Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT01151202
Status:
COMPLETED
Last Update Posted:
2010-10-05
First Post:
2010-06-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "AG NPP709 Syrup"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001991', 'term': 'Bronchitis'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 236}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-03', 'studyFirstSubmitDate': '2010-06-23', 'studyFirstSubmitQcDate': '2010-06-24', 'lastUpdatePostDateStruct': {'date': '2010-10-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'improvement by global assessment', 'timeFrame': '5 days', '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".'}], 'secondaryOutcomes': [{'measure': 'determine safety by unwanted reaction, clinical laboratory test and physical examination', 'timeFrame': '5 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['acute upper respiratory tract infection, chronic inflamatory bronchitis'], 'conditions': ['Acute Upper Respiratory Tract Infections', 'Bronchitis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '24 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Parent s or patient who decided to participate in this clinical trial at his (her) own will and agreed in written letter of consent\n2. Patient ages between 24months and 75years\n3. 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\n4. Females of child-bearing age should have nagative pregnancy test or have sufficient contraceptive protection\n\nExclusion Criteria:\n\n1. Patient whose the following severe respiratory disease: pneumonia, uncontrolled asthma, pancreatic fibrosis viral influenza, tuberculosis\n2. Patient whose the following disease: malignant tumors, severe central nervous system disorders, medication needed severe metabolic disorders\n3. Patient whose fructose intolerance\n4. Patient who has hypersensitivity anamnesis of Prospan syrup\n5. Patient whose heart function is abnormal: cardiac insufficiency, including the case of showing abnormal EKG test value that is clinically significant\n6. 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\n7. Patient who has uncontrolled diabetes or uncontrolled hypertensions\n8. Patient who has experience to have participated in other clinical trial within two months before starting the trial\n9. Pregnant women, lactating women'}, 'identificationModule': {'nctId': 'NCT01151202', 'briefTitle': 'Therapeutic Confirmatory Clinical Trial to Evaluate the Safety and Efficacy of "AG NPP709 Syrup"', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ahn-Gook Pharmaceuticals Co.,Ltd'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'AG NPP_P3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AG NPP709 syrup', 'description': 'AG NPP709 contains Ivy leaf extract and coptis rhizoma extract', 'interventionNames': ['Drug: AG NPP709syrup']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ivy leaf extract syrup', 'interventionNames': ['Drug: AG NPP709syrup']}], 'interventions': [{'name': 'AG NPP709syrup', 'type': 'DRUG', 'armGroupLabels': ['AG NPP709 syrup', 'Ivy leaf extract syrup']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Incheon', 'country': 'South Korea', 'facility': 'Inha University Hospital, Department of Pediatrics', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Ewha Womens University Medical Center Mokdong Hospital, Department of Allergology', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Hanyang University Medical Center, Department of Respiratory Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Konkuk University Medical Center, Department of Respiratory Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kyung Hee University International Medical Service, Department of Pediatrics', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kyung Hee University Medical Center, Department of Pediatrics,', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Young-ho Na, PhD, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kyung Hee University Medical Center, Department of Pediatrics,'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ahn-Gook Pharmaceuticals Co.,Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Kyunghee University Medical Center', 'class': 'OTHER'}, {'name': 'Inha University Hospital', 'class': 'OTHER'}, {'name': 'Ewha Womans University', 'class': 'OTHER'}, {'name': 'Hanyang University', 'class': 'OTHER'}, {'name': 'Konkuk University Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Jung Hoon, Han', 'oldOrganization': 'Ahn-Gook Pharmaceutical Co., Ltd'}}}}