[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100504682":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":24,"centralContacts":27,"locations":36,"responsibleParty":55,"collaborators":59,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":24,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":39,"whyStopped":24,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Leiden University Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Methylprednisolon","ACTIVE_COMPARATOR","Intratympanal injection with Methylprednisolon 62.5 mg\u002F ml",[13],"Drug: Methylprednisolon",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Intratympanal injection with saline, natriumchloride 0.9%",[19],"Drug: Placebo",[21,25],{"type":22,"name":9,"description":11,"armGroupLabels":23,"otherNames":24},"DRUG",[9],null,{"type":22,"name":15,"description":17,"armGroupLabels":26,"otherNames":24},[15],[28,33],{"name":29,"role":30,"phone":31,"phoneExt":24,"email":32},"Maud Boreel, MD","CONTACT","+3171 526 9111","m.m.e.boreel@lumc.nl",{"name":34,"role":30,"phone":31,"phoneExt":24,"email":35},"Babette van Esch, MD, PHD","b.f.van_esch@lumc.nl",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Leiden University Medical Centre","RECRUITING","Leiden","South Holland","2300RC","Netherlands","NL",{"type":46,"coordinates":47},"Point",[48,49],4.49306,52.15833,{"lat":49,"lon":48},[52],{"name":53,"role":30,"phone":54,"phoneExt":24,"email":32},"Maud Boreel, Msc","+31647682120",{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Babette F van Esch, MD, PhD","dr. van Esch, MD, PHD",[60,62,64,66,68,70],{"name":61,"class":6},"ZonMw: The Netherlands Organisation for Health Research and Development",{"name":63,"class":6},"Gelre Hospitals",{"name":65,"class":6},"Maasstad Hospital",{"name":67,"class":6},"Maastricht University Medical Center",{"name":69,"class":6},"Medisch Spectrum Twente",{"name":71,"class":6},"HagaZiekenhuis","100504682","phase-3-the-effecttiveness-of-intratympanic-methylprednisolon-injections-compared-to-placebo-in-the-treatment-of-vertigo-attacks-in-menieres-disease-100504682",false,"NCT05851508","The Effecttiveness of Intratympanic Methylprednisolon Injections Compared to Placebo in the Treatment of Vertigo Attacks in Meniere's Disease","A Multicenter, Double-blinded, Randomized, Placebo-controlled Trial to Compare the Effectiveness of Intratympanic Injections methylPREDnisolon Versus Placebo in the Treatment of Vertigo Attacks in MENière's Disease (PREDMEN Trial).","PREDMEN","Inclusion criteria:\n\n• Unilateral, definite MD according to the diagnostic criteria derived from the American Academy Otolaryngology Head and Neck Surgery, Classification Committee of the Bárány Society, European Academy of Otology and Neurotology and International Classification of Vestibular Disorders published in 2015 \\[7\\] (see Appendix 1):\n\nDefinite MD Two or more spontaneous episodes of vertigo, each lasting 20 minutes to 12 hours, AND Audiometrically documented low- to medium-frequency sensorineural hearing loss in one ear, defining the affected ear on at least one occasion before, during or after one of the episodes of vertigo, AND Fluctuating aural symptoms (hearing, tinnitus, or fullness) in affected ear (not better accounted for by another vestibular diagnosis)\n\n* age \\> 18 years at the start of the trial.\n* ≥ 4 vertigo attacks over the last 6 months.\n* willing to adhere to daily trial medications and the follow-up assessments.\n\nExclusion criteria\n\nA potential subject who meets any of the following criteria will be excluded:\n\n* bilateral MD\n* severe disability (e.g. neurological, orthopaedic, cardiovascular) or serious concurrent illness that might interfere with treatment or follow-up.\n* active additional neuro-otologic disorders that may mimic MD (e.g. vestibular migraine, recurrent vestibulopathy, phobic postural vertigo, vertebro-basilar TIAs, acoustic neuroma).\n* otitis media with effusion based on tympanogram results.\n* history of intratympanic injections with corticosteroid less than 6 months ago.\n* history of intratympanic injections with gentamicin or ear surgery for treating MD.\n* pregnant women and nursing women.",true,"ALL","18 Years","100 Years",{"count":85,"type":86},148,"ESTIMATED","INTERVENTIONAL",[89],"PHASE3","Ménière's disease is an inner ear disorder in which patients suffer from attacks of vertigo, tinnitus and hearing loss. To date, it is unclear what the best treatment for this condition is. Giving injections in the inner ear with the adrenal cortical hormone methylprednisolone is a treatment that is already widely used, but still there is insufficient evidence in the effectiveness of this treatment. This multicenter trial compares a patient group which receives injections of methylprednisolone to a patient group which receives placebo injections. Subsequently, dizziness, tinnitus, hearing loss and quality of life will be assed and compared for the above mentioned groups, over a period of one year.",[92],"Meniere Disease",[94,9,95,96,97,98,99,100],"Meniere's disease","Intratimpanic corticosteroids","Dizziness","Hearing loss","tinnitus","aural fullness","randomized control trial","2023-11-28",{"date":103,"type":104},"2023-12-04","ACTUAL",{"date":106,"type":104},"2023-10-01",{"date":108,"type":86},"2027-02-01",{"name":5,"class":6},1]