Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2026-02-25 @ 6:33 PM
Study NCT ID:
NCT04664803
Status:
TERMINATED
Last Update Posted:
2020-12-11
First Post:
2020-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Cefecin Tab. in Patients With Acute Sinusitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C047445', 'term': 'cefetamet pivoxyl'}, {'id': 'D000077525', 'term': 'Cefdinir'}], 'ancestors': [{'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 284}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2019-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-07', 'studyFirstSubmitDate': '2020-11-24', 'studyFirstSubmitQcDate': '2020-12-07', 'lastUpdatePostDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical effective rate', 'timeFrame': '21 days', 'description': 'Percentage of patients with clinical cure and improvement on days 14 and 21'}], 'secondaryOutcomes': [{'measure': 'Clinical cure rate', 'timeFrame': '21 days', 'description': 'Percentage of patients with clinical cure on days 14 and 21'}, {'measure': 'Clinical effective rate', 'timeFrame': '14 days', 'description': 'Percentage of patients with clinical cure and improvement on days 14'}, {'measure': 'Change from baseline in total score of clinical signs', 'timeFrame': '14 days', 'description': 'Evaluation of clinical signs through nasal endoscopy; purulent secretion from sinus ostia, pain over sinuses, facial swelling'}, {'measure': 'Change from baseline in total score of clinical signs', 'timeFrame': '21 days', 'description': 'Evaluation of clinical signs through nasal endoscopy; purulent secretion from sinus ostia, pain over sinuses, facial swelling'}]}, 'oversightModule': {'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Sinusitis']}, 'descriptionModule': {'briefSummary': 'This is a multi-center, double-blind, randomized, active controlled, parallel group phase 4 clinical trial to re-confirm the efficacy and safety of cefetamet pivoxil formulation in sinusitis patients', 'detailedDescription': 'Patients with acute sinusitis were randomly assigned (1:1) to receive either cefetamet (500 mg twice daily, study group) or cefdinir (100 mg three times a day, control group) and corresponding placebo t.i.d. or b.i.d. for 2 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with sinusitis (accompanied with otitis media) at screening, and whose first symptoms occurred within the past 3 weeks\n* Symptoms or signs of acute sinusitis persist without improvement for 10 days after onset or symptoms or signs of acute sinusitis initially improve and then worsen within 10 days\n\nExclusion Criteria:\n\n* Those who have a history of hypersensitivity to cephalosporin, penicillin, or other beta-lactam antibiotics\n* Those with a history of allergic rhinitis or other rhinitis\n* Those who have been diagnosed with sinusitis more than 3 times within a year\n* Have had or scheduled sinus surgery within 1 month\n* Creatinine Clearance \\< 40 mL/min at screening\n* Those whose AST, ALT, and total bilirubin are more than 3 times the upper limit of normal at screening\n* Cystic fibrosis patients'}, 'identificationModule': {'nctId': 'NCT04664803', 'acronym': 'CASIS', 'briefTitle': 'Safety and Efficacy of Cefecin Tab. in Patients With Acute Sinusitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Korea United Pharm. Inc.'}, 'officialTitle': 'A Clinical Trial to Re-confirm the Efficacy and the Safety of Cefetamet Pivoxil Formulation in Sinusitis Patients: Double Blinded, Randomized, Parallel Designed, Multi-center, Active Comparator Study (CASIS Study)', 'orgStudyIdInfo': {'id': 'KUP-CFC-401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cefecin Tab.', 'description': 'Cefecin Tab./Placebo to Omnicef Cap.', 'interventionNames': ['Drug: Cefecin Tab.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Omnicef Cap.', 'description': 'Omnicef Cap./Placebo to Cefecin Tab.', 'interventionNames': ['Drug: Omnicef Cap.']}], 'interventions': [{'name': 'Cefecin Tab.', 'type': 'DRUG', 'otherNames': ['cefetamet pivoxil'], 'armGroupLabels': ['Cefecin Tab.']}, {'name': 'Omnicef Cap.', 'type': 'DRUG', 'otherNames': ['cefdinir'], 'armGroupLabels': ['Omnicef Cap.']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea United Pharm. Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}