Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2025-12-31 @ 9:09 PM
Study NCT ID:
NCT02265393
Status:
COMPLETED
Last Update Posted:
2017-08-18
First Post:
2014-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A 1-Year Safety Study of OTO-104 in Subjects With Unilateral Meniere's Disease Located in United Kingdom
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-09-28', 'releaseDate': '2022-10-25'}], 'estimatedResultsFirstSubmitDate': '2022-10-25'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008575', 'term': 'Meniere Disease'}], 'ancestors': [{'id': 'D018159', 'term': 'Endolymphatic Hydrops'}, {'id': 'D007759', 'term': 'Labyrinth Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'dispFirstSubmitDate': '2017-08-16', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-16', 'studyFirstSubmitDate': '2014-10-09', 'dispFirstSubmitQcDate': '2017-08-16', 'studyFirstSubmitQcDate': '2014-10-09', 'dispFirstPostDateStruct': {'date': '2017-08-18', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2017-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety', 'timeFrame': 'Up to 1 Year', 'description': 'Otoscopy, audiometry, tympanometry, adverse events'}], 'secondaryOutcomes': [{'measure': "Meniere's Symptom Questionnaire", 'timeFrame': 'Up to 1 Year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ["Meniere's Disease"]}, 'descriptionModule': {'briefSummary': "This is a 2-part study of OTO-104 in subjects with unilateral Meniere's disease in the United Kingdom. The first part is a randomized, placebo-controlled study comparing the safety profile of 2 injections of OTO-104 or placebo spaced 3 months apart. The second part is an open-label extension where all subjects will receive an additional 2 intratympanic injections of OTO-104 spaced 3 months apart. Each subject will participate on the study for a total of 1 year."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria includes, but is not limited to:\n\n* Subject has a diagnosis of definite unilateral Meniere's disease.\n* Subject agrees to maintain their current standard of care treatments for Meniere's disease while on-study.\n\nExclusion Criteria includes, but is not limited to:\n\n* Subject is pregnant or lactating.\n* Subject has a history of immunodeficiency disease.\n* Subject has a history of previous endolymphatic sac surgery.\n* Subject has a history of previous use of intratympanic gentamicin in the affected ear.\n* Subject has a history of drop attacks.\n* Subject has experienced an adverse reaction to intratympanic injection of steroids."}, 'identificationModule': {'nctId': 'NCT02265393', 'briefTitle': "A 1-Year Safety Study of OTO-104 in Subjects With Unilateral Meniere's Disease Located in United Kingdom", 'organization': {'class': 'INDUSTRY', 'fullName': 'Otonomy, Inc.'}, 'officialTitle': "A 6-Month, Prospective, Randomized, Multicenter, Placebo-Controlled Safety Study of OTO-104 Given at 3-Month Intervals by Intratympanic Injection in Subjects With Unilateral Meniere's Disease Followed by a 6-Month Open-Label Extension", 'orgStudyIdInfo': {'id': '104-201403'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'OTO-104', 'description': '12 mg OTO-104 (dexamethasone)', 'interventionNames': ['Drug: OTO-104']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'OTO-104 vehicle', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'OTO-104', 'type': 'DRUG', 'armGroupLabels': ['OTO-104']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berkshire', 'country': 'United Kingdom', 'facility': 'Heatherwood & Wexham Park Hospitals'}, {'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Birmingham University Hospital', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'BMI The Edgbaston Hospital', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'Southmead Hospital Bristol', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'city': 'Bucks', 'country': 'United Kingdom', 'facility': 'Oxford University Hospitals'}, {'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Cambridge University Hospitals', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'city': 'Dorset', 'country': 'United Kingdom', 'facility': 'Dorset County Hospital'}, {'city': 'Gloucester', 'country': 'United Kingdom', 'facility': 'Gloucestershire Royal Hospital', 'geoPoint': {'lat': 51.86568, 'lon': -2.2431}}, {'city': 'Leicestershire', 'country': 'United Kingdom', 'facility': 'Leicester Royal Infirmary'}, {'city': 'London', 'country': 'United Kingdom', 'facility': "Guy's Hospital and St. Thomas' Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'St. George Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Norfolk', 'country': 'United Kingdom', 'facility': 'Norfolk & Norwich University Hospital'}, {'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'John Radcliffe Hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'city': 'Sheffield', 'country': 'United Kingdom', 'facility': "Sheffield Teaching Hospitals & Sheffield Children's Hospital", 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'city': 'Staffordshire', 'country': 'United Kingdom', 'facility': 'University Hospital of North Staffordshire, Stoke-on-Trent and Stafford General Hospital'}], 'overallOfficials': [{'name': 'Carl LeBel, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Otonomy, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Otonomy, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-10-25', 'type': 'RELEASE'}, {'date': '2023-09-28', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Otonomy, Inc.'}}}}