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

NCT01151202 | Completed Phase 3 DMC

• 1 other identifier: AG NPP_P3
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 6

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.

Conditions

Acute Upper Respiratory Tract Infections; Bronchitis

Keywords

acute upper respiratory tract infection, chronic inflamatory bronchitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  5 days

Study Arms (2)

AG NPP709 syrup

EXPERIMENTAL

AG NPP709 contains Ivy leaf extract and coptis rhizoma extract

Drug: AG NPP709syrup

Ivy leaf extract syrup

ACTIVE COMPARATOR

Drug: AG NPP709syrup

Interventions

AG NPP709syrup DRUG

AG NPP709 syrup; Ivy leaf extract syrup

Eligibility Criteria

• Age: 24 Months - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ahn-Gook Pharmaceuticals Co.,Ltd: lead
• Kyunghee University Medical Center: collaborator
• Inha University Hospital: collaborator
• Ewha Womans University: collaborator
• Hanyang University: collaborator
• Konkuk University Medical Center: collaborator

Study Sites (6)

Inha University Hospital, Department of Pediatrics

Incheon, South Korea

Location

Ewha Womens University Medical Center Mokdong Hospital, Department of Allergology

Seoul, South Korea

Location

Hanyang University Medical Center, Department of Respiratory Medicine

Seoul, South Korea

Location

Konkuk University Medical Center, Department of Respiratory Medicine

Seoul, South Korea

Location

Kyung Hee University International Medical Service, Department of Pediatrics

Seoul, South Korea

Location

Kyung Hee University Medical Center, Department of Pediatrics,

Seoul, South Korea

Location

MeSH Terms

Conditions

Bronchitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Young-ho Na, PhD, MD

  Kyung Hee University Medical Center, Department of Pediatrics,

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 23, 2010
• First Posted: June 28, 2010
• Study Start: February 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: June 1, 2010
• Last Updated: October 5, 2010

Record last verified: 2010-10

Locations

KR (6)