Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT01071902
Status:
TERMINATED
Last Update Posted:
2012-12-03
First Post:
2010-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Moxidex Otic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010033', 'term': 'Otitis Media'}, {'id': 'D010031', 'term': 'Otitis'}], 'ancestors': [{'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic 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': 400}}, 'statusModule': {'whyStopped': 'Management decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'dispFirstSubmitDate': '2012-11-28', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-29', 'studyFirstSubmitDate': '2010-02-18', 'dispFirstSubmitQcDate': '2012-11-28', 'studyFirstSubmitQcDate': '2010-02-18', 'dispFirstPostDateStruct': {'date': '2012-11-30', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Cure at End of Treatment', 'timeFrame': 'Day 8'}], 'secondaryOutcomes': [{'measure': 'Time to Cessation of Otorrhea', 'timeFrame': 'From First Dose'}, {'measure': 'Microbiological Success at End of Treatment', 'timeFrame': 'Day 8'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ear tubes', 'ear drainage', 'ear infection', 'ear drops', 'acute otitis media'], 'conditions': ['Acute Otitis Media']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if Moxidex otic solution is safe and effective in treating middle ear infections in patients with ear tubes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 6 months to 12 years of age\n* Ear tubes in one or both ears\n* Ear drainage visible by parent/guardian\n* Ear drainage less than 21 days\n* Other protocol-defined inclusion criteria may apply\n\nExclusion Criteria:\n\n* Patients not otorrhea-free for 7 or less following tympanostomy tube surgery\n* Ear tube with antimicrobial activity; ear tube longer than 2.5mm\n* Non-tube otorrhea\n* No otic surgery other than tube placement in the last year\n* No menarchial females; no diabetic patients\n* No patients with any disease or condition that would negatively affect the conduct of the study\n* No patients taking any other systemic antimicrobial therapy during the study\n* Patient must meet certain medication washouts to be eligible\n* Analgesic use (other than acetaminophen) is not allowed\n* Patients may not be predisposed to neurosensory hearing loss\n* Other protocol-defined exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01071902', 'briefTitle': 'Safety and Efficacy of Moxidex Otic', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Safety and Efficacy Evaluation of Topical Moxidex Otic Solution in the Treatment of Acute Otitis Media With Otorrhea in Tympanostomy Tubes', 'orgStudyIdInfo': {'id': 'C-09-033'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Moxidex', 'description': 'Moxidex otic solution', 'interventionNames': ['Drug: Moxidex otic solution', 'Device: Tympanostomy tubes']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Moxifloxacin', 'description': 'Moxifloxacin otic solution', 'interventionNames': ['Drug: Moxifloxacin otic solution', 'Device: Tympanostomy tubes']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vehicle', 'description': 'Vehicle', 'interventionNames': ['Other: Vehicle', 'Device: Tympanostomy tubes']}], 'interventions': [{'name': 'Moxidex otic solution', 'type': 'DRUG', 'description': '4 drops into the infected ear(s) twice daily (morning and evening) for 7 days', 'armGroupLabels': ['Moxidex']}, {'name': 'Moxifloxacin otic solution', 'type': 'DRUG', 'description': '4 drops into the infected ear(s) twice daily (morning and evening) for 7 days', 'armGroupLabels': ['Moxifloxacin']}, {'name': 'Vehicle', 'type': 'OTHER', 'description': '4 drops into the infected ear(s) twice daily (morning and evening) for 7 days', 'armGroupLabels': ['Vehicle']}, {'name': 'Tympanostomy tubes', 'type': 'DEVICE', 'description': 'Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children', 'armGroupLabels': ['Moxidex', 'Moxifloxacin', 'Vehicle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76134', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Contact Alcon Call Center for Trial Locations', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}], 'overallOfficials': [{'name': 'Contact Alcon Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': '1-888-451-3937'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}