Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2026-01-01 @ 4:04 PM
Study NCT ID:
NCT00523120
Status:
TERMINATED
Last Update Posted:
2016-04-20
First Post:
2007-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topical Voltaren in Otitis Externa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010032', 'term': 'Otitis Externa'}], 'ancestors': [{'id': 'D010031', 'term': 'Otitis'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004008', 'term': 'Diclofenac'}], 'ancestors': [{'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-18', 'studyFirstSubmitDate': '2007-08-28', 'studyFirstSubmitQcDate': '2007-08-28', 'lastUpdatePostDateStruct': {'date': '2016-04-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'reducing oral analagestic use', 'timeFrame': '1 week'}], 'secondaryOutcomes': [{'measure': 'adding an alternative treatment for otitis externa', 'timeFrame': '1 week'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Otitis Externa']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ziv.org.il/', 'label': 'Sieff Medical Center'}]}, 'descriptionModule': {'briefSummary': 'Voltaren being a Non-steroidal anti-inflammatory drug (NSAID) drug may be used as a single drug therapy in otitis externa being both therapeutic and analgesic thus reducing consumption of oral analgesia.', 'detailedDescription': 'anticipated advantages are: reduction of inflammation and edema, no fungal overpopulation- when steroids are employed, contains boric acid as an ingredient, high safety profile, can be switched to antibiotic therapy later, can be used in conjunction wit steroids'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults having otitis externa as single diagnosis mild to moderate\n\nExclusion Criteria:\n\n* Diabetes\n* Children\n* Pregnant women\n* Immune compromise\n* Starting other treatment\n* Moderate to severe otitis externa'}, 'identificationModule': {'nctId': 'NCT00523120', 'briefTitle': 'Topical Voltaren in Otitis Externa', 'organization': {'class': 'OTHER', 'fullName': 'Sieff Medical Center'}, 'officialTitle': 'Topical Voltaren as an Alternative Treatment for Otitis Externa', 'orgStudyIdInfo': {'id': 'HP 7-264S'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'voltaren ophta', 'interventionNames': ['Drug: diclofenac sodium']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'dexotic', 'interventionNames': ['Drug: dexotc']}], 'interventions': [{'name': 'diclofenac sodium', 'type': 'DRUG', 'otherNames': ['voltaren ophta'], 'description': 'topical solution used in ear 5 drops 8 3/day', 'armGroupLabels': ['1']}, {'name': 'dexotc', 'type': 'DRUG', 'otherNames': ['dexotic'], 'description': 'aural drops', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13100', 'city': 'Safed', 'country': 'Israel', 'facility': 'Sieff Medical Center', 'geoPoint': {'lat': 32.96465, 'lon': 35.496}}], 'overallOfficials': [{'name': 'victor kizhner, m.d.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sieff Medical Center, Safed, ISRAEL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sieff Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Victor Kizhner MD', 'investigatorFullName': 'victor kizhner', 'investigatorAffiliation': 'Sieff Medical Center'}}}}