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• W2054076548 abstract "To evaluate the safety, tolerability, and clinical activity of a single intratympanic injection of OTO-104, sustained-release dexamethasone formulation, in patients with unilateral Ménière's disease.Prospective, double-blind, randomized, placebo-controlled, dose-escalation study of 16 weeks' (4-wk lead-in before dosing; 12-wk follow-up after dosing) duration for each patient.Fifteen centers (physician offices and academic or tertiary referral centers).Forty-four patients aged 22 to 75 years.Single intratympanic injection of OTO-104 (3 or 12 mg) or placebo.Safety and tolerability were assessed via adverse event reports, otoscopy, audiometry, and tympanometry. Clinical activity was assessed primarily as changes in vertigo frequency.OTO-104 was well tolerated, with no impact on hearing function. Plasma levels were observed in a few patients and were barely quantifiable. The most frequently reported adverse event considered related to investigational product was tympanic membrane perforation; no clinical sequelae were associated with these perforations and all were graded mild or moderate. At Month 3, the observed mean ± standard deviation (SD) change from baseline in vertigo frequency was -0.124 ± 0.153, -0.147 ± 0.166, and -0.211 ± 0.153 for the placebo, 3-mg OTO-104, and 12-mg OTO-104 groups, respectively; corresponding to 42%, 56% and 73% reductions in vertigo frequency, respectively. Similar results were observed for tinnitus, measured by the Tinnitus Handicap Inventory (THI-25).OTO-104 was safe and well tolerated. Although the sample size was small, the data suggest 12 mg of OTO-104 was associated with a clinically meaningful reduction in vertigo frequency compared to placebo 3 months after treatment." @default.
• W2054076548 created "2016-06-24" @default.
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• W2054076548 date "2012-09-01" @default.
• W2054076548 modified "2023-10-01" @default.
• W2054076548 title "A Randomized, Double-Blind, Placebo-Controlled Clinical Study to Assess Safety and Clinical Activity of OTO-104 Given as a Single Intratympanic Injection in Patients With Unilateral Ménière’s Disease" @default.
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• W2054076548 doi "https://doi.org/10.1097/mao.0b013e318263d35d" @default.
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