drug: AG NPP709syrup
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 24, 2010)
236
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 24 Months to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01151202
Other Study ID Numbers  ICMJE AG NPP_P3
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jung Hoon, Han, Ahn-Gook Pharmaceutical Co., Ltd
Study Sponsor  ICMJE Ahn-Gook Pharmaceuticals Co.,Ltd
Collaborators  ICMJE
  • Kyunghee University Medical Center
  • Inha University Hospital
  • Ewha Womans University
  • Hanyang University
  • Konkuk University Medical Center
Investigators  ICMJE
Study Director: Young-ho Na, PhD, MD Kyung Hee University Medical Center, Department of Pediatrics,
PRS Account Ahn-Gook Pharmaceuticals Co.,Ltd
Verification Date October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP