Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2026-04-15 @ 6:43 AM
Study NCT ID:
NCT02151734
Status:
COMPLETED
Last Update Posted:
2014-05-30
First Post:
2014-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of KALOMIN™ Tab. in Patients With Acute Bronchitis
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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 242}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'lastUpdateSubmitDate': '2014-05-28', 'studyFirstSubmitDate': '2014-05-28', 'studyFirstSubmitQcDate': '2014-05-28', 'lastUpdatePostDateStruct': {'date': '2014-05-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total score of BSS(Bronchitis Severity Score)', 'timeFrame': '7days'}], 'secondaryOutcomes': [{'measure': 'Individual symptom score of BSS', 'timeFrame': '7days'}, {'measure': 'reaction rate of treatment', 'timeFrame': '7days'}, {'measure': 'IMOS(Integrative Medicine Outcome Scale)', 'timeFrame': '7days'}, {'measure': 'IMPSS(Integrative Medicine Patient Satisfaction Scale)', 'timeFrame': '7days'}, {'measure': 'Adverse events, clinical laboratory examination, physical examination, etc.', 'timeFrame': '7 days'}]}, 'conditionsModule': {'conditions': ['Acute Bronchitis']}, 'descriptionModule': {'briefSummary': 'This is a multi-center, double-dummy, double-blind, randomized, active-controlled, parallel group phase 3 clinical trial to evaluate the efficacy and safety of KALOMIN™ Tab. in patients with acute bronchitis.\n\nThe aim of this clinical trial is to demonstrate that KALOMIN™ Tab. is clinically non-inferior to Umckamin syrup, as assessed by BSS(Bronchitis Severity Score), in the treatment of acute bronchitis after 7 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients aged 12-75 years old\n* A total score of BSS ≥ 5\n* The duration of symptoms had to be less than 14 days and no chronic pulmonary disease\n* Patients who voluntarily sign a written informed consent to participate in the trial\n\nExclusion Criteria:\n\n* Indication for antibiotic treatment(e.g. severe respiratory infection)\n* Allergic bronchial asthma\n* Tendency to bleed\n* Severe heart, renal, or liver diseases or decline of immune function\n* Chronic obstructive pulmonary disease\n* Known or supposed hypersensitivity to investigational medication\n* Treatment with antibiotics during the past 4 weeks prior to inclusion in the trial\n* Women during pregnancy or lactation period\n* Clinically significant abnormal values in the screening test(more than twice the upper limit of normal range for ALT, AST, BUN, and Serum Creatinine)\n* Participation in any other trial within 30 days prior to inclusion in the trial\n* Unsuitable patients for enrollment in the opinion of the investigator'}, 'identificationModule': {'nctId': 'NCT02151734', 'briefTitle': 'Safety and Efficacy of KALOMIN™ Tab. in Patients With Acute Bronchitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Korea United Pharm. Inc.'}, 'orgStudyIdInfo': {'id': 'KUP-KLM_301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KALOMIN™ Tab.', 'description': 'KALOMIN™ Tab./Placebo to Umckamin syrup', 'interventionNames': ['Drug: KALOMIN™ Tab.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Umckamin syrup', 'description': 'Umckamin syrup/Placebo to KALOMIN™ Tab.', 'interventionNames': ['Drug: Umckamin syrup']}], 'interventions': [{'name': 'KALOMIN™ Tab.', 'type': 'DRUG', 'armGroupLabels': ['KALOMIN™ Tab.']}, {'name': 'Umckamin syrup', 'type': 'DRUG', 'armGroupLabels': ['Umckamin syrup']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea United Pharm. Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}