Ontology highlight
ABSTRACT:
SUBMITTER: Lambert PR
PROVIDER: S-EPMC5414596 | biostudies-literature | 2016 Dec
REPOSITORIES: biostudies-literature
Lambert Paul R PR Carey John J Mikulec Anthony A AA LeBel Carl C
Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology 20161201 10
<h4>Objective</h4>To evaluate safety and efficacy of a single intratympanic injection of OTO-104, sustained-exposure dexamethasone, in patients with unilateral Ménière's disease.<h4>Study design</h4>Randomized, double-blind, placebo-controlled, Phase 2b study over 5 months.<h4>Setting</h4>Fifty-two academic and community otolaryngology centers.<h4>Patients</h4>One hundred fifty four patients (77 per group) aged 18 to 85 years inclusive.<h4>Intervention</h4>Single intratympanic injection of OTO-1 ...[more]