Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-25 @ 7:48 PM
Study NCT ID:
NCT00739635
Status:
COMPLETED
Last Update Posted:
2016-02-04
First Post:
2008-08-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014012', 'term': 'Tinnitus'}], 'ancestors': [{'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 411}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-03', 'studyFirstSubmitDate': '2008-08-21', 'studyFirstSubmitQcDate': '2008-08-21', 'lastUpdatePostDateStruct': {'date': '2016-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TBF-12 (Tinnitus-Beeinträchtigungs-Fragebogen-12 "Tinnitus Handicap Inventory-12") total score change from baseline to end of treatment', 'timeFrame': 'Screening, Baseline, week 5, 13, 17'}], 'secondaryOutcomes': [{'measure': 'TBF-12 factorial scores, individual responder rate, Tinnitus Rating Scale, Sleep Questionnaire, population pharmacokinetics, optional pharmacogenetics', 'timeFrame': '17 weeks'}, {'measure': 'safety parameters', 'timeFrame': '17 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Subjective Tinnitus']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.merz.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the safety and efficacy of neramexane mesylate in the treatment of subjective tinnitus in comparison to placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients aged 18 to 75 years with a clinical diagnosis of first onset,\n* Persistent (i.e. tinnitus should never be absent for \\> 24 hours in a row), subjective, uni- or bilateral tinnitus present for at least 3 months but not more than 12 months\n\nExclusion Criteria:\n\n* Clinical diagnosis of intermittent or pulsatile tinnitus\n* Patients who have tinnitus as a concomitant symptom of an otological/neurological disease (such as otitis media, Menière's disease, otosclerosis, etc)"}, 'identificationModule': {'nctId': 'NCT00739635', 'acronym': 'EASE', 'briefTitle': 'Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merz Pharmaceuticals GmbH'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Clinical Evaluation of the Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus', 'orgStudyIdInfo': {'id': 'MRZ 92579/TI/3001'}, 'secondaryIdInfos': [{'id': 'EudraCT Number 2007-007835-16'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Neramexane mesylate']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Neramexane mesylate', 'type': 'DRUG', 'description': 'Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Double-blind treatment period of 17 weeks placebo', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'A-8020', 'city': 'Graz', 'country': 'Austria', 'facility': 'Krankenhaus der Elisabethinen', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': 'A-6330', 'city': 'Kufstein', 'country': 'Austria', 'facility': 'Bezirkskrankenhaus Kufstein', 'geoPoint': {'lat': 47.58333, 'lon': 12.16667}}, {'zip': 'A-4010', 'city': 'Linz', 'country': 'Austria', 'facility': 'A. ö. Krankenhaus der Elisabethinen Linz', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': 'A-5020', 'city': 'Salzburg', 'country': 'Austria', 'facility': 'Salzburger Landeskrankenhaus, Universitätsklinik für Hals-Nasen-Ohren-Krankheiten', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': 'A-1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Clin Pharm International GmbH, Zentrum Wien', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '06112', 'city': 'Halle', 'state': 'Saale', 'country': 'Germany', 'facility': 'Dr. Elisabeth Kühne', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': '52074', 'city': 'Aachen', 'country': 'Germany', 'facility': 'Dr. med. 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