Intratympanic Sustained-Exposure Dexamethasone Thermosensitive Gel for Symptoms of Ménière's Disease: Randomized Phase 2b Safety and Efficacy Trial
| Autor: | Paul R. Lambert, Carl Lebel, Anthony A. Mikulec, John P. Carey |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Adult
medicine.medical_specialty Placebo Dexamethasone law.invention 03 medical and health sciences Tinnitus Young Adult 0302 clinical medicine Randomized controlled trial Double-Blind Method law Vertigo medicine Clinical endpoint otorhinolaryngologic diseases Medical Neurotology Corticosteroid Humans 030223 otorhinolaryngology Adverse effect Glucocorticoids Meniere Disease Aged Intratympanic Injection Intratympanic biology business.industry Tinnitus handicap inventory Middle Aged medicine.disease biology.organism_classification Sensory Systems Surgery Clinical trial Ménière's disease Treatment Outcome Otorhinolaryngology Anesthesia Delayed-Action Preparations Female Neurology (clinical) sense organs medicine.symptom business 030217 neurology & neurosurgery Meniere's disease |
| Zdroj: | Otology & Neurotology |
| ISSN: | 1537-4505 1531-7129 |
| Popis: | Objective To evaluate safety and efficacy of a single intratympanic injection of OTO-104, sustained-exposure dexamethasone, in patients with unilateral Meniere's disease. Study design Randomized, double-blind, placebo-controlled, Phase 2b study over 5 months. Setting Fifty-two academic and community otolaryngology centers. Patients One hundred fifty four patients (77 per group) aged 18 to 85 years inclusive. Intervention Single intratympanic injection of OTO-104 (12 mg dexamethasone) or placebo. Main outcome measures Efficacy (vertigo) and safety (adverse events, otoscopy, audiometry, tympanometry). Results Primary 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. Conclusion OTO-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 Meniere's disease symptoms. |
| Databáze: | OpenAIRE |
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