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

Bronchitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01151202
• Other study ID #: AG NPP_P3
• Status: Completed
• Phase: Phase 3
• First received: June 23, 2010
• Last updated: October 3, 2010
• Start date: February 2010
• Est. completion date: June 2010

Study information

• Verified date: October 2010
• Source: Ahn-Gook Pharmaceuticals Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: June 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 24 Months to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Acute Upper Respiratory Tract Infections
• Bronchitis
• Infection
• Respiratory Tract Infections

Intervention

Drug:
• AG NPP709syrup

Locations

Country	Name	City	State
Korea, Republic of	Inha University Hospital, Department of Pediatrics	Incheon
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,	Seoul

Sponsors (6)

Lead Sponsor	Collaborator
Ahn-Gook Pharmaceuticals Co.,Ltd	Ewha Womans University, Hanyang University, Inha University Hospital, Konkuk University Medical Center, Kyunghee University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	determine safety by unwanted reaction, clinical laboratory test and physical examination		5 days	Yes