Trial reportOtology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology2016
Intratympanic Sustained-Exposure Dexamethasone Thermosensitive Gel for Symptoms of Ménière's Disease: Randomized Phase 2b Safety and Efficacy Trial.
Trial report in Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 5 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
24 citing papers in PubMed, 5 syntheses or guidelines pooled it, 54 citations in OpenAlex.
- Intratympanic corticosteroid injection for Ménière's disease: systematic review of randomized controlled trials.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2026Pooled it
- Suicidal Ideation, Behaviors, and Deaths in People With Ménière's Disease: A Systematic Review.Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery · 2025Pooled it
- Intratympanic corticosteroids for Ménière's disease.The Cochrane database of systematic reviews · 2023Pooled it
- Effects of intratympanic gentamicin and intratympanic glucocorticoids in Ménière's disease: a network meta-analysis.Journal of neurology · 2022Pooled it
- Prevention of cisplatin-induced ototoxicity in children and adolescents with cancer: a clinical practice guideline.The Lancet. Child & adolescent health · 2020Guideline
- Safety of Repeated-Dose Intratympanic Injections with AM-101 in Acute Inner Ear Tinnitus.Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery · 2017Trial
- Drug Nanocrystal-Loaded Thermo-Reversible Hydrogels of Dexamethasone Palmitate for Intratympanic Drug Delivery.Journal of functional biomaterials · 2026Article
- Dual-target corticosteroid therapy for refractory Ménière's disease: influence of vestibular aqueduct patency and endotypes.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2025Article
- Treatment of Menière's disease: a scoping review of the current evidence.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2025Article
- Developing a core outcome set for Menière's disease trials, the COSMED study: a scoping review on outcomes used in existing trials.Frontiers in neurology · 2025Review
- Precision medicine: a new era for inner ear diseases.Frontiers in pharmacology · 2024Review
- Inner Ear Diagnostics and Drug Delivery via Microneedles.Journal of clinical medicine · 2022Review
- Hearing loss: The final frontier of pharmacology.Pharmacology research & perspectives · 2022Review
- Hearing Function, Degeneration, and Disease: Spotlight on the Stria Vascularis.Frontiers in cell and developmental biology · 2022Review
- [Development of novel drug carrier via round window membrane].Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology head and neck surgery · 2021Review
- Promising Applications of Nanoparticles in the Treatment of Hearing Loss.Frontiers in cell and developmental biology · 2021Review
- Developments in Bio-Inspired Nanomaterials for Therapeutic Delivery to Treat Hearing Loss.Frontiers in cellular neuroscience · 2019Review
- Comparison of the Pharmacokinetic Properties of Triamcinolone and Dexamethasone for Local Therapy of the Inner Ear.Frontiers in cellular neuroscience · 2019Article
- Local Drug Delivery for the Treatment of Neurotology Disorders.Frontiers in cellular neuroscience · 2019Review
- Pharmacokinetic principles in the inner ear: Influence of drug properties on intratympanic applications.Hearing research · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo evaluate safety and efficacy of a single intratympanic injection of OTO-104, sustained-exposure dexamethasone, in patients with unilateral Ménière's disease. STUDY
designRandomized, double-blind, placebo-controlled, Phase 2b study over 5 months.
settingFifty-two academic and community otolaryngology centers. PATIENTS: One hundred fifty four patients (77 per group) aged 18 to 85 years inclusive.
interventionSingle intratympanic injection of OTO-104 (12 mg dexamethasone) or placebo.
main outcome measuresEfficacy (vertigo) and safety (adverse events, otoscopy, audiometry, tympanometry).
resultsPrimary endpoint (change from baseline in vertigo rate at Month 3) was not statistically significant (placebo [-43%], OTO-104 [-61%], P = 0.067). Improvements with OTO-104 were observed in prospectively defined secondary endpoints number of days with definitive vertigo, (Month 2 [P = 0.035], Month 3 [P = 0.030]), vertigo severity (Months 2-3, P = 0.046) and daily vertigo counts (Month 2, P = 0.042), and in some Short Form-36 (SF-36) subscales (Month 2 bodily pain P = 0.039, vitality P = 0.045, social functioning P = 0.025). No difference in tinnitus loudness or tinnitus handicap inventory (THI-25) was observed. OTO-104 was well tolerated; no negative impact on safety compared with placebo. Persistent tympanic membrane perforation was observed in two OTO-104 treated patients at study end.
conclusionOTO-104 was well-tolerated, did not significantly affect change from baseline in vertigo rate, but did reduce number definitive vertigo days, vertigo severity, and average daily vertigo count compared with placebo during Month 3. Results provide insight into analyzing for a vertigo treatment effect and support advancing OTO-104 into Phase 3 clinical trials for the treatment of Ménière's disease symptoms.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.